NUTRACEUTICALS AND FUNCTIONAL FOODS

A recent study in the Journal of the American Dietetic Association indicated that people eating a mixed diet of lower-fat and high-fat foods consume more vitamins and minerals than those who stick to only lower-fat foods or high-fat foods (Sigman-Gran et al., 2003). This study is one example of the essentiality of a variety of fats in the diet.

Researchers from the University of Nevada compared dietary intakes of more than 14,000 American children and adults and divided them into three groups: low-fat eaters (those who ate lower-fat versions of selected foods), high-fat eaters (those who ate “regular” versions of selected foods) and “mixed” eaters (those who ate both lower-fat and regular versions of selected foods). The study findings showed that those who ate a mixed diet had higher intakes of calcium, phosphorus, magnesium, iron, zinc, fiber, most B vitamins, vitamins A and C, and folate.

“This study is a perfect example of how all foods can fit into a healthful eating plan,” said Registered Dietitian and American Dietetic Association (ADA) spokesperson Connie Diekman. “People don’t have to feel guilty about eating their favorite foods, so long as they are eating a balance of foods, as well as getting regular physical activity.”

When it comes to fats, consumers have gone from one extreme to another. The food industry has created fat-free products, followed by low-fat products, and it appears now that full-fat products are back in demand. The message now being conveyed to consumers is that fats are essential to a healthy diet and can actually be good for you, too. True, a high-fat diet is not the way to go, and like any nutrient, the intake amount should be limited. However, research is showing that the choice of fats appears to play an important role as well. And today’s consumers have a variety of healthy fats to choose from, such as oils, phospholipids, and fatty acids. These can now be found fortifying products such as breads, infant formulas, and snacks.

Omega-3 Fatty Acids
The benefits of omega-3 fatty acids for cardiovascular disease have been well documented and studied. This past May, the U.S. Office of Management and Budget (OMB) urged the U.S. Depts. of Health and Human Services (HHS) and Agriculture (USDA) to revise dietary guidelines to reflect information that omega-3 fatty acids may reduce the risk of coronary heart disease (CHD), while trans fatty acids may increase the risk.

The American Heart Association (AHA) also recently revised its own dietary guidelines to recommend the consumption of certain fish that are rich in omega-3 fatty acids. “The American Heart Association applauds OMB for acting to help Americans make more informed nutritional choices,” said Robert O. Bonow, AHA President. “The scientific evidence supporting these changes is substantial, and Americans should have every opportunity to take advantage of this knowledge and take steps that will lead them to healthier lifestyles.”

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In addition, AHA said in a statement that “a dietary approach to increasing omega-3 fatty acid intake is preferable. Still, for patients with coronary artery disease, the dose of omega-3 (about 1 g/day) may be greater than what can readily be achieved through diet alone. These individuals, in consultation with their physician, could consider supplements for CHD risk reduction.”

A report in the November 2002 issue of Circulation recommended that healthy adults eat at least two servings of fish per week, particularly those containing the most potent form of omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (Kris-Etherton et al., 2002). In addition, the authors pointed out that some people need more EPA and DHA than can be readily achieved through diet alone, and in those cases, omega-3 fatty acid supplements should be considered.

The protective effect of omega-3 fatty acids was recently explained in a study published in Circulation (Leaf et al., 2003). Alexander Leaf, Jackson Professor of Clinical Medicine, Emeritus, at Harvard Medical School, Boston, and a team at Harvard Medical School cultured neonatal heart cells from rats and viewed them under a microscope. They found that the cells clumped together and beat simultaneously and rhythmically in the same way as a real heart.

“Animal experiments show that fatty acids from omega-3 fish oils are stored in the cell membranes of heart cells and can prevent sudden cardiac death or fatal arrhythmias,” Leaf said. Arrhythmias are irregular heart rhythms. Leaf said that studies of individual heart cells demonstrated that the omega-3 polyunsaturated fatty acids (PUFAs) specifically blocked excessive sodium and calcium currents in the heart. Those excessive electrical discharges can cause dangerous and erratic changes in heart rhythm. Using a video camera, Leaf and his colleagues taped the action of the cells and the effect of different toxic agents on the cells. They observed that adding omega-3 PUFAs prevented arrhythmias induced in the cells.

According to doctors, at least half of all heart attacks are caused by irregular heartbeats. Leaf said that eating fresh or frozen oily fish is the best way of protecting the heart.

In another study (Thies et al., 2003), a team of researchers from the University Hospital in Southampton, England, treated 188 stroke patients with omega-3 fatty acids and reported a significant reduction in the extent of atherosclerosis. They said that the oils transformed dangerous atherosclerotic plaques into harmless scars.

The patients, divided into three groups taking either omega-3 fish-oil capsules, sunflower-oil capsules, or a placebo six times a day, were treated over an average period of 42 days. Fish oil patients received 1.4 g of omega-3 fatty acids daily.

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The researchers reported that omega-3 fatty acids helped to make scars harmless and stabilize the health in stroke patients who are at high risk of the atherosclerotic plaques rupturing or forming clots. The team added that omega-3 fatty acids can be integrated into the sclerotic areas in the carotid artery. The results can be explained by omega-3’s anti-inflammatory effect.

In addition to heart disease and infant development (see sidebar), omega-3 fatty acids are also being studied for their protective effect on ulcerative colitis. The New Jersey Commission on Science and Technology is currently funding a multidisciplinary project entitled, “Foods Fortified with Omega-3 Fatty Acids: Health Benefits in Ulcerative Colitis.” The team is composed of food technologists, scientists, nutritionists, physicians, and clinical specialists from two institutions: Rutgers University and the University of Medicine and Dentistry of New Jersey (Borneo, 2003).

“Our effort is focused on ulcerative colitis,” said Rafael Borneo, Postdoctoral Associate, Dept. of Food Science at Rutgers University. Ulcerative colitis (UC), he explained, “is a chronic inflammatory bowel disease of the colon characterized by multiple flare-ups. Diarrhea, bleeding, and pain in the rectum are the primary symptoms. Anemia is also common. The disease, as of today, is managed using medications, but not cured. It is estimated that 1 million people in the U.S. suffer from UC. People with UC are also at increased risk of developing colorectal cancer. The etiology of the disease is not well understood and the rate of new incidences of this disease is increasing.”

According to Borneo, several drugs have been used in treating UC, such as sulphasalazine and 5-aminosalicylate. The mechanism of action of these drugs could be through inhibition of cyclooxygenase (COX) activity or reduction of lipoxygenase activity, two key enzymes that mediate the pathway of eicosanoids (Lauritsen et al., 1990). Omega-3 fatty acids, like these drugs, inhibit COX activity (Kalman et al., 1992). “Therefore, we believe that consumption of EPA + DHA fortified foods may be a safe way to manage and improve patients’ health,” Borneo said. “Once our product is formulated it will be used for clinical testing on UC patients.”

Borneo works on the food processing component of this project. “Our objective is to develop foods fortified with omega-3 fatty acids, specifically, EPA and DHA, with acceptable sensory qualities. We are at a very early stage of the project. Preliminary results have shown that in some baked food products the loss of omega-3 fatty acids could be as much as 40%. We believe that the low moisture/high temperature processing conditions are responsible for these significant losses. Novel food ingredients and product development, with minimal processing, are needed to reduce the losses.”

A team of scientists at the Pennsylvania State University, University of Massachusetts, and University of Connecticut are conducting more work with omega-3s and food products. They are looking at fortifying foods such as ice cream, orange juice, salad dressing, and processed meats. Researchers at Harvard University will evaluate the health benefits of whatever products the scientists develop. “Our ultimate goal is just to provide more types of foods that you can get your omega-3s from, and foods where you can’t tell the difference,” said Eric Decker, Professor of Food Science at the University of Massachusetts-Amherst (Lewerenz, 2003). Decker said a trial at the university produced an omega-3-fortified yogurt that tasted like regular yogurt.

In addition to infant formulas, consumers can find omega-3 fatty acids fortifying baked goods, nutrition bars, and eggs. In May, UK-based Warburtons Ltd., introduced Good Health Loaf for Women in the UK. The bread contains the omega-3 fatty acid DHA to boost brain function, folic acid, calcium, and iron. It boasts 30 mg of DHA/100 g of bread. In Canada, nutritional oil company Bioriginal Food & Science introduced an omega-3-rich flax flour, BakOmega, designed to increase the omega-3 content of baked foods. The finely ground flax flour is said to have improved functionality, stability, and taste. The product also contains many vitamins and minerals, fiber, and lignins, thought to help protect against heart disease, high cholesterol, diabetes, osteoporosis, and certain types of cancers.

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Gamma Linolenic Acid
Researchers have found that daily doses of a 3-way combination of EPA, DHA, and gamma linolenic acid (GLA) appear to improve cholesterol levels in healthy women and lower their risk of heart attack (Laidlaw and Holub, 2003).

In a 28-day clinical trial, researchers at the University of Guelph, Ontario, Canada, supplemented 31 healthy women with various dosage combinations of fish oil and GLA, which were supplied by UK-based Croda Healthcare. Dosages of 4 g of EPA/DHA and 0–4 g of GLA were administered. A control group was provided with fish oil.

Results indicated that participants supplemented with 4 g of EPA/DHA and 2 g of GLA demonstrated the greatest overall reduction in heart attack risk, with greatly improved blood lipid and fatty acid profiles. Researchers estimated this combination of EPA/DHA/GLA produced a 43% reduction in the 10-year risk of heart attack.

Claire Packer, scientist at Croda Healthcare, commented, “It has been known for some time that EPA/DHA fish oil supplementation in cardiovascular disease is beneficial, however, the science has now moved on with this latest research indicating that the best protection may be achieved by adding plant-derived GLA oil to fish oil.”

Conjugated Linoleic Acid
Conjugated linoleic acid (CLA) has been implicated in weight loss, weight maintenance, and diabetes. In a double-blind, placebo controlled study at the University of Wisconsin Beers-Murphy Clinical Nutrition Center, study subjects who received 6 g of CLA (Clarinol) lost a significant amount of body fat. The group taking CLA also had a significant decrease in adverse effects typically associated with low-calorie diets compared to those in the control group, reported Loders Croklaan, the supplier of Clarinol.

The study involved 60 obese men and women, who were randomly assigned to either the treatment or control group, and were on a low-calorie diet. At the conclusion of the 28-week trial (consisting of a 12-week weight-loss period and a 16-week weight regain period), the CLA group lost more weight overall and regained more lean body mass, the company reported. Also, females in the CLA group lost more total weight and more fat weight. In addition, those in the CLA group reported significantly fewer occurrences of the adverse side effects typically associated with dieting, such as skin rash, irritability, anger, depression, and hair loss. The company presented the research results in April at the Federation of American Societies for Experimental Biology meeting.

An 8-week pilot study at Ohio State University showed that CLA may help diabetics manage their weight and blood sugar level (Belury and Mahon, 2003). Diabetics who added CLA to their diets lowered their body mass as well as blood sugar levels. Weight gain often triggers high blood sugar levels, commonly known as hyperglycemia. Lower blood sugar and body weight levels may help to reduce or stop the onset of this condition, which is a common characteristic of diabetes.

The study also found that an increased level of CLA in the bloodstream produced lower levels of leptin, a hormone produced from fat cells that helps produce a sense of satiety in the brain. Some researchers believe that obesity may trigger a resistance to normal leptin levels, which causes the body to produce more and contributes to increased hunger and a slower metabolism.

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“Prior results using animal models have found that CLA delayed or mitigated the onset of Type 2 diabetes,” said M.A. Belury, senior author of the study. “This current study appears to indicate that CLA can also help to manage adult-onset, or Type-2 diabetes, in humans.”

In the study, 21 individuals diagnosed with Type 2 diabetes consumed either a daily supplement of CLA One® or a safflower-oil placebo for the duration of the 8-week study period. Subjects were not asked to modify their daily caloric intake or exercise levels. Fasting blood glucose levels decreased in 9 of the 11 individuals taking the CLA supplement (81%) but in only 2 of the 10 (20%) taking the placebo. The researchers also studied the impact of CLA on both body mass (weight) and leptin levels and found that the t10, c12 isomer was most likely responsible for reduced body weight and leptin levels. The average weight loss among subjects consuming the CLA supplement was approximately 3.5 lb. The control group neither lost nor gained weight. Leptin levels decreased in the CLA group and rose slightly in the control group.

“The study results are encouraging, especially in light of the current epidemic of both diabetes and obesity among Americans over the past decade,” said Susie Rockway, Director of Scientific Affairs for PharmaNutrients, Inc., Lake Bluff, Ill., the company that supplied CLA One for the study.

A long-term study demonstrated a significant reduction in body fat and increase in lean muscle for those taking a CLA supplement. Cognis was exclusive manufacturer of Tonalin® CLA used in the study. Overweight subjects were randomized in three groups and supplemented for one year, with CLA given as either free fatty acid or triglycerides and compared with a placebo (olive oil). Measurements performed with dual-energy X-ray absorptiometry showed significant changes over time. Possible factors such as diet and training were also analyzed. In addition, the long-term safety of the CLA was confirmed through rigorous recording of any side effects occurring during the overall study and analyses of blood parameters, including blood lipids and diabetes markers. And records of the quality of life were done to evaluate how CLA affected the daily life of the subjects.

The study demonstrated that CLA reduced body fat by 9% and increased lean muscle by 2%. The most remarkable effects on body composition were produced by trials performed with a mixture of the bioactive isomers (cis-9, trans-11, and trans-10, cis-12). Specifically, the CLA generated a significant decrease in body fat, body weight, and body mass index.

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Functional Oil
Forbes Medi-Tech, Vancouver, British Columbia, Canada, holds the patent to a new cooking oil, at present known as Functional Oil. It is a blend of tropical oils, olive oil, coconut oil, and flaxseed oil—fats that are high in medium-chain triglycerides (MCTs). MCTs are thought to be directed to the liver and burned as energy, rather than being stored in the body as fat. They are also thought to increase metabolic rate.

Functional Oil has been tested against conventional cooking oil in clinical trials on overweight subjects at McGill University’s School of Dietetics and Human Nutrition in Montreal, Canada. The volunteers, who were approximately 25 lb overweight, ate a normal “North American” diet during the study, including everything from French toast with maple syrup to spaghetti with meat sauce. Over a 27-day period, male volunteers, despite eating the same quantity of oil as others given conventional cooking oil, lost an average of 1 lb. The women, however, did not lose any weight. The test results suggested, however, that the oil might actually reduce cholesterol levels—by as much as 13%. According to the company, the oil is unlikely to hit supermarket shelves before further tests are carried out.

Fat-Fighting Oil
Archer Daniels Midland Co., Decatur, Ill., launched its Enova cooking oil last year. It is marketed by ADM Kao LLC., a joint venture between ADM and Kao Corp. of Japan, which developed the oil. More than 15 years of research and numerous studies have shown that the oil helps reduce both body weight and fat mass when used as part of sensible diet.

Beginning with all-natural soybean and canola oil, Enova oil is produced from a patented process that increases concentrations of diacylglycerol (DAG), a naturally occurring component found in all vegetable oils. While Enova oil contains the same amount of calories and fat as conventional oils, it is metabolized differently. Because of its chemical structure, more of it is burned directly by the body as energy, rather than stored as fat.

A study completed by the Chicago Center for Clinical Research showed that over a 24-week period, people who incorporated Enova oil into a calorie-controlled diet reduced their weight by an average of 3.6% and their body fat mass by 8.3%.

Sesame Oil
Researchers reported at an Inter-American Society of Hypertension meeting in the U.S. in April that sesame oil was found to reduce high blood pressure and lower the amount of medication needed to control hypertension.

In this study, researchers identified 328 patients (195 men and 133 women, average age 58) who were taking 10–30 mg daily of nifedipine, the calcium channel blocker drug. They had moderate to severe long-term hypertension but no history of heart disease or stroke. Their average blood pressure was 166/101 mm Hg, which is considered stage 2 hypertension.

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Using sesame oil as the sole cooking oil for 60 days along with drug treatment lowered patients’ systolic blood pressure levels from 166 mm Hg to 134 and diastolic from 101 mm Hg to 84.6.

The researchers also reported that the daily dose of nifedipine was reduced from 22.7 mg to 7.45 mg by the end of the study. Participants consumed an average of 35 g of oil per day for 60 days.

“The effect of the oil on blood pressure may be due to polyunsaturated fatty acids and the compound sesamin—a lignan present in sesame oil,” said lead author
Devarajan Sankar, a research scholar at Annamalai University, Chidambaram, Tamil Nadu, India. “Both compounds have been shown to reduce blood pressure in hypertensive rats. Sesame lignans also inhibit the synthesis and absorption of cholesterol in these rats.”

Sesame oil contains 43% polyunsaturated fatty acids and 40 mg of vitamin E/100 g, he said. The research team had previously found that sesame oil helped reduce blood pressure in hypertensive patients taking diuretics or beta blockers, and that it helped people with diabetes regardless of high blood pressure.

Cranberry Oil
A new cranberry oil, Omegacran, was introduced at SupplySide East this past May. The ingredient is produced using a chemical-free, cold press expeller process. The oil provides both omega-3 and omega-6 fatty acids, in an equal ratio. Cranberries have been associated with urinary tract health, and their high antioxidant activity is thought to offer considerable disease-fighting abilities.

Phytosterols
Phytosterols are a group of plant compounds with a chemical structure similar to that of cholesterol. They inhibit absorption of cholesterol in the gut, while not being absorbed themselves in significant amounts.

In 2000, the Food and Drug Administration authorized the use of labeling health claims about the role of plant sterol or plant stanol esters in reducing the risk of CHD for foods containing these substances. Foods that qualified for the health claim based on plant sterol ester content included spreads and salad dressings. Foods that qualified for claims based on plant stanol ester content included spreads, salad dressings, snack bars, and dietary supplements in softgel form.

Foods that carry the claim must also meet the requirements for low saturated fat and low cholesterol, and must also contain no more than 13 g of total fat per serving and per 50 g. However, spreads and salad dressings are not required to meet the limit for total fat per 50 g if the label of the food bears a disclosure statement referring consumers to the Nutrition Facts section of the label for information about fat content. In addition, except for salad dressing and dietary supplements, the food must contain at least 10% of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) for vitamin A, vitamin C, iron, calcium, protein, or fiber.

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Scientific studies show that 1.3 g of plant sterol esters or 3.4 g of plant stanol esters per day in the diet are needed to show a significant cholesterol-lowering effect. To qualify for this health claim, a food must contain at least 0.65 g of plant sterol esters or at least 1.7 g of plant stanol esters per serving. The claim must specify that the daily dietary intake of plant sterol esters or plant stanol esters should be consumed in two servings eaten at different times of the day with other foods.

This past February, FDA expanded the use of the phytosterol heart-health claim to a broader range of food products and dietary supplements. In a letter sent to Cargill Health & Food Technologies, Wayzata, Minn., FDA stated that “Comments and supporting scientific evidence now suggest that currently available scientific support extends to a broader range of phytosterol substances. As you pointed out in your letter, FDA has received notifications regarding Generally Recognized as Safe (GRAS) determinations for various phytosterols used as food ingredients at levels necessary to justify the health claim. The agency has not objected to these notifications.”

FDA went on to say that it “will consider exercising enforcement discretion with regard to the use of a claim about reduced risk of CHD in the labeling of a phytosterol-containing food” if, among other requirements, the food contains at least 400 mg per reference amount customarily consumed (RACC) of phytosterols; mixtures of sterols and stanols contain at least 80% beta-sitosterol, campesterol, stigma-sterol, sitostanol, and campestanol; the claim specifies that the daily dietary intake of phytosterols that may reduce the risk of CHD is 800 mg or more per day, expressed as the weight of free phytosterol; and vegetable oils for home use that exceed the total fat-disqualifying level bear the health claim along with a disclosure statement. More information is available at www.cfsan.fda.gov/~dms/ds-ltr30.html.

Phosphatidylserine
Phosphatidylserine, a phospholipid, has been touted to boost memory and concentration. In February of this year, FDA released a letter regarding a dietary supplement health claim for the relationship between phosphatidylserine and cognitive dysfunction and dementia. The letter was sent to Emord & Associates, P.C., Washington, D.C.

In the letter (see www.cfsan.fda.gov/~dms/ds-ltr33.html), FDA stated that it will consider exercising enforcement discretion with respect to two proposed claims—“Phosphatidylserine may reduce the risk of dementia in the elderly” and “Phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly”—if they are accompanied by the following disclaimer: “Very limited and preliminary scientific research suggests that PS may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim.” The words “cognitive dysfunction” must replace “dementia” when the second claim is used.

In addition, the disclaimer must be placed immediately adjacent to and directly beneath the claims with no intervening material, in the same size, typeface, and contrast as the claim itself.

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Fatty Acids for Infant Health
Docosahexaenoic acid (DHA) and arachidonic acid (ARA) are two fatty acids found in small amounts in breast milk. Numerous studies have implicated that they are important for brain and visual development in infants.

For example, work done at the Retina Foundation of the Southwest, Dallas, Tex., looked at the effects of DHA and ARA on later cognitive development of healthy term infants (Birch et al., 2000). The randomized clinical trial of 56 children 18 months old utilized formula milk supplemented with 0.35% DHA or with 0.36% DHA + 0.72% ARA and a control formula with no DHA or ARA. The infants were enrolled in the trial within the first five days of life and were fed the assigned diet to 17 weeks of age.

Supplementation of infant formula with DHA+ARA was associated with a mean increase of 7 points on the Mental Development Index (MDI). Both the cognitive and motor subscales of the MDI showed a significant developmental age advantage for DHA-supplemented and DHA+ARA–supplemented groups over the control group.

In 2002, several infant formulas containing DHA and ARA hit the market. For example, Ross Products Div. of Abbott Laboratories, Columbus, Ohio, launched Isomil® Advance®, a soy infant formula supplemented with DHA and ARA. “Isomil Advance is made without palm or palm olein oils,” said Russell J. Merritt, Medical Director of Pediatrics and Medical Nutritionals at Ross Products. “Research has shown that formulas made with palm or palm olein oils may provide less calcium absorption than formulas made without those oils.”

Most recently, the company has launched Alimentum® Advance®, a protein hydrolysate formula with iron supplemented with DHA and ARA. It is expected to be available this summer in ready-to-feed form. Alimentum Advance is available for infants and children with severe food allergies and sensitivity to intact protein.

by LINDA MILO OHR
Contributing Editor
Chicago, Ill.

References