The S.D.M. Dietary Protocol · 6 The method THE METHOD T he S.D.M. protocolconsists of a normo-protein Very Low Ketogenic Diet (VLCKD < 800 calories)with a low carbohydrate content

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The S.D.M.Dietary Protocol

S.D.M. s.r.l. Società Dietetica MedicaVia dell’Artigianato 45 12038 SAVIGLIANO (CN)Tel. +39 0172 64 80 00 Fax +39 0172 64 88 70 [email protected] www.dietasdm.it

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Preface

Since 1995/1997 S.D.M., the Società-Dietetica-Medica (Medical Dietary Society), has offered effective, easy-to-manage instruments for the treatment of excess body weight and, consequently, of

weight-related pathologies. The S.D.M. protocol was developed in collaboration with Professor Marineau, a student of Professor Blackburn, creator of the first Protein Diet protocol.

The S.D.M. protocol is strictly medicalized and enables the expert nutritionist to achieve excellent results in reduced timespans.

S.D.M. gives paramount importance to the quality of its products and uses the latest technology to ensure foods with high nutritional value, in compliance with European H.A.C.C.P and ISO 9001 standards. The raw materials used come entirely from European sources, in conformity with EU legislation.

Uniquely in Italy, S.D.M. aims not only to support the nutrition expert in prescribing and managing the dietary therapy, but also to accompany its customers during their weight-lossprocess.

S.D.M. srlSocietà Dietetica Medica

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IndexPreface 3

Brief history 5

The method 6

Molecular mechanisms 6 Who the S.D.M. protocolis for 9 Who should NOT use the S.D.M. protocol 9 Advantages of the S.D.M. protocol 10 • For the nutrition expert • For the patient Possible mild side effects of the S.D.M. protocol 11

Macro- and micro-nutrientsin the S.D.M.diet 12

Carbohydrates 12 Proteins 12 Lipids 13 UNICOMPLEX 13 Fluid intake 13

Management of the patient 14

First appointment 14 Subsequent appointments 14

The S.D.M.dietary therapy 15

Attack phase 15 The “classic” diet 15 • Example day 16 The mitigated diet 17 • Example day 18

Transition 19 Introduction The metabolic response of the body to calorie restriction in VLCKD and the need for gradual increase in calorie intake 19 The four steps of the transition 22 • Transition –1stStep 22 • Transition –2ndStep 23 • Transition –3rdStep 23 • Transition –4th Step 23 • Transition phase following a weight-losing diet with 3 meals 24 • Transition phase following a weight-losing diet with 4 meals 25 • Transition phase following a weight-losing diet with 5 meals 26 • Transition phase following a weight-losing diet with 6-7 meals 27

Maintenance 29

Conclusions 30

References 31

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Brief history

In 1971, after extensive studies, Professor Blackburn, a professor at Harvard University, outlined the principles of the Protein Diet, which he defined as Protein Sparing Modified Fasting (Lidner and Blackburn

1976).

Later, in 1975, Professor Marineau, his student, defined the protocol as “Jeuneproteine” (protein fasting) for a clearer distinction between Blackburn’s method and the high-protein Atkins-type diets (Marineau 2004).

In the following years, the protocol method (which is best defined as a Very Low Calorie Ketogenic Diet, VLCKD) spread rapidly and internationally among nutrition specialists: millions of patients have been treated successfully.

In 1993 the Ministry of Health of the United States, through a task force, validated the VLCKD protocol (JAMA 1993). In the same period S.D.M., in close collaboration with Professor Marineau, developed the method on which the current protocol is based. In 2003, the Finnish Ministry suggesteda VLCKD as first-line therapy for the treatment of obesity associated with risk factors (type 2 diabetes mellitus, insulin resistance, dyslipidaemia, hypertension).

In 2014 the Italian Association of Dietetics and Clinical Nutrition (ADI) suggested the ketogenic diet as a validated clinical therapy for the treatment of obesity and its complications (Pezzana, Amerio et al. 2014).

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The method

THE METHOD

The S.D.M. protocolconsists of a normo-protein Very Low Ketogenic Diet (VLCKD < 800 calories)with a low carbohydrate content (about 50-70g of carbohydrates per day).

The protocol has three phases:

I Attack phase: ketogenic metabolism is triggered by the reduced carbohydrate intake. As an accessory phe-nomenon to lipolysis and the catabolism of the fat reserves of adipose tissue, there is a physiological production of ketone bodies (aceto-acetate, β-hydroxybutyrate, acetone), which are a water-soluble share of energy, readily available to many of the tissues of the body (brain, heart and muscle). Continuedketogenesis, besidesproviding an adequate energy supply, is important to ensure the absence of hunger and the feeling of wellbeing throughout the period of weight-loss.

II Transition phase: gradual reintroduction of traditional foods. In this phase the patient is re-educated to a healthy and correct lifestyle, in order to optimise and stabilise the results obtained in the attack phase.

III Mediterranean diet: the patient has achieved the overall targets agreed with the nutrition expert and starts correct long-term nutritional behaviour following the RDAs (Recommended Daily Allowances of nutrients and energy).

S.D.M. offers specific products for the first and second phases. Transition phase products can also be used in the maintenance of the dietary equilibrium.The S.D.M. method provides patient with an amount of high biological value proteins that is calculated on the estimated ideal weight (from 1 to 1.4 g (max.) of protein/kg ideal body weight/day). The S.D.M. method is therefore safe and suitable for a broad spectrum of patients, even complex ones, unlike the high-protein diets (EFSA Panel on Dietetic Products Nutrition and Allergies 2015).

Molecular mechanisms

The S.D.M. dietary protocol has a reduced carbohydrate content, which lowers the levels of insulin in the blood and reduces this hormone’s antilipolytic activity, in favour of an increase in glucagon levels. These effects result in an increase in the catabolism of triglyceride reserves mobilised from white adipose tissue,which are hydrolysed by

lipoprotein-lipase and thereby converted into free fatty acids and glycerol (Nelson andCox2014). (Figure 1)

The fatty acids and glycerol are used only in part as an energy substrate: in detail, skeletal muscles use 40% of the free fatty acids, while hepatocytes transform 10% of the mobilised glycerol into glucose (Alberts, Johnson et al., 2002 ). (Figure 1) The rest of the glycerol and fatty acids is metabolised in the liver in the processes of gluconeogenesis and ketogenesis, respectively. Gluconeogenesis represents the metabolic pathway for synthesising glucose from non-carbohydrate sub-strates and is triggered rapidly in the absence of glucose, through the effect of glucagon. Ketogenesis is the reversible pro-cess of condensation of acetyl-CoA molecules through which ketone bodies (acetone, acetoacetate and β-hydroxy-bu-tyrate) are synthesised and requires at least 24-48 hours to be activated (Nelson and Cox 2014). (Figure 2)

In the lack of glucose, ketone bodies are readily used as a source of energy by skeletal muscles, the central nervous system and cardiac tissue. In these tissues, ketone bodies are oxidized to acetyl-CoA, the metabolic substrate of the Krebs cycle. At the same time, the nutritional characteristics of the S.D.M. products (proteins of high biological value

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and limited carbohydrate content), ensure the stability of blood glucose, through the mechanism of hepatic and renal gluconeogenesis (Nelson andCox2014). (Figure 1)

The latter phenomenon promotes a basal secretion of insulin which helps to keep the blood ketone levels stable: in fact, a feedback mechanism between the levels of ketone bodies and the release of insulin is triggered. In this regard, insulin plays a modulatory role on ketogenesis itself, making it impossible for pathological keto-acidosis, typical of type I or insulin-dependent diabetes mellitus, to become established (Alberts, Johnson et al. 2002, Nelson and Cox 2014).

During the S.D.M. diet, the main source of energy comes from the catabolism of the lipidstores, thus causing an efficient, rapid and steady weight loss at the expense of fat mass. In parallel, the lean body mass is preserved, thanks to the contribution of normoprotein S.D.M. foods, thus improving the patient’s body composition.In summary, the S.D.M. protocol, managed by a nutrition expert, is safe and effective for a wide range of patients, including complex individuals.

THE METHOD

Lactate

Aminoacids

Protein supply

Gluconeogenesis

Restricted supply of carbohydrates

Other organs

Fatty acids

Triglycerides

Glycerol

Urine

EnergysubstratesUrea

GlucoseKetonebodies

Figura 1. Thanks to the restricted intake of carbohydrates, the SDM diet lowers the levels of insulin in the blood and reduces the activity of this hormone, promoting lipolysis and consequent ketogenesis, thereby providing the energy required to the central nervous system (ketones readily cross the blood-brain barrier) and other tissues. The contribution of pre-assimilable protein supplements, of high biological value, effectively protects muscle mass.

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Figura 2. Metabolic pathways activated in liver cells as a result of low blood glucose levels: gluconeogenesis,which produces glucose molecules, and ketogenesis, which produces ketone bodies. The same pathways are used in the opposite direction in, respectively, gluco-dependent cells (adrenal cells and red blood cells) and skeletal muscle and the central nervous system as a source of metabolic energy.

THE METHOD

Glucose

Gluconeogenesis Glycolysis

Glucose

Glucose-6-phosphate

Phosphoenolpyruvate Pyruvate

Lipolysis

Hydrolysis of fatty acids

Acetyl CoA

Acetate

Acetoacetate Hydroxybutyrate

Ketone bodies

Citrate

SuccinateFumarate

Malonate

CO2

Oxalacetate

TCA cycle

alpha-Ketoglutarate

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Who the S.D.M. protocol is for Obese (BMI greater than 30) and overweight (BMI greater than 25) subjects (Lidner and Blackburn 1976, Sukkar,

Signori et al. 2013, Castaldo, Palmieri et al. 2015, Obesity August 25, 1993).

Overweight individuals with comorbid conditions(type II diabetes mellitus, dyslipidaemia, metabolic syndrome, nocturnal apnoea syndrome, asthma) (Mobbs, Mastaitis et al. 2013, Paoli, Rubini et al. 2013, Feinman, Pogozelski et al. 2015).

Pre-bariatric or obese patients, candidates for other types of surgery, to reduce the surgical/anaesthesiological risk (Lidner and Blackburn 1976, Paoli, Rubini et al. 2013, Sukkar, Signori et al. 2013, Vesely and DeMattia 2014, Castaldo, Palmieri et al. 2015).

Women who remain obese or overweight at the end of pregnancy and breastfeeding (Sumithran, Prendergast et al. 2013).

Women in menopause (Sumithran, Prendergast et al. 2013).

Males and females with obesity-related Infertility and polycystic ovary syndrome (Mavropoulos, Yancy et al. 2005, Kulak andPolotsky 2013).

Obese and over weight patients with migraine (Maggioni, Margoni et al. 2011, Di Lorenzo, Coppola et al. 2015).

Aesthetic reasons, localised adiposity.

Who should NOTuse the S.D.M. protocol Subjects with type I, insulin-dependent diabetesmellitus.

Patients with severe liver failure (active chronic hepatitis, cirrhosis of the liver)

Patients with renal failure (serum creatinine greater than 1.5 mg/dl or GFR <60 ml/min).

Patients with serious cardiac disorders: heart failure, atrioventricular block, arrhythmias.

Patients who have had a myocardial infarction or stroke in the 3 months prior to beginning the dietary treatment.

Subjects with severe psychiatric disorders (especially eating behaviour disorders).

Individuals under treatment with non-potassium-sparing diuretics who have unbalanced hypokalaemia.

Subjects on chronic, systemic therapy with corticosteroids.

Pregnant and breastfeeding women (Sussman, Ellegood et al. 2013)

Children and adolescents during the growth phase.

(Mobbs, Mastaitis et al. 2013, Paoli, Rubini et al. 2013, Sussman, Ellegood et al. 2013, Armeno, Caraballo et al. 2014, Castaldo, Palmieri et al. 2015, Paoli, Bianco et al. 2015, Paoli, Bosco et al. 2015).

THE METHOD

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THE METHOD

Advantages of the S.D.M. protocolFor the nutrition expert:

Medicalised protocol.

Control of patient compliance with the dietary therapy (keturtest).

Simplicity of prescription.

Support from the company.

For the patient:

Lack of hunger and sensation of well-being (Gibson, Seimon et al. 2015).

Rapid weight loss.

Lean body mass preserved (Pezzana, Amerio et al. 2014, EFSA Panel on Dietetic Products Nutrition andAllergies2015).

Durable results.

Dietary re-education (Paoli, Rubini et al. 2013).

Harmonious weight loss and respect of skin elasticity.

Possible mild side effects of the S.D.M. protocol Headache: analgesics.

Halitosis: S.D.M. mints q10.

Irregular bowel habit (constipation or diarrhoea): S.D.M. Fibromanna.

Transient alterations of the menstrual cycle.

Postural hypotension, dizziness, nausea,tachycardia: adapt supplementation of salts, S.D.M. UNICOMPLEX.

Muscle weakness: adapt supplementation of salts, S.D.M. UNICOMPLEX.

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SYMPTOM DIAGNOSIS CAUSES TREATMENT

Persistent hungerFatigue

Using theKeturtest, check for the presence of ketone bodies

in the urine

Intentional or unintentional consumption of sugars

Careful dietary and medication history

Headache during the first 2-3 days Interview

Competition of ketone bodies and glucose in the central

nervous system

Possible prescription of analgesics

DizzinessPostural hypotension

Nausea Tachycardia

InterviewClinical examination

Hyponatraemia causinghypovolaemia

Increase intake of fluids and sodium

Muscle weakness “Lumbago”

Cramps

Interview Clinical examination Hypokalaemia

Check that S.D.M. UNICOMPLEX is being taken correctly and, if necessary, increase the intake

of potassium

Halitosis Interview Elimination of ketone bodies via the lungs S.D.M. mints q10

Constipation Interview Change of dietIncrease fluid intake

Evaluate intake of oil and S.D.M. Fibromanna

Diarrhoea Interview Change of dietDecreased intake of fibre

Fibre intakeAnti-diarrheal agent

Evaluate hydration and temporary suspension of the diet

Less weight loss than predicted

Clinical examinationKeturtest

Keturtest negative: dietary error (sugar consumption greater than

allowed) Keturtest positive: possible hormonal fluid retention.

Constipation. Excessiveintake of food and/or condiments (oil)

Correct dietary errorsReassure the patient.

S.D.M. Fibromannaand/or S.D.M. Draincell

THE METHOD

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MACRO- AND MICRO-NUTRIENTS IN THE S.D.M. DIET

Carbohydrates

The S.D.M. protocol is designed to provide about 50-70 g/day of carbohydrates, which leads, in order, to lowering the levels of insulin and reducing its anti-lipolytic activity. This is important to ensure a lipolytic process (and therefore weight loss) that is constant and moderate, as well as stable ketogenesis, useful for eliminating hunger pangs and for

conferring a feeling of well-being during the diet.The amount of carbohydrates in the protocol is also essential to providea supply of energy to the gluco-dependent cells that do not contain mitochondria (red blood cells, adrenal cells) (Pezzana, Amerio et al. 2014, EFSA Panel on Dietetic Products Nutrition andAllergies 2015).The daily intake should not, however, exceed 1 +/-0,1 g/kg of ideal weight. Higher values inhibit ketogenesis and cancel the anorectic effect.The carbohydrates eaten during the dietary therapy can be complex (fibre) or simple, present in vegetables and S.D.M. products themselves. In order to control the daily glucose intake, S.D.M. proposes a list of vegetables with a low carbohydrate content (group 1), which the patient can consume at will, and a second list (group 2) of those that should be consumed in only limited quantities.

Proteins

The S.D.M. diet is classified among normo-protein protocols (0.9-1.4 g/kg of ideal weight, table 1) (Pezzana, Amerio et al. 2014, EFSAPanel on Dietetic Products Nutrition and Allergies 2015). S.D.M. products are made using high biological value proteins all from the European foodchain.

Table 1. Minimum and maximum recommended protein intake in obese patients about 40 years old according to the EFSA 2015 (EFSA Panel on Dietetic Products Nutrition and Allergies 2015).

Macro- and micro-nutrients in the S.D.M. diet

BMI (Kg/m2)

Weight(Kg)

REE Mifflin (Kcal/die) (a) Factor (b) Min.

(g/die) (c)

Max. (g/die) (d)

MAN(Age 40, height 177 cm)

22 (reference subject) 69 1901 1.00 57 115

25 78 1694 1,06 61 121

27,5 86 1773 1.11 63 127

30 94 1851 1,16 66 132

35 110 2008 1,25 72 144

40 125 2164 1,35 77 155

45 141 2321 1,45 83 166

50 157 2478 1,55 89 177

WOMAN(Age 40, height 163 cm)

22 (reference subject) 58 1238 1,00 48 96

25 66 1322 1,07 51 103

27,5 73 1388 1,12 54 108

30 80 1455 1,18 57 113

35 93 1588 1,28 62 123

40 106 1721 1,39 67 134

45 120 1853 1,50 72 144

50 133 1986 1,60 77 154(a) : Resting Energy Expenditure Kcal/die: Men= (weight in kg x 10) + (height in cm x 6.25) - (age x 5) + 5; Women= (weight in kg x 10) + (height in cm x 6.25) - (age x 5) - 161.(b) : REE BMI obese or overweight subject/ REE BMI normal reference weight subject.(c) : 0.83 g/Kg reference body weight (BMI 22 Kg/m2 ) per day x factor.(d) : 1.66 g/Kg reference body weight (BMI 22 Kg/m2 ) per day x factor.

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Lipids

The S.D.M. protocol is designed to include indispensable integration with extra virgin olive oil (10 grams, corresponding to about 2 teaspoons), a source of essential fatty acids. This lipid intake is also helpful for promoting good biliary function (Pezzana, Amerio et al. 2014, EFSA Panel on Dietetic Products Nutrition and Allergies 2015).

Complementary intake of S.D.M. OMEGA 3 is also proposed, since this helps to optimise the catabolism of triglycerides and, at the same time, has a protective eff ect on the cardiovascular system.

UNICOMPLEX

It is an indispensable part of the S.D.M. protocol to supplement the micro-elements, present in the vegetables allowed, by using S.D.M. UNICOMPLEX, a unique supplement

that contains a full complement of mineral salts and vitamins.

Of the possible side eff ects that may occur during the S.D.M. dietary therapy, 95% are due to inadequate supplementation of micro-nutrients. A ketogenic diet does, in fact, cause a physiological increase in the renal excretion of mineral salts (potassium, sodium, calcium, magnesium), which passively follow the renal clearance of ketone bodies.

Excluding some macronutrients that are a source of mineral salts from the daily diet can contribute to further reducing the basic reserves.Guaranteeing the correct supply of mineral salts and vitamins is essential in order to maintain optimal cell function: for this reason, the S.D.M. UNICOMPLEX completely covers the daily requirements of all the main micro-nutrients (table 2).

Table 2. Micro-nutrient formulation of S.D.M. UNCOMPLEX.

Fluid intake

It is recommended that the patient drinks at least 2 litres of water per day, which can be in the form of unsweetened infusions, since this is indispensable to compensate for the increased requirement during the dietary therapy (Pezzana, Amerio et al. 2014, EFSA Panel on Dietetic

Products Nutrition and Allergies 2015).

MACRO- AND MICRO-NUTRIENTS IN THE S.D.M. DIET

Ingredients per dose (2 sachets) RDA / dose

Potassium 2000 mg 100

Calcium 800 mg 100

Magnesium 375 mg 100

Zinc 10 mg 100

Manganese 2 mg 100

Copper 1 mg 100

Iodine 150 mcg 100

Selenium 55 mcg 100

Chrome 40 mcg 100

Vitamin C 80 mg 100

Vitamin PP 16 mg 100

Vitamin E 12 mg 100

Pantothenic acid 6 mg 100

Vitamin B2 1,4 mg 100



Vitamin A 800 mcg 100

Folic acid 200 mcg 100

Vitamin B8 50 mcg 100

Vitamin D 5 mcg 100

Vitamin B12 2,5 mcg 100

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MANAGEMENT OF THE PATIENT

First appointment

In the field of nutrition, it is fundamental that a relationship of mutual trust is established between the patient and the care professional. To this end, it is essential to identify what has motivated the patient to start a diet and,

consequently, his or her expectations about it. A good initial approach leads to greater compliance both in the short-term and in the long-term, which, together with the efficacy and simplicity of management of the protocol, ensures clinical success.During the first interview, it is important to assess:

• Medical history and evaluation of laboratory parameters: blood count, blood glucose, blood urea nitrogen, uric acid, ALT, AST, serum HDL-LDL cholesterol level, creatinine, Na-K electrolyte balance

• Anyongoing medication use,• Weight trends over time,• Eating habits,• General anthropometric values: weight, height, circumferences, skinfolds,

impedance analysis.

Based on the clinical and individual needs of the patient, a personalised S.D.M. diet is prescribed: this can be administered in the “classic” or “mitigated” form (see next chapter).

Advice: faced with a severely overweight patient, it is important not to make the subject feel guilty and to propose reasonably attainable intermediate objectives. It is advisable to fix the date of the second follow-up appointment 10-15 days after the first appointment, to ensure the patient’s real compliance and proper management of the protocol and to evaluate the first results.

Subsequent appointments

It is suggested that follow-up visits are performed on a monthly basis, although they can be more or less frequent at the discretion of the care professional.If ketogenesis is maintained for a prolonged period, it is advisable to repeat the

blood-biochemistry analyses.

The follow-up visits are used to evaluate the results achieved byre-analysing the anthropometric values and to discuss any problems arising during the first period of the diet, so as to strengthen the relationship between the patient and the care professional.

Management of the patient

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FOODS ALLOWED:• Zero/low calorie drinks• Unsweetened tea/coffee• Unsweetened infusions• Herbs, aromatic plants, spices and powdered

aromas

MOST COMMON MISTAKES:• Sweetened tea/coffee• Barley coffee• Fruit-based low calorie drinks;• Supplements other than S.D.M. UNICOMPLEX

which contain assimilablesugars;• Consumption of unpermitted vegetables.

The “classic” diet

The S.D.M. protocol includes a first phase in which all the meals are replaced by S.D.M. products, associated with vegetables with a low content of carbohydrates. It is essential to provide supplementary trace elements, mineral salts and vitamins. S.D.M. has developed a specific supplement for this purpose, which simplifies the management for

both the nutritionist and the patient: S.D.M. UNICOMPLEX.

Use the following table to determine the number of daily meals :

Height in cm <160 160-170 170-180 >180

Women 3-4 meals 4 meals 4-5 meals 5 mealsMen 5 meals 5 meals 6 meals 6-7 meals

Supplementation:• UNICOMPLEX: 2 sachets/day (table 2), indispensable.• Omega 3: 2 capsules/day, optional, promotes the catabolism of triglycerides and lowers cardiovascular risk,• Fibromanna: 1 sachet/day, optional, promotes intestinal transit,• Probio (lactic ferments): 2 capsules/day, optional, rebalances the intestinal flora,• For women, Draincell: 2 caps in 1 litre of water, optional, in the case of water retention.

The S.D.M. dietary therapy

Vegetables without restriction:• Salads: Lettuce, Corn salad, Belgian endive, Rocket,

Chicory, Endive, Escarole, Treviso salad, Red and green radicchio.

• Cabbages: Radish, Cauliflower.• Leafy vegetables: Chard, Spinach, Celery, Turnip

greens.• Cucumber.• Mushrooms: Champignon, Caesar, Boletus.• Zucchini, zucchini flowers.• Cardoon.

Vegetables to limit(maximum 180g/die):

• Cabbages: Broccoli, Cabbage, Sprouting broccoli, Romanesco, Headed cabbage, Savoy cabbage, Chinese cabbage.

• Fennel

Recommended physical activity:Moderate aerobic activity, such as walking 30-45 minutes a day.

MANAGEMENT OF THE PATIENT

THE ATTACK PHASE

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EXAMPLE DAY:

Alternatives for Breakfast:

S.D.M. Cappuccino S.D.M. Zwieback with 2/3 teaspoons of S.D.M.low calorie jam/hazelnut spreadand coffee S.D.M. Shortbreadwith tea S.D.M. Sea biscuitswith tea S.D.M. Milk cornflakes S.D.M. Pancake

Alternatives for the Mid-morning snack:

S.D.M. Bar S.D.M. Wafer S.D.M. Shortbread S.D.M. Yoghurt-tasting drink S.D.M. Stuzzichelle

AlternativesforLunch (associated with vegetables):

S.D.M. Pasta carbonara S.D.M. Cream soup. S.D.M. Focaccia with vegetables S.D.M. Readymade meals

Alternatives for the Mid-afternoon snack:

S.D.M. Macaroons S.D.M. Hot chocolate S.D.M. Readymade puddings S.D.M. Procrockbiscuit S.D.M. Soya nuts S.D.M. Peach tea

AlternativesforDinner (associated with vegetables):

S.D.M. Omelette S.D.M. Risotto S.D.M. Breadsticks with salad S.D.M. Vegetable soup S.D.M. Soup

LA TERAPIA DIETETICA S.D.M.

The “classic” diet

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The mitigated diet

The S.D.M. protocol offers the possibility of following the diet while including a serving of meat, fish or eggs, during one of the main meals in replacement of an S.D.M. food, together with vegetables with a low carbohydrate content. This allows ketogenesis to be triggered, with resulting weight loss, and at the same time grants the patient a discrete

conviviality. The “mitigated” diet can also be considered the phase following the “classic” diet. Supplementation of trace elements, mineral salts and vitamins (S.D.M. UNICOMPLEX) is essential in this protocol, too.

Use the following table to determine the number of daily meals:

Height in cm <160 160-170 170-180 >180

Women 2-3 meals 3 meals 4 meals 4-5 mealsMen 4 meals 4 meals 5 meals 5-6 meals

Supplementation:• UNICOMPLEX: 2 sachets/day (table 2), indispensable.• Omega 3: 2 capsules/day, optional, promotes the catabolism of triglycerides and lowers cardiovascular risk,• Fibromanna: 1 sachet/day, optional, promotes intestinal transit,• Probio (lactic ferments): 2 capsules/day, optional, rebalances the intestinal flora,• For women, Draincell: 2 caps in 1 litre of water, optional, in the case of water retention.


Free meal:• Animal proteins: Lean beef: Tenderloin, Sirloin, Topside, Silverside,

Rump, Lean thick flank, Lean beef-burger, Carpaccio. White meat: Chicken, Turkey, Rabbit. Cold cuts: Bresaola, Raw ham with fat removed, Lean fish: Bream, Bogue, Snapper,Smooth-

hound, Sole, Seabass, Tub gurnard, Perch, Monkfish, Branzino, Gilthead, Mullet, Trout, John Dory,Squid, Octopus, Cuttlefish, Musky octopus, Cod,

Shellfish: Prawns, Lobster, Crayfish, Slipper lobster, Semi oily fish: Anchovy, Sardine, Tuna, Swordfish,

Carp, Tench.

Vegetables without restriction:• Salads: Lettuce, Corn salad, Belgian endive, Rocket,

Chicory, Endive, Escarole, Treviso salad, Red and green radicchio

• Cabbages: Radish, Cauliflower• Leafy vegetables: Chard, Spinach, Celery, Turnip

greens• Cucumber,• Mushrooms: Champignon, Caesar, Bolelus• Zucchini, Zucchini flowers,• Cardoon.

FOODS ALLOWED:• Zero/low calorie drinks• Unsweetened tea/coffee• Unsweetened tisanes• Herbs, aromatic plants, spices and powdered aromas

MOST COMMON MISTAKES:• Sweetened tea/coffee• Barley coffee• Fruit-based low calorie drinks;• Supplements other than S.D.M. UNICOMPLEX

which containassimilablesugars;• Consumption of unpermitted vegetables

Vegetables to limit (maximum 180g/die):• Solenaceae: Aubergine, Tomato, Pepper• Artichoke, Asparagus, Brussels sprouts, String beans,

Boiled yellow squash, Turnip,• Cabbages: Broccoli, Cabbage, Sprouting broccoli,

Romanesco, Headed cabbage, Savoy cabbage, Chinese cabbage, Brussels sprouts

• Leafy vegetables: Chard, Spinach, Celery, Turnip tops, Fennel, Leek

• Soya bean sprouts.

Recommended physical activity: moderate aerobic activity, such as walking 30-45 minutes a day.

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EXAMPLE DAY:

Alternatives for Breakfast

S.D.M. Cappuccino S.D.M. S.D.M. Zwieback with 2/3 teaspoons of S.D.M. low calorie jam/hazelnut spread and coffee S.D.M. Shortbread with tea S.D.M. Sea biscuits with tea S.D.M. Milk cornflakes S.D.M. Pancake

Alternatives for the Mid-morning snack:

S.D.M. Bar S.D.M. Wafer S.D.M. Shortbread S.D.M. Yoghurt-tasting drink S.D.M. Stuzzichelle

Alternatives for Lunch/Dinner (associated with vegetables):

S.D.M. Pasta carbonara S.D.M. Cream soup. S.D.M. Focaccia with vegetables S.D.M. Readymade meals

Alternatives for the Mid-afternoon snack:

S.D.M. Macaroons S.D.M. Hot chocolate S.D.M. Readymade puddings S.D.M. Procrock biscuit S.D.M. Soya nuts S.D.M. Peach tea


The mitigated diet

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The transition

Introduction

The transition is an extremely important phase of the S.D.M. di-etary protocol as it allows stabilisation of the weight reached, thanks to the gradual and careful increase of the daily calorie intake.

Precisely because of its strategic role, the transition phase must be undertaken both by those who have achieved their goal weight and by those who wish to take a break or suspend the diet itself.

The scientific rationale of the transition phase has been determined based on clinical experience, gained over the years, and evidence in the international literature and can be summarised in the following points:

The metabolic response of the body to the calorie restriction of aVLCKD and the consequent need for a gradual increase in calories.

It is known that, as a result of any calorie restriction, the basal metabolism (BM) of an individual tends to decrease gradually. The reduction of the BM can be between 17% and 25% and this effect becomes more significant as the entity and duration of the calorie restriction increase (Leibel, 1995).

According to a similar phenomenon it is easy to understand that, at the end of a VLCKD protocol, when the patient resumes a diet with a significantly much higher calorie intake, one of the body’s priorities would be immediate restoration of the reserves of adipose tissue (return to set-point) (Lidner and Blackburn 1976 Keesey1997, Blackburn 2007).

For this reason it is essential to re-introduce the foods, and therefore calorie intake, gradually, so as to induce an equally gradual and proservingal increase in the subject’s basal calorie consumption (Gripeteg, Torgerson et al. 2010). As demonstrated by the study by Gripeteget al. the duration of the transition phase and the graduality of calorie increase, together, enable achievement of the bestmedium- and long-term results with regards to both weight maintenance and some clinical parameters.

In this study, at the end of a VLCKD protocol (<800 calories/day) lasting 12 weeks, two groups of patients who achieved a significant percentage reduction of weight (about - 18%) began a transition phase of different duration.In the long-term (52 weeks), the group of 65 patients that followed a transition phase lasting 6 weeks maintained the results achieved with the VLCKD, compared to the group of 58 patients who followed a transition phase of only 1 week (p = 0.006 ). In the same study, the patients in the group that followed a transition period lasting 6 weeks maintained, over time, a significant reduction in waist circumference and systolic and diastolic blood pressure, compared to patients who followed a transition phase lasting just 1 week (Gripeteg, Torgerson et al. 2010).


20

SDM diet 600-800 cal.

1800 cal.

Progressive increase in the BM during the transition

Decrease of 17 to 25% in the BM during active weight loss

Step

1Step

2Step

3Step

4Figure 3. In a patient who has a hypothetical calorie consumption of 1800 Kcal/day, the very low calorie intake of the attack phase causes a reduction in calorie consumption which, according to the literature data and depending on the duration of the weight loss, can be as much as 25%. Weight loss is nevertheless still guaranteed by the low-calorie and reduced carbohydrate supply of the SDM protocol. The progressive increase in calories, provided in each of the four steps of the transition phase, gradually raises the BM.

The importance of an adequate protein supply

During the different steps of the transition phase it is critical that the protein intake is adequate for the needs of the individual subject in order for his or her lean mass to be safeguarded and so that the satiating effect of proteins promotes the patient’s good compliance until completion of the dietary protocol.

The observations of MargrietWesterterp-Plantenga, a leading international expert on the subject, confirm that, at the end of a VLCKD protocol in which there has been a weight loss of 5-10%, a significant supply of proteins in the transition phase and during maintenance affords better stabilisation of results in the medium- and long-term (Westerterp-Plantenga 2004, Lejeune, Kovacs et al. 2005).

In the light of the foregoing considerations, it is advised that the transition phase lasts as long as the phase of weight reduction and that it is divided into four steps.Each step involves an increase of about 200 Kcal (Figure 3), achieved by:

A gradual reduction in the number of S.D.M. protein foods;

An increase in the proserving of carbohydrates, using foods with a low glycaemic index (GI);

Introduction of foods present in the Mediterranean diet;

Gradual reduction of micro-nutrient supplementation.

21

In the above study, at the end of a VLCKD protocol (<800 calories/day) lasting 4 weeks, two groups of previously randomised patients, after having obtained a significant reduction in percentage of body weight (between 5% and 10% ), underwent a transition phase and maintenance with two diets containing different percentages of protein.Over a period of 12 months, compared to the group of 60 patients who followed a transition phase with a protein content of 15% of the daily calorie intake, the group of 53 patients who followed a transition phase with a protein content of 18% of the daily calorie intake had:

less weight gain over time; better body composition (higher percentage of lean mass and lower percentage of body fat); a smaller abdominal circumference; a more constant feeling of satiety; a lower respiratory quotient.

(Westerterp-Plantenga 2004).

In order to ensure optimal protein intake, without increasing the calorie content of each step excessively, the protocol for the transition phase includes the daily consumption of a defined number of S.D.M. protein foods, established on the basis of the course of the VLCKD.

The importance of the daily number of meals

Another interesting aspect, which can influence weight gain, is the number of meals in a day. Investigations carried out so far have shown a lower risk of metabolic syndrome when calorie intake is distributed through the day in four meals rather than in three.

For example, in a study by Chapelotof percentage changes in fat mass and plasma concentrations of leptin in relation to the number of meals in the day, it was seen that the subjects who passed from 4 to 3 daily meals had increases of both fat mass and the level of circulating leptin. The passage, in the same subjects, from 3 to 4 daily meals helpedto reduce fat mass and lower leptin levels (Chapelot, 2006).

In a similar study, Fabry showed the different incidence of clinical aspects of the metabolic syndrome betweena group of patients receiving three or fewer meals in a day compared to a group receiving five or more than five daily meals.The incidences of: excess weight, high cholesterol and insulin resistance were higher among the subjects receiving three meals (or even fewer) in a day. In contrast, the subjects who received five or more meals in a day had significantly lower incidence of these conditions and a higher frequency of laboratory values within the normal range (Fabry, 1994).

In the light of the above considerations, it is recommended that the patient receives at least five daily meals, so as to divide the calorie supply of the macronutrients appropriately.

The importance of the daily glycaemic load

With respect to the calorie intake of carbohydrates, the concept of avoiding carbohydrates with a high glycaemic index remains fundamental (Brand-Miller, Holt et al., 2002, Barclay, Petocz et al. 2008 Vesely and DeMattia 2014), with particular attention to the overall glycaemic load of the diet.

This aspect enables insulin secretion to be kept under control, thus avoiding massive reactivation of lipo-synthesis, which underlies the increase in adipose tissue. According to most experts, a total daily glycaemic load of less than 80 would significantly reduce weight gain after the slimming programme and reduce the risk of insulin resistance in the maintenance phase (Brand-Miller 2008, Afaghi 2012). The transition phase therefore incorporates a gradual reintroduction of carbohydrates, choosing foods with a low glycaemic index and moderating their amount, so as to reduce the glycaemic load of each meal and not exceed the recommended daily total glycaemic load (Vesely and DeMattia 2014).

22

The 4 steps of the transition

Transition – 1stStep Introduction of fruit

Introduction of a 2nd dish at lunchand dinner

FRUIT:Fresh and ideally in season, 1 serving of 100-150 g *.*Theserving of fruitcan be replaced by centrifuged fruit juice or fruit extract.

2nd DISH:Meat (1 servingof about 100-150 g).Lean red (the recommended amount is 1 servingper week): tenderloin, sirloin, topside, silverside, rump, lean thick fl ank, lean beef-burger, carpaccio. White: chicken, turkey, rabbit.Cold cuts (1 serving of about 60 g): bresaola, cooked ham, raw ham or bacon with the fat removed.

Fish (1 servingof about 150-200 g).Lean: Bream, Bogue, Snapper,Smooth-hound, Sole, Seabass, Tub gurnard, Perch, Monkfi sh, Branzino, Gilthead, Mullet, Trout, John Dory, Cod.Oily: Anchovy, Sardine, Tuna, Salmon (including smoked salmon), Swordfi sh, Carp, Tench. Molluscs: Squid, Octopus, Cuttlefi sh, Musky octopus, Shellfi sh: Prawns, Lobster, Crayfi sh, Slipper lobster.

Eggs (2 per serving): maximum 2 servings in a week.

Vegetable-based protein foods (1 servingof about 150-200 g): tofu, seitan, soya, tempeh.

Step I

Introduction of fruit+

Introduction of meat/fi sh/vegetable protein foods at lunch and dinner

Step II

Introduction of dairy products+

Introduction of cereals

Step III

Introduction of oily seeds+

Introduction of legumes

Step IV

Increase of calories through the same foods introduced in the

preceding steps


23

Transition – 2nd step Introduction of dairy products

Introduction of cereals

LOW-FAT CHEESES (1 serving of about 80-100 g): Ricotta (cow’smilk / ewe’smilk), primo sale, cottage cheese.

CEREALS: Low GI S.D.M. tagliatelle, spelt, wheat, barley, wholegrain rice, basmati rice, black rice, amaranth, buckwheat*, quinoa*.Low-carbohydrate wholemeal bread made of rye or spelt, biscuits with a low GI, crispbread.

*although these are not cereals, from a purely nutritional point of view, they can be considered analogues of cereals.

Transition – 3rd step Introduction of oily seeds

Introduction of legumes

OILY SEEDS: Walnuts, hazelnuts, almonds

LEGUMES:Lentils, beans, chickpeas, peas, broad beans, soya beans, edamame.


Transition – 4th step Calorie increase with the same foods as those introduced during the preceding steps.

24


Transitionphase following a weight- losing diet with 3 meals

First step of the transitionBreakfast Mid-morning snack Lunch Mid-afternoon snack Dinner

1 SDM food+

1 serving of fruit1 serving of fruit

A 2nd dish: all the foods in the permitted list are allowed

except low-fat cheeses+

1 servingof unrestricted vegetables

+condiment: 1 tablespoon of

extra virgin olive oil


except low-fat cheeses +

1 servingof unrestricted vegetables +

condiment:1 tablespoon of extra virgin olive oil

Second step of the transitionBreakfast Mid-morning snack Lunch Mid-afternoon snack Dinner

125 g of yoghurt / 1 egg / 2 slices of lean cold cuts / 50 g

of feta /1 SDM transition food

+1 serving of fruit

+2 slices of wholemeal bread

(type, sandwich loaf ) / low GI biscuit /

30 g of muesli

SDM food+

1 serving of fruit

A 2nd dish+




1 serving of fruit

A 2nd dish+




Third step of the transitionBreakfast Mid-morning snack Lunch Mid-afternoon snack Dinner

125 g of yoghurt /1 egg / 2 slices of lean cold cuts / 50 g of feta / 1 SDM transition food

+1 serving of fruit


(type, sandwich loaf )/ low GI biscuit / 30 g of muesli

1 serving of fruit / 20 g of almonds, walnuts or

hazelnuts

1 serving of 70 g of cereal+

A 2nddish+

1 serving di unrestricted vegetables



NB: the food in the 2nd dish and the cereal can be

replaced by a serving of legumes (100 g, cooked

weight)

1 serving of fruit

A 2nddish+




Fourth step of the transitionBreakfast Mid-morning snack Lunch Mid-afternoon snack Dinner

125 g of yoghurt/ 1 egg / 2 slices of lean cold cuts / 50 g of feta /1 SDM transition food

+1 serving of fruit



1 serving of fruit / 20 g almonds, walnuts or

hazelnuts

1 serving da 70 g of cereal +

A 2nddish+






weight)

1 serving of fruit

A 2nddish+

1 servingof cereal 40 g +




25


Transition phase following a weight- losing diet with 4 meals


1 SDM food+

1 serving of fruit SDM food






SDM food







125 g of yoghurt / 1 egg / 2 slices of lean cold cuts / 50 g of feta / 1 SDM transition food

+1 serving of fruit

+2 slices of wholemeal bread (type, sandwich loaf )/low GI

biscuit / 30 g of muesli

SDM food+

1 serving of fruit

A 2nddish+



extra virgin olive oil+

2 slices of wholemeal bread (type, sandwich loaf

SDM food+

1 serving of fruit

A 2nddish+





125 g of yoghurt/1 egg / 2 slices of lean cold cuts / 50 g of feta / 1 SDM transition food

+1 serving of fruit



1 serving of fruit / 20 g di almonds, walnuts or

hazelnuts


A 2nddish+






weight)

SDM food+

1 serving of fruit

A 2nddish+


condiment: 1 tablespoon of extra virgin olive oil



+1 serving of fruit


(type, sandwich loaf ) / low GI biscuit / 40 g of muesli


hazelnuts


A 2nddish+




SDM food+

1 serving of fruit

A 2nddish+

1 servingof cereal 50 g+





weight)

26


Transition phase following a weight- losing diet with 5 meals


1 SDM food+

1 serving of fruit SDM food






SDM food





+SDM food



+1 serving of fruit



SDM food+

1 serving of fruit

A 2nddish+




2 slices of wholemeal bread (type, sandwich loaf )

SDM food+

1 serving of fruit

A 2nddish+

1 serving of unrestricted vegetables

+condiment 15g of extra virgin

olive oil +

SDM food



+1 serving of fruit




hazelnuts

1 servingof 80 g of cereal +

a 2nddish+




SDM food+

1 serving of fruit

A 2nddish+






weight)



+1 serving of fruit




hazelnuts

1 serving of 70 g of cereal +

a 2nddish+






weight)

SDM food+

1 serving of fruit

A 2nddish+



+SDM food

27


Transition phase following a weight- losing diet with 6-7 meals


1 SDM food+

1 serving of fruitSDM food






SDM food

SDM food





+SDM food



+1 serving of fruit

+2 slices of wholemeal bread (type, sandwich loaf/low GI


SDM food+

1 serving of fruit

A 2nddish+




2 slices of wholemeal bread (type, sandwich loaf

SDM food+

1 serving of fruit

A 2nddish+



+SDM food



+1 serving of fruit

+2 slices of wholemeal bread (type, sandwich loaf/low GI



hazelnuts


a 2nddish+




SDM food+

1 serving of fruit

A 2nddish+

1 servingof cereal 50 g +



+SDM food



weight)



+1 serving of fruit

+3 slices of wholemeal bread (type, sandwich loaf / low GI


1 serving of fruit / 20 g ofalmonds, walnuts or

hazelnuts

1 serving of 80 g of cereal +

a 2nddish+




SDM food+

1 serving of fruit

A 2nddish+




NB: the food in the 2nd

dish and the cereal can be replaced by a serving of legumes (150 g, cooked

weight)

28

Supplementation:• UNICOMPLEX: indispensable in the fi rst three steps of the transition. The recommended dose is 2 sachets during step 1, 1sachet during steps 2-3. During step 4, supplementation with Unicomplex is recommended at the discretion of the care professional.• Omega 3: 2 capsules/day, optional, promotes catabolism of triglycerides and lowers cardiovascular risk,• Fibromanna: 1 sachet/day, optional, promotes intestinal transit,• Probio (lactic ferments): 2 capsules/day, optional, rebalances intestinal fl ora,• For women Draincell: 2 caps in 1 litre of water, optional, in the case of water retention.

Unrestricted vegetables: Lettuce, Corn salad, Belgian endive, Rocket, Chicory, Endive, Escarole, Treviso salad, Red

and green radicchio, Radish, Chard, Spinach, Celery, Turnip greens, Green peppers, Fennel, Broccoli, Caulifl ower, Cabbage, Sprouting broccoli, Romanesco, Headed cabbage, Savoy cabbage, Chinese cabbage, Champignon mushrooms, Caesar’s mushrooms, Bolelus, Soya sprouts, Zucchini, Zucchini fl owers, Cucumber, Cardoon, Aubergine, Tomatoes, Yellow and red peppers, Artichokes, Asparagus, Brussels sprouts, String beans, Yellow squash, Turnips, Dandelion.

Condiments:• Extra virgin olive oil: consume the amount presentedfor each step.• Spices: all dried spices, such as oregano, curry, thyme, laurel, etc., are allowed• On pasta: tomato sauce, pesto sauce, fi shsauce.

Physical activity:Regular physical activity is recommended: walking, cycling, swimming for at least 40-45 minutes. The physical exercise can be intensifi ed gradually during the various steps of the transition phase and can also include more vigorous activities such as running, tone-up, aerobics, etc.

THE S.D.M. DIETARY THERAPY

29

Maintenance

Over the years, numerous studies have examined the strategies for maintaining the results obtained with a VLCKD dietary protocol in the medium- and long-term (Desjeux, Gernez-Lestradet et al. 1982, Romon, Edme et al. 1993, Brand-Miller, Holt et al. 2002, OReardon, Ringel et al. 2004, Wing and Phelan 2005, Chapelot, Marmonier et al. 2006,

Thomas, Elliott et al. 2007, Livesey, Taylor et al. 2008, Paddon-Jones, Westman et al. 2008, Larsen, Dalskov et al. 2010, Larsen, Dalskov et al. 2010).

These studies have shown that it is essential to:

• Carry out moderate, aerobic physical activity regularly for 45-60 minutes.

At a metabolic level this causes:

- Reactivation of basal metabolism; - Increased calorie consumption, mobilisation of fat mass; - Preservation of lean body mass;- Resolution of the phenomenon of insulin resistance, as well as more efficient utilisation of carbohydrates and

fats even at rest;- Improvement in respiratory and cardio-circulatory efficiency, with rebalancing of blood pressure and

reduction of resting heart rate; - Improvement of the lipid profile; - Prevention of osteoporosis; - Improvement of bowel function;- Reduction of oxidative stress and improved mood and sleep quality.

• Eat at least five servings of fruit and vegetables, since these are rich in fibre, vitamins, mineral salts and anti-oxidants.

• Maintain a proper level of body fluid by drinking at least 1.5-2 litres of water each day.

• Start the day with a balanced breakfast so that Ghrelin levels are kept under control, thereby reducing hunger during the day (Foster-Schubert, Overduin et al. 2008).

• Distribute the calorie requirements of the day in at least four meals, preferably respecting the following percentages: breakfast 27%, lunch 36%, snack 13% and dinner 24%.

• Eat food with a low glycaemic load and index.

• Ensure that protein intake:

- Is not less than 20% of the total calorie requirements, in order to preserve lean mass;- Is distributed evenly within each meal, to reduce its glycaemic load and have a greater satiating effect

(Chapelot, Marmonier et al. 2006, Tomé 2009).

• Reduce the overall contents of fats, particularly saturated fats, of animal origin, and hydrogenated ones, of vegetable origin.

• Respect the RDA for mineral salts, vitamins and trace elements.

THE S.D.M. DIETARY THERAPY

30

Conclusions

The effectiveness of the whole VLCKD protocol is closely related to strict compliance with the various aspects of the rationale governing the four steps of the transition phase.

The transition must be understood as a real nutritional re-education, during which the patients, by following the entire course, acquire a new awareness that allows them to make better food choices in terms of carbohydrate and lipid content,while restricting calorie intake.

In a VLCKD protocol, weight loss tends to remain constant because of the particular characteristics of the diet: low calorie content associated with reduced insulin stimulation.

At the end of the attack phase, the preserved lean body mass, which is guaranteed by the optimal protein supply during the phase of weight loss, and the progressive increase in calories, with foods that have a low glycaemic load, in each of the four steps of the transition phase,enable metabolism to return to appropriate levels.

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References

Documents

The S.D.M. Dietary Protocol · 6 The method THE METHOD T he S.D.M. protocolconsists of a normo-protein Very Low Ketogenic Diet (VLCKD < 800 calories)with a low carbohydrate content