Clinical Evidence in Up-regulating Mitochondrial Energy ......adverse effects of cancer therapy and restore mitochondrial function. Pathol. Oncol. Res. 11: 139-144 (2005). • Nicolson,

Clinical Evidence in Up-regulating Mitochondrial Energy Production,

Improving Cellular Detoxification and Reducing of Fatigue

Rita Ellithorpe, MD

Tustin Longevity Center

Topics of this presentation

• Cell and mitochondrial membrane damage

• Impact and prevalence of fatigue and energy reduction

• Unique proven solution for fatigue reduction and increased energy – Lipid Replacement Therapy (LRT)

• Clinical study verification of safety and efficacy

• Exciting new patented cardiolipin precursors to LRT

The Basic Unit of Life … The Cell

Cell Membrane

Mitochondria

Nucleus

• Cells make up tissues• Tissues make up organs• Organs make up systems• Systems make up the body

• Healthy cells give rise to a healthy body

Cells

Treat the Cell naturally and you treat the body

Human Cell Schematic

The cell contains all of Life’s processes. Of particular importanceIs the mitochondria, which are the sites of energy production

Human Cell Schematic

Mitochondrial and Cell membranes

LipidLayers

Phospholipids

Phospholipids make upBoth the cell and mitochondrial

membranes

Cell Membrane – the outer covering of the cell

8

Cell and Mitochondrial (MT) Membranes

Healthy cell membrane Damaged cell membrane

Your Body’s Cells are in Constant Danger

10

Cell and Mt membrane damage

• Membrane damage occurs– Through Oxidation – burning or corroding – Causing disruption, breakage of structure– Results in defective or depleted phospholipids

• Causes of membrane damage– Environmental toxins, medications, poor

nutrition, diseases, stress, aging, burns, trauma, surgery, drugs, over exercise and more

11

Cell membrane damage• Mitochondrial damage

– Loss of energy production– Genetic (DNA) mutations– Shutdown of major cell functions– Cell death– Loss of energy to the entire body– Fatigue occurs

• Results– Loss of vital functioning of the cell – Interrupts healthy cell growth– Eventually tissues and organs are damaged– Moderate to severe fatigue– Leads to diseases of aging

• Cancer, heart disease, diabetes, loss of brain function,organ failure, arthritis, chronic fatigue, immune disorders, susceptibility to infections, digestive disorders and many more

What is Causes Damage to Cells? • Aging• Stress• Medications• Toxins• Certain foods• Diet – Excess sugars and carbs• Others

• All the above cause diseases of aging, chronic, illnesses , damage to every organ in the body and reduced quality of life

Loss of Mitochondrial Function

Starts with Fatigue

Fatigue is one of the most common complaints in ambulatory care

• 1159 consecutive patients surveyed in adult primary-care clinics

– Major problem in 24%

– More prevalent in women than in men (28% vs 19%)

– Depression and anxiety were associated with fatigue

– Systemic dysfunction observed

– High prevalence, persistence, and functional consequences of fatigue mandate a search for effective therapy

JAMA 1988 Aug 19;260(7):929-34

15

Economic Impact of Fatigue and Energy Reduction

• Fatigue is a major problem in US workforce

– Of 29,000 employees • 38% experienced “low levels of energy, poor sleep, or a

feeling of fatigue

– Fatigue was more common in women than men, in workers less than 50 years old

– $136 billion/year in health-related lost productivity

– 84% of costs were related to reduced performance while at work, rather than absences.

J. of Occupational & Environmental Med. Jan. 2006

Loss of Mitochondrial Function

Mitochondrial Associated Conditions

• Mitochondrial disease. University Department of Clinical Neurosciences, Lancet. 2006 Jul 1;368(9529):70-82.

• The Role of Impaired Mitochondrial Lipid Oxidation in Obesity. Biol Res Nurs. 2009 Feb 3.

• New insights into structure and function of mitochondria and their role in aging and disease. Dipartimento di Biochimica, Universit� di Bologna, Bologna, Italy. [email protected]

• The role of mitochondria in inherited neurodegenerativediseases. J Neurochem. 2006 Jun;97(6):1659-75.

• Review of the literature on major mental disorders in adult patients with mitochondrial diseases. 107: Psychosomatics. 2006 Jan-Feb;47(1):1-7.


• Mitochondrial Dysfunction and Psychiatric Disorders. Neurochem Res. 2008 Nov 1.

• Mitoenergetic failure in Alzheimers disease. Am J Physiol Cell Physiol. 2007 Jan;292(1):C8-23. Epub 2006 Jun

• Mitochondrial DNA and ageing. 61: Biochim Biophys Acta. 2006 May-Jun:17557(5-6):611-7.

• Epub 2006 Mar 31.Mitochondrial dysfunction in cardiovasculardisease. 237: Free Radic Biol Med. 2005 May 15;38(10):1278-95.

• Mitochondrial function in cardiomyocytes: target for cardioprotection. 76: Curr Opin Anaesthesiol. 2005 Feb;18(1):77-82.


• Expanding insights of mitochondrial dysfunction in Parkinson'sdisease. 83: Nat Rev Neurosci. 2006 Mar;7(3):207-19.

• Alterations of mitochondrial DNA in common diseases and disease states: aging, neurodegeneration, heart failure, diabetes, and cancer. 267: Curr Med Chem. 2005;12(4):429-41.

• Cell biology of cardiac mitochondrial phospholipids. 400: Biochem Cell Biol. 2004 Feb;82(1):99-112.

• Mitochondria-targeting therapeutic strategies for overcoming chemoresistance and progression of cancer. 490: Curr Med Chem. 2003 Dec;10(23):2517-21.

What can be done?Repair with LRT

• Repairs cell membranes– Replaces oxidized (damaged) phospholipids– Improves integrity and function– Normalizes electrical potential (activity)

• Enhances mitochondrial (energy sites of the cell)– Improves function – (recharges the powerhouses)– Repairs DNA breakage – necessary for normal balance

• Improves overall function and health of every cell in the body

• Results in improved health and enhanced quality of life

What is LRT? • A complex proprietary blend of specific

Phospholipids– Good fats that make up cell membranes – Extracted from soy – pure – allergy free

• Probiotics– Friendly bacteria – displace bad bacteria– Aid in normal digestion of food

• Growth media for probiotics– Maintains adequate numbers of probiotics

REPAIR

LRT repairs and rebuilds cell membranes

Result: LRT: Healthy cell structure and function leading to overall health and energy of the body

Damaged cell membranes can be repaired by adding new healthy phospholipids

LRT Preclinical Study

Mitochondrial Function Assay

• A dye (Rhodamine 123) added to blood cells of each subject

• The dye is taken up by the mitochondria– The more dye detected the better the mt function– Direct measure of mitochondrial function and

membrane repair

Rhodamine 123 Dye Mitochondrial Stain

Healthy cell unstained

Damaged cellunstained

Healthy cell stained

Damaged cell stained

The damaged cell takes up less of the dye because the mitochondria are damaged

0

500

1000

1500

2000

2500

3000

3500

Control NT Factor

Control

NT Factor

Effects of Mitochondrial FunctionR

h123

upt

ake

Ref: Seidman, MD. Henry Ford Health System, MI; Anti-Aging Medical News 2001

0

5

10

15

20

25

30

35

40

0 3 6 9 12 15 18

Control

NT Factor

P<.0.002

kHz

dB

Effects of NT Factor on Auditory Threshold Shifts


Effects of LRT mtDNA Deletions

0.001

0.002

0.003

0.004

0.005

0.006

0.007

Brain Auditory Nerve StriaVascularis

ControlNT Factor

Del

eted

mtD

NA

/Tot

al m

tDN

A


NT Factor – Preclinical Results

• Mitochondrial function was increased

• NT Factor preserved against hearing loss

• Mt DNA deletion test was quantitatively lower –reflecting slowing of the biological aging process by 20%


NT Factor Clinical Research Studies

• Purpose

– To determine if NT Factor increases mitochondrial function (integrity)

– To determine if NT Factor decreases fatigue using the Piper Fatigue Survey

Fatigue Survey Measurements

Piper Fatigue Scoring• Behavioral/severity• Affective meaning• Cognitive/mood• Sensory

* Piper BF, et. al. Oncol. Nurs. Forum. 1998.

Effects of LRT on Fatigue Reduction

7.4

4.6

1.5

6.2

3.9

2.1

5.4

3.1

2.0

4.4

3.3

1.91

2

3

4

5

6

7

8

9

10

Day 0 Day 30 Day 60 Day 90

SevereModerateMild

Pipe

r Fat

igue

Sca

le

Fatigue Categories

Agadjanyan M, et al, Nutritional Supplement (NT Factor™) Restores Mitochondrial Function and Reduces Moderately Severe Fatigue in Aged Subjects, Journal of Chronic Fatigue Syndrome 2003 Jan; 11(3):23-36.

Average Percent Increase* in MitochrondrialFunction with NT Factor

23

43 43

05

101520253035404550

30 Days 60 Days 90 Days

Perc

ent i

ncre

ase

Star

ting

Poin

t

* RhodamineDye 123 uptake values

Post Treatment with NT FactorAgadjanyan M, et al, Nutritional Supplement (NT Factor™) Restores Mitochondrial Function and Reduces Moderately Severe

Fatigue in Aged Subjects, Journal of Chronic Fatigue Syndrome 2003 Jan; 11(3):23-36.

Reduction of Fatigue Using LRT in an Additional Clinical Study

7.9

6.1

4.7

123456789

10

Day 0 30 Days 60 Days

Fatig

ue S

ever

ityPi

per F

atig

ue S

cale

Post Treatment with NT Factor

N=34P=0.0001

Ellithorpe RR, Settineri RA, Nicolson GL, Pilot Study: Reduction of Fatigue by Use of a Dietary Supplement Containing

Glycophospholipids, Journal of the American Nutraceutical Association 2003 Winter; 6(1):23-28.

LRT Cuts Biological Age in Half

LRT Reduces Biological Age

• Reversal of Age-related Energy Loss by NT Factor in 70 year Old Population to Levels of 29 year old Control Group within 8 Weeks

Journal of Chronic Fatigue Syndrome Jan; 11(3):23-36 2003Journal of the American Nutraceutical Assoc. 6 (1): 23-38 2003Journal of Celllular Biochemistry. 100: 1352-1369 2007Clinical Expeperimental Metastasis 25: 161-169 2008 Otolaryngology--Head and Neck Surgery Sep; 127(3):138-44 2002

LRTClinical Trials Summary

.

Conditionor Illness

Average Age

Piper Fatigue

Significance

Aged 70 35.5% reduction

P<0.001

Fatigue 50.3 40.5% reduction

P<0.0001

CFS/FMS 44.8 43.1% reduction

P<0.0001

GeneralPopulation

57 37% in one week

P<0.001

38

LRT Safety

• Over 38 million doses to date

• No major adverse events reported

• Minor complaints – upset stomach and loose stools in <1% - Usually resolved within a few days

• No side effects or adverse effects reported in 5 clinical trials

• No reported drug interactions

Publications on LRT• Ellithorpe, R.R., Settineri, R. and Nicolson, G.L. Reduction of fatigue by use of a dietary

supplement containing glycophospholipids. J. Am. Nutraceut. Assoc. 6(1): 23-28 (2003).• Nicolson, G.L. Chronic fatigue, aging, mitochondrial function and nutritional supplements.

Townsend Letter Doctors 240(7): 72-76 (2003).• Nicolson, G.L. Lipid replacement as an adjunct therapy in chronic fatigue, anti-aging and

restoration of mitochondrial function. J. Am. Nutraceut. Assoc. 6(3): 22-28 (2003).• Agadjanyan, M., Vasilevko, V., Ghochikyan, A., Berns, P., Kesslak, P., Settineri, R.A. and

Nicolson, G.L. Nutritional supplement (NT Factor) restores mitochondrial function and reduces moderately severe fatigue in aged subjects. J. Chronic Fatigue Syndr. 11(3): 23-36 (2003).

• Nicolson, G.L. Lipid replacement/antioxidant therapy for anti-aging, fatigue and restoration of mitochondrial function. AgroFood High Tech 16(3): 20-23 (2004).

• Nicolson, G.L. Lipid Replacement/Antioxidant Therapy as an adjunct supplement to reduce the adverse effects of cancer therapy and restore mitochondrial function. Pathol. Oncol. Res. 11: 139-144 (2005).

• Nicolson, G.L. and Ellithrope, R. Lipid replacement and antioxidant nutritional therapy for restoring mitochondrial function and reducing fatigue in chronic fatigue syndrome and other fatiguing illnesses. J. Chronic Fatigue Syndr. 13(1): 57-68 (2006).

• Nicolson, G.L. and Conklin, K.A. Molecular replacement for cancer metabolic and mitochondrial dysfunction, fatigue and the adverse effects of cancer therapy. Cancer Genomics Proteomics 3: 159-168 (2006).

• Nicolson, G.L. Metabolic syndrome and mitochondrial function: molecular replacement and antioxidant supplements to prevent membrane oxidation and restore mitochondrial function. J. Cell. Biochem. 100: 1352-1369 (2007).

• Nicolson, G.L. Lipid replacement and antioxidant supplements to prevent membrane oxidation and restore mitochondrial function in metabolic syndrome and fatiguing illnesses. Townsend Lett. 286: 112-120 (2007).

• Conklin, K.A. and Nicolson, G.L. Molecular replacement in cancer therapy: reversing cancer metabolic and mitochondrial dysfunction, fatigue and the adverse effects of therapy. Curr. Cancer Therapy Rev. 4: 66-76 (2008).

• Ellithorpe, R., Settineri, R. and Barwick, D.L. Detox outside the box. Living healthier, better and longer with the newest chelation therapy. Sierra Productions, 103 pp. (2008).

• Nicolson, G.L. and Conklin, K.A. Reversing mitochondrial dysfunction, fatigue and the adverse effects of chemotherapy of metastatic disease by Molecular Replacement Therapy. Clin. Exp. Metastasis 25: 161-169 (2008).

Toxic Heavy Metals

• Heavy metals and other toxins– Cause cell membrane damage– Produce production of free

radicals– Cause oxidative stress

Vanlangenakker, N, Curr Mol Med. 2008 May;8(3):207-20 Vanlangenakker, N, Curr Mol Med. 2008 May;8(3):207-20

Oxidative Damage to Cell Membranes

Healthy Membrane Oxidative Stress Damage

Time-Lapse Microphotography of Toxic Effects on Human Cells

Time-Lapse Microphotography of Toxic Effects on Human Cells

Free Radical Oxidative DamageFree Radical Oxidative Damage

Major Toxic Heavy Metals

• Most Severe – Lead - Pb– Cadmium - Cd– Mercury - Hg– Aluminum - Al– Nickel – Ni– Arsenic

There are NO Safe Levels of Heavy Metals

• Low levels are becoming dangerous

• Low levels accumulate

• Low levels become stored

• Low levels become higher

• Multiple toxins compound the danger

Global Chronic Low Level Metal Toxicity

• Recognized by:– US Environmental Protection Agency (EPA)– Food & Drug Administration (FDA)– Centers for Disease Control (CDC)– State Health Departments

• Treatment standards are needed– Preventative measures– Comprehensive medicine with proven results– Reduction of crisis management

Death Rates of Participants with Low Pb Levels in NHANES III

Survey

39

17

4646

68

0

10

20

30

40

50

60

70

80

10 20 30

All CausesCardiovascular Diseases Cancer

Per

cent

Incr

ease

in M

orta

lity

Per

cent

Incr

ease

in M

orta

lity

Ref: Lustberg, Mark and Silbergeld, Ellen. Blood lead levels and mortality. Arch Intern Med, 2002, 162: 2443-2449Ref: Lustberg, Mark and Silbergeld, Ellen. Blood lead levels and mortality. Arch Intern Med, 2002, 162: 2443-2449

Blood Lead Levels (µg/dL)Blood Lead Levels (µg/dL)

Random Blood Sampling of Dr. Ellithorpe’s Patients: Presence Excessively High Heavy Metals

Per

cent

of P

atie

nts

Per

cent

of P

atie

nts

N=251N=251100

2217

0

25

50

75

100Presence of Heavy MetalsElevated Heavy MetalsPotentially Toxic Heavy Metals

48

Sources of Toxic Metals Aluminum

Source: Agency for Toxic Substances & Disease Registry

• Aluminum cookware • Aluminum foil• Antacids• Antiperspirant• Baking powder

(aluminum containing• Buffered aspirin• Canned acidic foods• Food additive• Lipstick• Medications and drugs

(anti-diarrheal agents, hemorrhoid medications, vaginal douches)

• Aluminum cookware • Aluminum foil• Antacids• Antiperspirant• Baking powder

(aluminum containing• Buffered aspirin• Canned acidic foods• Food additive• Lipstick• Medications and drugs

(anti-diarrheal agents, hemorrhoid medications, vaginal douches)

• Medications and drugs (anti-diarrheal agents, hemorrhoid medications, vaginal douches)

• Processed cheese• “Softened" water• Tap water

• Medications and drugs (anti-diarrheal agents, hemorrhoid medications, vaginal douches)

• Processed cheese• “Softened" water• Tap water

Health Conditions Associated with Aluminum

• Respiratory problems– Coughing– Asthma

• Alzheimer’s disease• Bone disease• Skeletal problems• Skin rashes• Neurological development in children


Sources of Toxic Metal-Arsenic

Source: Agency for Toxic Substances & Disease RegistrySource: Agency for Toxic Substances & Disease Registry

• Air pollution

• Antibiotics given to commercial livestock

• Certain marine plants

• Chemical processing

• Coal-fired power plants

• Defoliants

• Drinking water

• Drying agents for cotton

• Fish

• Air pollution

• Antibiotics given to commercial livestock

• Certain marine plants

• Chemical processing

• Coal-fired power plants

• Defoliants

• Drinking water

• Drying agents for cotton

• Fish

• Herbicides

• Insecticides

• Meats (from commercially raised poultry and cattle)

• Metal ore smelting

• Pesticides

• Seafood (fish, mussels, oysters)

• Specialty glass

• Wood preservatives.

• Herbicides

• Insecticides

• Meats (from commercially raised poultry and cattle)

• Metal ore smelting

• Pesticides

• Seafood (fish, mussels, oysters)

• Specialty glass

• Wood preservatives.

Fluoridation and ArsenicThe Hazards Behind the Faucet

• Arsenic now classified as a Class 1 human carcinogen

• EPA has proposed reducing minimum level from 50 ppb to 5 ppb.

Recent epidemiological work from Finland

Health Conditions Associated with Heavy Metal Toxicity – Arsenic (Cont’d)

• Inorganic arsenic can increase the risk of*:– Lung cancer– Skin cancer– Bladder cancer– Liver cancer– Kidney cancer– Prostate cancer

Source: Agency for Toxic Substances & Disease Registry*Source: WHO, DHHS, EPA

Health Conditions Associated with Heavy Metal Toxicity - Arsenic

• Sore throats• Lung irritation• Nausea & vomiting• Low red & white blood cell count• Abnormal heart rhythm• Damage to blood vessels• Sensation of pins & needles • Darkening of skin• Appearance of small corns or warts


Sources of Toxic Metals-Cadmium


• Air pollution

• Art supplies

• Bone meal

• cigarette smoke

• Food (coffee, fruits, grains, and vegetables grown in cadmium-laden soil)

• Meats [kidneys, liver, poultry] or refined foods)

• Freshwater fish

• Fungicides

• Highway dusts

• Incinerators

• Mining

• Air pollution

• Art supplies

• Bone meal

• cigarette smoke

• Food (coffee, fruits, grains, and vegetables grown in cadmium-laden soil)

• Meats [kidneys, liver, poultry] or refined foods)

• Freshwater fish

• Fungicides

• Highway dusts

• Incinerators

• Mining

• Nickel-cadmium batteries

• Oxide dusts

• Paints

• Phosphate fertilizers

• Power plants

• Seafood (crab, flounder, mussels, oysters, scallops)

• Sewage sludge

• “Softened" water

• Smelting plants

• Tobacco and tobacco smoke

• Welding fumes

• Nickel-cadmium batteries

• Oxide dusts

• Paints

• Phosphate fertilizers

• Power plants

• Seafood (crab, flounder, mussels, oysters, scallops)

• Sewage sludge

• “Softened" water

• Smelting plants

• Tobacco and tobacco smoke

• Welding fumes

Health Conditions Associated with Heavy Metal Toxicity - Cadmium

• Vomiting• Diarrhea• Kidney disease• Fragile bones• Carcinogenic

Source: Agency for Toxic Substances & Disease Registry*Source: DHHS

Sources of Toxic Metals-Mercury

Source: Agency for Toxic Substance & Disease Registry

• Air pollution

• Batteries

• Cosmetics

• Dental amalgams

• Diuretics (mercurial)

• Electrical devices and relays

• Explosives

• Foods (grains)

• Fungicides

• Fluorescent lights

• Air pollution

• Batteries

• Cosmetics

• Dental amalgams

• Diuretics (mercurial)

• Electrical devices and relays

• Explosives

• Foods (grains)

• Fungicides

• Fluorescent lights

• Freshwater fish (especially large bass, pike, and trout)

• Insecticides

• Mining

• Paints

• Pesticides

• Petroleum products

• Saltwater fish (especially large halibut, shrimp, snapper, and swordfish), shellfish

• Tap water

• Freshwater fish (especially large bass, pike, and trout)

• Insecticides

• Mining

• Paints

• Pesticides

• Petroleum products

• Saltwater fish (especially large halibut, shrimp, snapper, and swordfish), shellfish

• Tap water

Facts About Mercury Toxicity

• Mercury Vapor– Most toxic

• 100% absorbed at low dose• 74% absorbed at higher levels

– Accumulates in critical organs*• Brain• Kidney• Transfers across the placental membrane into

the fetus*Vimy M. Hahn LJ. Klober R. Takahashi Y. Lorscheider FL. Mercury uptake in sheep fetus from dental fillings, 32nd Annual Meeting of the Canadian Federation of Biological Societies 14-17 June 1989 and 2nd Meeting of the International Society for Trace Element Research in Humans 8/89

*Clarkson TW, Magos L, Greenwood MR: The transport of elemental mercury into fetal tissues. Biol Neonate 21:239-44, 1972

Aluminum – Links to Alzheimer’s Disease (AD)

• Environmental aluminum is linked to increased rates of AD– Seven studies have related elevated aluminum

concentrations in drinking water to an increased incidence of AD

• Case control study - association of AD and lifetime exposure to aluminum in antiperspirants and antacids. – The more antiperspirant that was used, the more likely the

person would develop AD – The same held true for aluminum antacids. – The risk in high users was as high as 300%.

American Journal of Epidemiology 2000;152:59-66

Sources of Toxic Metals-Lead

Source: Agency for Toxic Substance & Disease Registry

• Air pollution• Ammunition (shot and bullets)• Bathtubs (cast iron, porcelain,

steel)• Batteries• Canned foods• Ceramics• Chemical fertilizers• Cosmetics• Dolomite• Dust• Foods grown around industrial

areas• Gasoline• Hair dyes and rinses

• Air pollution• Ammunition (shot and bullets)• Bathtubs (cast iron, porcelain,

steel)• Batteries• Canned foods• Ceramics• Chemical fertilizers• Cosmetics• Dolomite• Dust• Foods grown around industrial

areas• Gasoline• Hair dyes and rinses

• Leaded glass• Newsprint and colored

advertisements• Paints• Pesticides• Pewter• Pottery• Rubber toys• Soft coal• Soil• Solder• Tap water• Tobacco smoke• Vinyl 'mini-blinds'

• Leaded glass• Newsprint and colored

advertisements• Paints• Pesticides• Pewter• Pottery• Rubber toys• Soft coal• Soil• Solder• Tap water• Tobacco smoke• Vinyl 'mini-blinds'

Health Conditions Associated with Heavy Metal Toxicity - Lead

• Central nervous system• Kidneys• Reproductive system• Decrease reaction time• Weakness in fingers, wrists, ankles• Memory• Anemia• Carcinogenic


Health Conditions Associated with Lead (Cont’d)

• Children are more vulnerable– Blood anemia– Severe stomachache– Muscle weakness– Brain damage– Mental and physical growth


Health Conditions Associated with Lead (Cont’d)

• Younger or unborn children– Premature births– Smaller babies– Decreased mental ability in infant– Learning difficulties– Reduced growth


Health Conditions Associated with Heavy Metal Toxicity - Nickel


• Appliances• Buttons• Ceramics• Cocoa• Cold-wave hair permanent• Cooking utensils• Cosmetics• Coins• Dental materials• Food (chocolate, hydrogenated oils, nuts,

food grown near industrial areas)• Hair spray• Zippers

• Appliances• Buttons• Ceramics• Cocoa• Cold-wave hair permanent• Cooking utensils• Cosmetics• Coins• Dental materials• Food (chocolate, hydrogenated oils, nuts,

food grown near industrial areas)• Hair spray• Zippers

• Industrial waste• Jewelry• Medical implants• Metal refineries• Metal tools• Nickel-cadmium batteries• Orthodontic appliances• Shampoo• Solid-waste incinerators• Stainless steel kitchen utensils• Tap water• Tobacco and tobacco smoke• Water faucets and pipes

• Industrial waste• Jewelry• Medical implants• Metal refineries• Metal tools• Nickel-cadmium batteries• Orthodontic appliances• Shampoo• Solid-waste incinerators• Stainless steel kitchen utensils• Tap water• Tobacco and tobacco smoke• Water faucets and pipes

64

Health Conditions Associate with Nickel

• Apathy• Blue-colored lips• Cancer • Contact dermatitis• Diarrhea• Fever, Headaches• Dizziness• Gingivitis

InsomniaNauseaRapid Heart rate Skin rashes Shortness of

breath Stomatitis Vomiting

InsomniaNauseaRapid Heart rate Skin rashes Shortness of

breath Stomatitis Vomiting

Cancers Associated with Heavy Metals

Toxic Metal Type of CancerArsenic Skin, Lung, Bladder, Kidney, Liver, ProstateMercury Liver, Esophageal, Lung, ProstateAluminum Bladder, Kidney, BrainNickel Lung, nasalCadmium ProstateUranium LungTungsten LungAntimony LungBeryllium Lung

What can we do about Toxins?

• Remove Toxins• Repair Damaged Cells• Revitalize Your Health

Detoxification

• EDTA FDA approved for lead removal • Also chelates other metals

– Suppository form - CaNa2 EDTA (Detoxamin)

• Can be used in combination with IV, oral or as stand alone therapy

– EDTA IV chelation• Expensive• Time consuming – 3-5 hours• Invasive• Greater risk

An Important Major Research Discovery

• “Ninety Percent Reduction in Cancer Mortality after Chelation Therapy with EDTA”

– Blumer, W., Cranton, E. “Textbook on EDTA Chelation Therapy, 2nd ed. Ch, 12, Pp. 185-201

CaNa2 EDTA Suppository Bioavailability

*Blood - tissue ratio*Blood - tissue ratio

Effects CaNa2 EDTA Suppositories on Elevated Lead Urine Levels in Children

4.2

61.45

9

22.7

0

20

40

60

80

100

0 1 10 20 30

Pre-Treatment Baseline After 1st Suppository 10 Days of Suppository 10 Days After Suppository 10 Days Additional Suppository

325.6325.6

µg/d

Lµg

/dL

Treatment DayTreatment Day

N=20N=20

Treatment with CaNa2 Suppositories Chronic Prostate Pain Symptom Scores

0

1

2

3

4

5

6

7

Urinary Symptoms Pain Symptoms QOL Score

Pre Treatment

Post Treatment

*P<0.05

** ** **

Treatment with CaNa2 Suppositories Chronic Prostate Pain Symptom - Total Scores

0

2

4

6

8

10

12

Total Mean Score

Pre Treatment

Post Treatment

*P<0.05**

Treatment with CaNa2 Suppositories International Prostate Symptom Score

(IPSS) Results

0

1

2

3

4

IncompleteEmptying

Frequency Intermittency Urgency Weak Stream Straining Nocturia QOL Score

Pre Mean

Post Mean

*P<0.05

**

**

**

**

**

Treatment with CaNa2 Suppositories International Total Prostate Symptom

Score (IPSS) Results

024

68

101214

Total Mean Score

Pre Treatment

Post Treatment

*P<0.05

**

Practical Clinical Case StudyUsing CaNa2 EDTA Suppositories


42 y/o • W • F • 145 lbs. • Photographer • Fibromyalgia • Chronic Fatigue • Hypothyroid

Outcome: 11/04 – Energy good • Exercises daily (45 min.) with mild to moderate pain of fibromyalgia • Increased daily activities

Date Ar Cd Pb Hg Ni

8/02 220 2.5 20 24 49

12/02 4.5 2.1 7.4 15 25

5/03 45 3.2 12 8.9 18

F.K.


Date Cd Hg Pb Ni

5/03 1.7 30 43 9.5

2/04 1.0 2.6 27 17

2/05 1.0 18 27 13

55 y/o • W • F • 131 lbs. • School Teacher • Chronic LBP • Fatigue • Hypothyroid

Outcome: 7/04 – Excellent energy • Exercise 3x/day – water aerobics • Back pain stable • Reduced need for medications.

Patient K.M.


Date Cd Hg Pb Ni

10/02 1.2 5.2 27 8.4

2/03 0.9 4.4 18 3.6

10/03 1.4 9.8 20 1.6

5/04 0.7 3.8 16 7.7

12/04 1.0 1.6 12 12

52 y/o • M • 175 lbs. • Electrician • Chronic Anxiety Panic Attacks • Hypertension • LBP

Outcome: 10/04 – Anxiety greatly improved • Reduced need for auxiolytic medication • Improved BP • Reduced anti-hypertensive medication • LBP improved • Exercises daily (30 min.)

Patient M.O.

Before Treatment

After Treatment with 60 Detoxamin Suppositories

Comparison of IV Chelation and CaNa2 EDTA Suppositories

IV Chelation

RectalSuppositories

Non-Invasive No Yes

Quick and easy to use No Yes

Inexpensive No Yes

Increased safety No Yes

Broad spectrum metal removal Yes Yes

FDA approved Yes Yes

Clinically proven Yes Yes

• 9 years +, 4000 patients, over 400,000 doses of Detoxamin

– Results in General• Improved mental clarity• Increased energy• Increased endurance• Reduced blood pressure• Enhanced cardiovascular performance• Improved libido and erectile function and prostate

conditions• Improved overall quality of life

Detoxamin Suppositories and Vital Cellular Nutrition

Dr. Ellithorpe’s Clinical Safety Experience with CaNa2 EDTA Suppositories

The Three R’s of Health

• Remove Toxins– Detoxamin chelation suppositories

• Repair Cell Membranes– Vital Cellular Nutrition with NT Factor

• Revitalize cellular & systemic health– Enzymes and Antioxidants

Glycophospholipid Supplements with NT Factor (LRT)

• Complete nutritional formula– Vitamins– Minerals– Antioxidants– Essential fatty acids– LRT– the key to healthy cell function

• Phospholipids (lipids of cell membranes)• Probiotics (good bacteria for intestinal health)

TLC’s Foundation Recommendations

• Supplement your diet– Vital Cellular Nutrition with NT Factor

• Repairs and rebuilds cell membranes• Increases energy• Provides long term protection

– Enzymes• Support mostly all metabolic processes• Aids in digestion

– Antioxidants• Freeze-dried fruits and vegetables • Reduces oxidative stress and free radical damage

Begin with Positive Lifestyle Changes

• Manage stress– Don’t take on more than

you can handle

• Get enough sleep– 8 is the magic number

• Eat a balanced diet– Plenty of unsprayed fruits,

vegetables and whole grains

• Reduce carbohydrates

Positive Lifestyle Changes (Cont’d)

• Drink non-fluoridated, non-chlorinated water– Half your weight in

pounds as ounces

• Exercise on a regular basis– Even if it’s just walking

for 30 minutes a day

For More information

Bob Settineri, Co-Investigator

(949) 474-0667

[email protected]

Clinical Evidence in Up-regulating Mitochondrial Energy Production, Improving Cellular Detoxification and Reducing of Fatigue

Speaker: Rita Ellithorpe, MD

The following potential conflict of interest relationships are germane to my presentation:

Company Name: World Health Products, LLCSpeakers Bureau: NoneStock Shareholder: No

Grant/Research Support: World Health Products, LLCConsultant: Rita Ellithorpe, MD

Status of FDA devices used for the material being presentedEnter Device Name: NA

Status of off-label use of devices, drugs or other materials that constitute the subject of this presentation: CaNa2 EDTA

Documents

Clinical Evidence in Up-regulating Mitochondrial Energy ......adverse effects of cancer therapy and restore mitochondrial function. Pathol. Oncol. Res. 11: 139-144 (2005). • Nicolson,