Modern Functional FoodsThe Example ofa Cholesterol-Reducing Margarine

Sala Horowitz, Ph.D.

Hippocrates, said: "Let food beyour medicine and medicine beyour food."1 And a modern

physician, Sheldon S. Hendler, Ph.D.,M.D., associate professor of medicine,University of California, San Diego; chair-person and chief executive officer of theVyrex Corporation, La Jolla, California,and editor in chief of the Journal ofMedici-nal Food, agrees. Dr. Hendler recentlydefined medicinal or functional foods as

"those foods that encompass potentiallyhealthful products, including any modi-fied food or food ingredient that may pro-vide a health benefit beyond thetraditional nutrients it contains."2

Indeed, functional foods, are verymuch in evidence at the brink of the newmillennium. Some food manufacturersadd calcium, vitamin C, or herbs, such as

echinacea, to beverages or frozen treats.Of course, cereals, breads, and pastasenriched with vitamins (to compensatefor eliminating them in the first place byprocessing), or fortified with extra nutri-ents, have been around for decades. Morerecently, such health-promoting foodproducts as soup with St. John's wort tobolster mood and juices fortified withvitamins have become available. Andthere is even a product called BrainGum® (K.R. Research Inc., Reno, Neva-da), which contains phosphatidyl serine(PS), a soybean-derived substance thatmay augment the PS in brain cells thatenables the flow of nerve impulses.

These are examples of the boomingmultibillion-dollar business in what are

variously known as nutraceuticals, func-tional foods, pharmafoods, designer

foods, or therapeutic foods. Some majorfood and pharmaceutical companies now

have entire divisions devoted to function-al foods. Stephen L. DeFelice, M.D.,founder and chairman of the New YorkCity-based Foundation for Innovation inMedicine, coined the term "nutraceutical"in 1989 as a description of any food orfood supplement that is taken for itshealth benefits.3 Richard Firshein, D.O.,author of The Nutraceutical Revolution,defines nutraceuticals as "nutrients thathave the capacity to act like medicines."4For Dr. Barbara Levine, coordinator ofclinical nutrition at the Memorial-SloanKettering Cancer Center, New York City,this trend represents an exciting shift inthinking about what we eat: "While we

used to look at nutritional deficiencies,now, we are looking at the vitamins, min-erals, and phytochemicals in foods thatmay prevent and treat disease," she says.4If this message sounds familiar, it isbecause traditional folk medicine andTraditional Chinese Medicine havealways treated foods as being equal inimportance to drugs with regard to dis-ease prevention and healing.5 Recent gro-cery industry surveys conclude thatconsumers: "would rather get theircholesterol-lowering elements or preventosteoporosis or hypertension throughtasty foods instead of pills."6A Cholesterol-Lowering Margarine

Representative of the new generation offoods augmented with extra nutrientswith purported medicinal properties isthe plant ester-containing margarineBenecol® (U.S. distributor, McNeil Con-sumer Healthcare, Fort Washington,Pennsylvania). This product was

approved in May 1999 after extensive

hearings by the U.S. Food and DrugAdministration (FDA). Since the initialFDA ruling that this product could not bemarketed as a dietary supplement underthe standards of the 1994 Dietary Supple-ment Health Education Act, the companyconvinced the FDA to classify plant estersas a "generally recognized as safe" foodingredient for which specific healthclaims can be made. The "cholesterol-blocking" margarine, first manufacturedby Raisio Inc. (Raisio, Finland), has beenavailable in Finland since 1995—wherethe population, on average, consumes a

diet that is high in saturated fats. Benecolbecame available in the United Kingdomin March 1999. Unlike calcium-enrichedorange juice, the first real functional food,according to nutritionist David Schardt,the popular Finnish anticholesterol mar-

garine has far higher levels of a medici-nal, albeit natural, compound. Themargarine is being marketed as part of atotal dietary approach to reducing choles-terol.7

Finnish Research on the ProductThere is research support for the choles-

terol-reducing claims made for Benecol,which combines unsaturated vegetablecanola oil with sitostanol (stanol ester)—anatural plant alcohol extracted from pinetree oil (a waste product of wood-pulpprocessing). Stanol esters also occur natu-

rally in corn, oats, rye, wheat, and olive oil.Sitostanol is pine-tree oil's hardened fat-soluble form. It can be incorporated intofoods and has a structure that is similar tocholesterol. Sitostanol appears to work bypreventing the intestinal absorption ofextrinsic (dietary) cholesterol and theintrinsic artery-clogging serum cholesterolproduced by the liver.

337

338 ALTERNATIVE & COMPLEMENTARY THERAPIES—DECEMBER 1999

As a rule, a 1 percent drop in cholesterol translatedinto at least a 2 percent reduction in cardiovascular disease.

Major Questions in theDebate on Functional

Foods• What legitimate health claims for foods

can companies make?• Should foods with added nutrients be

regulated as dietary supplements or asfoods?

• Will nutraceuticals, such as Benecol, gainacceptance in the United States as hashappened in parts of Europe?

• What cautions should we heed in addingsuch foods to our diets?

• Will designer foods increasingly becomesubstitutes for foods that naturally pro-vide specific desired nutrients?

• What is the role (if any) of enhancedfoods in supplementing conventional oralternative therapies?

In 1995, The New England Journal ofMedicine reported the findings of a year-long, randomized double-blind studyconducted at the University of Helsinki,Finland. In this study, the daily intake ofthe product was either 1.8 or 2.6 g of theproduct—one serving each at breakfast,lunch, and dinner—without other dietarychanges. Eating the product lowered totalserum cholesterol levels by an average of10 percent and low-density lipoprotein(LDL; "bad cholesterol") levels by 14 per-cent in 51 male and female subjects withmild hypercholesterolemia (defined as

cholesterol levels of 216 mg/dL or high-er). The control group, which consumedmargarine without sitostanol ester,increased their serum cholesterol levelsby a mean of +0.1 percent. The experi-mental margarine did not have any effecton triglycéride or high-density lipopro-tein ("good" cholesterol) levels or on the

absorption of fat-soluble vitamins. Therewere no reported side effects or com-

plaints about the taste. However, a 10-20percent reduction in a particular form ofcarotene was noted.7,8

A more recent Finnish study focusedon postmenopausal women who had hadheart attacks. Of 32 subjects who were

placed on a low-cholesterol diet, abouthalf were randomly assigned to substitutethe sitostanol margarine for 21 g of their36 g total fat diet; the control group con-

sumed regular margarine. After 7 weeks,subjects who ate the Benecol-type mar-

garine had a reduction of 13 percent intotal cholesterol level and a 20 percentdrop in LDL level. Furthermore, the 10subjects who had been taking 10-20 mgper day of a statin-class heart drug inaddition to the special margarine were

able to lower their medication dosage.The researchers concluded that Benecolalone would be sufficient to reduce LDLto desired levels in about one third ofwomen.9 Such results have prompted theAmerican Heart Association to issue a sci-entific advisory statement on the accruingevidence regarding the beneficial effectsof plant esterols on heart disease.10

Benecol in the U.S.:Research and Controversy

As a participant in the first U.S.research on Benecol, the Mayo Clinic(Rochester, Minnesota) studied 300 Amer-icans and found that subjects reducedtheir LDL levels by up to 14 percent byeating Benecol regularly.11 Tu Nguyen,M.D., a Mayo Clinic lipid expert andendocrinologist heading this study'sresearch team, says that "what we hope isthat.

.

.you are going to be able to affectcholesterol levels, to lower them, in a

greater number of patients without hav-ing to go to medications."12 GilbertThompson, professor emeritus of clinicallipidology, Imperial College School ofMedicine, London, concurs: "Benecol willprobably be particularly useful for gener-al practitioners to suggest to healthy peo-ple who have risk factors for coronarydisease, [when] drug therapy is consid-ered inappropriate. [Benecol] offers an

important adjunct in the dietary approachto the primary prevention of coronaryheart disease."13 When asked whethersuch a decline in cholesterol levels is sig-nificant in lowering cardiovascular dis-ease risk, Dr. Nguyen noted that, "as a

rule, a 1 percent drop in cholesterol trans-lated into at least a 2 percent reduction [incardiovascular disease]. ..." He observesthat this sitostanol ester margarine maybe helpful in meeting the American HeartAssociation's guideline of less than 30percent daily fat intake only if the prod-uct replaces, rather than adds to, usual fatintake.14 However, Dean Ornish, M.D.'scardiovascular program at the PreventiveMedicine Research Institute in Sausalito,California, aims for a substantially lowerfat intake of 10 percent. "Loweringcholesterol with functional foods doesn'tmean you can stop exercising, increaseyour calorie intake, or continue smoking,"says Dr. Nyguyen.15

Although Benecol has undergone more

stringent scientific testing than otherfunctional foods and does appear tolower cholesterol levels in patients withslightly elevated cholesterol levels if theproduct is used on a regular basis, TheNew England Journal of Medicine assess-

ment concluded that the studies to datehave been too small to be anything otherthan preliminary. According to an articlein the journal, these study designs did not

ALTERNATIVE & COMPLEMENTARY THERAPIES—DECEMBER 1999 339

It is too soon to tell if consuming stanol ester-containingmargarine will translate into reduced coronary heart disease mortality.

take into account the effects of the greaterintake that people may be tempted to tryin the misguided belief that more is betterfor individuals' overall diets.8 Further-more, it is too soon to tell if consumingstanol ester-containing margarine willtranslate into reduced coronary heart dis-ease mortality.

Bart Duell, M.D., an endocrinologist atOregon Health Sciences University, Port-land, considers Benecol use to be counter-

productive unless consumers cannot giveup regular margarine or butter.16 And,nutrition specialist William Evers, Ph.D.,R.D., of Purdue University, WestLafayette, Indiana, notes that simply eat-

ing products with less saturated fat is a

better alternative. He also worries that themajor ingredient in Benecol might end upin highly processed fatty foods such as

ice-cream.17 There are also concerns thatthe price of Benecol and comparableproducts may be too high for people oflower income brackets and who are atrisk for coronary heart disease.13

Related Dietary IssuesBesides the consensus that the FDA

needs to clarify its position on healthclaims and on labeling dietary supple-ments and food additives, there are validconcerns about safety testing, allegedhealth benefits with little or no researchevidence, and the substitution of pharma-cologically altered foods for alreadynutritious foods such as fruits and vegeta-bles. Digestibility, bioavailability, andinteractions with other nutrients alsoneed to be taken into account.18 Undoubt-edly, many people would agree with thecomment of Joan Gussow, professoremeritus of nutrition and education atColumbia University Teachers College,

New York City: "I want my food to befood," she says.

Tasha Miller, R.D., a dietitian who is a

researcher at Oregon Health Sciences Uni-versity, is similarly concerned aboutdesigned foods with artificial componentssubstituted for more natural ones."Benecol may come across to the averageconsumer as another chance to ignore thebasic necessities of learning to incorporatea moderate diet with more fruits and veg-etables, and regular exercise into theirdaily lifestyle[s]," she says. Marion Nes-tle, chair of the department of nutritionand food studies at New York University,New York City, expresses the concern

"that functional foods will distract peoplefrom eating healthy diets and encourage

of California, San Diego; right: Tasha Miller,

companies to market absurd products as

health foods just because they contain one

or another single nutrient."7 For example,food scientists are starting to modify thenatural potato starch used to stabilizeprocessed food products. In one smallstudy, the effects of two chemically modi-fied potato starches were found to have a

positive effect on plasma glucose andinsulin levels and satiety in healthy nor-

mal-weight subjects. However, the exper-imental starches were eaten in the form ofa 40 percent fat pudding with whippedcream—hardly a health food.19 Moreover,it is not known whether such an engi-neered food would be helpful to patientswith weight or insulin-metabolizationproblems.

Left: Sheldon S. Hendler, Ph.D., M.D. Universit;R.D., Oregon Health Sciences University.

340 ALTERNATIVE & COMPLEMENTARY THERAPIES—DECEMBER 1999

There are no guidelines on the therapeutic"doses" or contraindications for using foods as medicines.

Recommended ReadingBrophy, B., Schardt, D. Functional foods.

Nutr Action Healthletter 26:3-7, 1999.[Cover story by Beth Brophy and DavidSchardt]

The Nutraceutical RevolutionBy Richard Firshein, D.O.New York: Riverhead Books, 1998

Perhaps a preferable strategy may be thedevelopment of commercial foods that con-

tain nutrients that are difficult to obtain inadequate amounts from natural sources. Anexample of a new effort in this area is fructo-oligosaccharides (FOS), fermentable carbo-hydrates that occur naturally in many fruits,vegetables, and grains. To get just one tea-

spoon (4 g) of FOS (with its beneficial effectsof promoting balanced intestinal bacterialflora, reducing free-radical formation, and

increasing vitarnin-B-cornplex production), a

person would have to consume approxi-mately 20 bananas or 380 cloves of garlic!Marjorie Wood, R.D., a dietitian at KaiserPermanante Continuing Care Services inPortland, Oregon, believes that her elderlypatients "could benefit from a fiber-contain-ing formula with FOS to improve bowelfunctioning." FOS-containing food productsare available in Japan and Europe; in theUnited States, FOS has been added to some

medical nutritional preparations.20Unlike what happens when vitamins

and minerals are added to foods, labelingthat discloses the amount added is notrequired for supplemental herbs, aminoacids, or other additives. Moreover, thereare no guidelines on the therapeutic"doses" or contraindications for usingfoods as medicines, unlike what exists forallopathic, naturopathic, and homeopath-ic prescriptions. The Center for Science inthe Public Interest, an advocacy group, isconcerned that consumers will be con-fused or misled by advertising claims andmay consequently reject scientifically sup-ported claims for some nutraceuticals.

On the more positive side, nutrient-enhanced foods mesh well with the trendstoward taking greater responsibility forone's own health, concentrating more on

disease prevention, and being more recep-tive to alternative and complementary ther-apies. According to Dr. Michael Hessman, a

senior research fellow at the Center for FoodPolicy at Thames Valley University, Lon-don, United Kingdom: "Consumers are

looking toward self-medication and forways to enhance their health."6 CyndiThomson, a University of Arizona, Tucson,nutritionist at the American Dietetic Associ-ation concurs that nutraceuticals are a posi-tive approach. "We've always had thisavoidance mentality: 'Don't eat this, don't

ResourcesAmerican Dietetic Association

216 West Jackson BoulevardChicago, IL 60606(312) 899-0040 or (800) 877-1600Web site: www.eatright.org/Founded in 1917, the American Dietetic Association is the largest national group of

food/nutrition professionals. It provides education for both the public and health professionalsand publishes the Journal of the American Dietetic Association. The organization's position onfunctional foods is that they may provide specific health benefits beyond basic nutrition whensuch foods are consumed as part of a varied diet.Food and Drug Administration (FDA)

5600 Fishers LaneRockville, MD 20857(888) INFO-FDA or (888) 463-6332e-mail: webmail@oc.fda.govWeb site: www.fda.govThe FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act and related

public health laws to monitor the safety and effectiveness of foods, cosmetics, medicines,medical devices, pet and farm animal feeds and drugs, and radiation-emitting consumer

products.Center for Science in the Public Interest (CSPI)

1875 Connecticut Avenue, NW, Suite 300Washington, D.C. 20009-5728Phone:(202)332-9110Fax: (202) 265-4954Web site: www.cspinet.orgFounded in 1971, CSPI is an independent not-for-profit consumer health group that is

advocating honest food labeling and advertising and safer food additives, among otherendeavors. The organization publishes the Nutrition Action Healthletter.

ALTERNATIVE & COMPLEMENTARY THERAPIES—DECEMBER 1999 341

"Functional foods are a welcome change becausewe're saying: 'Eat this, eat that, it'll be good for you.'"

eat that.' In a sense, functional foods are a

welcome change because we're saying: 'Eatthis, eat that, it'll be good for you.'"21 Theposition of the Association regarding func-tional foods and phytochemicals is that theymay have a beneficial role in health as partof a varied diet in accordance with the U.S.Department of Agriculture's food guidepyramid.22 This may be welcome news forthe many individuals who eat less than opti-mally healthy diets. For example, fiber-enhanced foods, such as cereals and pasta,make it easier for people to eat the dailyfiber intake of 25-30 g recommended by theNational Cancer Institute, and there is evi-dence supporting the effectiveness of thepsyllium that is typically added in suchfoods.4

ConclusionFunctional foods address the desire to

be more in charge of one's own health viaprevention. While nature still offers theoriginal and best functional foods in natu-rally nutrient-rich fruits and vegetables,the better-tested functional foods, such as

Benecol margarine, may offer a value-added health option to many individualswho eat less than ideal diets or whosebodies do not absorb nutrients optimally.New cholesterol-lowering nutraceuticalversions of such commonly used foodproducts may thus benefit some of theapproximately 98 million Americans withmoderate-to-high cholesterol levels.21 Thecardiovascular benefits of such dietaryand herbal supplements as garlic, Gingkobiloba, and a form of vitamin E have amplybeen demonstrated.23 Nonetheless, manylegitimate concerns have yet to beaddressed regarding the health claims andadequate regulation of that increasinglypopular and lucrative segment of the food

industry that claims to enhance our healththrough specially engineered foods. Asthe lines continue to blur among foods,dietary supplements with health claims,and drugs, it remains to be seen to whatdegree Americans will accept such noveladditions to their diets. D

References1. Smith, E.A. Nutritional products providinghealth benefits: Nutraceutical future looksbright, says panel of experts. Drug Topics142(4):24,1998.2. Hendler, S.S. Medicinal food: The next step[editorial]. J Medicinal Food l(l):l-2,1998.3. Smith, E.A. Industry overview: Nutraceuti-cals market is $86 billion, say experts. DrugTopics 142:59,1998.4. Firshein, R. The Nutraceutical Revolution. NewYork: Riverhead Books, 1998.5. Weijan Weng, Junshi Chen. The Eastern per-spective on functional foods based on Tradi-tional Chinese Medicine [First InternationalConference on East-West Perspectives on

Functional Foods]. Nutr Rev 54(11suppl.):SH-S17,1996.6. Burros, M. Medicated foods raising concernsin many sectors. The Oregonian, September 16,1999, FoodDay, p. 1.7. Brophy, B., Schardt, D. Functional foods.Nutr Action Health Letter 26:3-7,1999.8. Miettinen, T.A., et al. Reduction of serum

cholesterol with sitostanol-ester margarine in a

mildly hypercholesterolemic population. NEngl J Med 333(20):1308-1312,1995.9. Gylling, H. Reduction of serum cholesterolin postmenopausal women with previousmyocardial infarction and cholesterol malab-sorption induced by dietary sitostanol estermargarine. Circulation 96:4226-4331,1997.10. Howard, B.V., Kritchevesky, D. Phytochem-icals and cardiovascular disease: A statementfor healthcare professionals from the AmericanHeart Association. Circulation 95:2591-2593,1997.11. Roan, S. "Functional foods" add extras to

diet. The Oregonian, March 26,1999, p. E5.12. Neergard, L. Cholesterol-reducing mar-

garine will reach stores soon. The Oregonian,July 22,1998, p. B13.13. Mayor, S. Cholesterol lowering margarinelaunched in the United Kingdom. Br Med ]318:960,1999.14. Mayo Clinic Health Oasis Web site:http: / /mayohealth.org /mayo /9803 /htm /belebak.htm15. Mayo Clinic Health Oasis Web site:http ://mayohealth.org/mayo /9901 /htm/ foods.htm16. Rojas-Burke, J. Newfangled foods move

from labs to marketplace. The Oregonian, May26,1999, pp. Cl, C8.17. Purdue University Web site: http://hermes.ecn.purdue.edu:8001/Links/cfs in mg/Q421.html18. Head, R., et al. Functional foods: Approach-es to definition and substantiation [First Inter-national Conference on East-West Perspectiveson Functional Foods]. Nutr Rev 54(11suppl.):S17-S21,1996.19. Raben, A, et al. Acetylation of beta-cyclodextrin addition to potato starch: Benefi-cial effect on glucose metabolism and appetitesensations. Am J Clin Nutr 66(2):304-315,1997.20. Getting enough of a good thing: Fruc-tooligosaccharides (FOS). Part 4. J Am DieteticAssn 98(5)507-508,1998.21. ABC News Web site: http://www.abcnews.aol.com / sections / living /DailyNews /margarine980721.html22. Bloch, A., Thomson, C.A. Position of theAmerican Dietetic Association: Phytochemicalsand functional foods. / Am Dietetic Assn 95:493,1995.23. Horowitz, S. Cardiac health: Nondrugapproaches. ALTERNATIVE & COMPLEMEN-TARY THERAPIES 4:406^10,1998.

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