The Prepared Foods' 2005 R&D Trends Survey: Functional Foods and Beverages makes it plausible to believe that Western culture may transition to eating foods that support disease prevention as doctors have suggested for years. Evidence of the efficacy of functional foods certainly did cause Aaron Tabor, MD, to switch directions.

Tabor, a young medical student in 1997, did not likely think that menopause would ignite a career detour from reconstructive cranial facial surgery into functional food processing. Nevertheless, the post-menopausal irritations his mother experienced led him to create shakes and bars for her--based on the knowledge that protein and isoflavones from soybeans would relieve her symptoms. His recipes caught on with family and friends and, in April 1998, led to the development of Revival Soy (Kernersville, N.C.), the manufacturing company of which he is CEO and medical research director.

"I've been able to help hundreds of thousands of people now, a lot more than if I had been a practicing physician," observes Tabor. "I've been able to feed my medical curiosity through the 22 clinical trials in which Revival Soy products have been or currently are used."

The transition from a conceptually beneficial ingredient to a functional food was not difficult for Tabor. However, those surveyed in PF's study believe there is a lot of ambiguity in the food industry regarding the definition of functional foods. Many Prepared Foods' survey participants defined functional foods as "food that is marketed to provide a specific health benefit" (63%) and "food that is nutritionally beneficial"(53%).

As one participant noted, without FDA regulations to reduce "phony products," consumers become confused about which foods are beneficial to health and which are only marketed that way. Without that clarity, one person noted, consumers may not be willing to pay the price differential.

Some 56% of participant manufacturers characterized their future functional food product development efforts as “brand new products.�

Soy Today, Health Tomorrow

Isoflavones aside, soy ingredients saw heavy rotation during the peak of low-carb popularity. In 2004 when low-carb was hot, 53% of manufacturers predicted an increase in soy protein as a functional food ingredient. Julie Wagner, vice president of research and development at a dairy and nutritional products contract manufacturer, expresses that in 2005 there is "virtually nothing" to anticipate in regards to new low-carb products. Perhaps this explains the significant dip (to 43%) in expected soy protein formulations documented in this year's survey. Even isoflavones dropped in their level of importance from 2004, down to 24% in 2005, according to the survey.

Nonetheless, soy ingredients offer many benefits including cholesterol reduction and they may support a better hormonal balance for older and younger women. Additionally, 55% say products that promote cardiovascular health have a greater opportunity for product development than those that promote other benefits. In 2004, the FDA approved a health claim for a positive correlation between soy protein and lowered risk of coronary heart disease.

“The beneficial effects of soy protein for weight loss are of particular interest to consumers. They are looking to increase protein, but without so much fat,� says Tabor.

Soy products generally have a low-glycemic index, meaning they do not cause the body to over-secrete insulin and, therefore, are optimal for the overweight or diabetic.

Opting Organic

What may be functional is not always organic. Several Revival soy products are organic, but the isoflavones of many products on the market are separated out of soy by a chemical extraction. Also, fat often is chemically removed from soy isolates. Tabor believes the next popular innovation will create an organic way to remove the fat from soy.

According to the Organic Trade Association (OTA, Greenfield, Mass.), approximately 66% of shoppers said they have tried organic foods recently. "People choose organic because they see it as fitting in with a healthy life," says Holly Givens, communications director for the OTA.

One thing is for sure: an organic label is not enough for them to buy it. "It still has to meet their other expectations. It has to taste good to them and be convenient," reminds Givens.

Challenges in developing organic food products range from economics to processing procedures, depending upon the ingredient. Oftentimes, the organic products is a sustainability issue. Some 48% of organic manufacturers surveyed by OTA said a steady, consistent supply of raw materials was imperative to growth. "To me that says instead of rolling a product out nationally, a manufacturer could start smaller," opines Givens.

"For larger companies to become strictly organic would be a major undertaking because of the size and the volume of ingredients that are used and the need to multi-source those ingredients," remarks Wagner.

There are federal restrictions on what ingredients can be added to the 95% ingredients category in products that carry the USDA organic label. For example, some forms of vitamin E are considered to be a synthetic, says Givens. Non-organic ingredients other than water or salt cannot total more than 5% of the finished product by weight. Processors need to be quite familiar with the federal regulations for organic food production and labeling.

All Bets on the Label

"[Manufacturers] are requiring more scientific validation of their ingredients," says Wagner. Her thoughts fall in line with open-ended survey responses that linked the manufacturers' desire to confirm the validity of their health claims to increase consumer confidence. A total of 64% of respondents said it was very important that ingredient suppliers supply regulatory information concerning legality and labeling claims.

"[Creating] a product that consumers can trust and believe in "was listed as a challenge by one survey participant and echoed by many others. Co-branding, a technique to align an unfamiliar product with a product to which consumers are loyal, was ranked "very important"? by only 15% of the surveyed population. However, some do see this as an advantage. "Having our name besides Avon (New York) gave us a lot of credibility and we are looking to do that with other food companies," notes Tabor, who also receives product recommendations from leading health experts like New York Times best selling author and Oprah guest, Christiane Northrup, MD.

Beverages led as the product category that 28% of manufacturers thought would offer their company the greatest opportunity for developing functional foods. “Snacks and health bars" followed, supported by 19.5% of those surveyed. "Bars pretty much exploded in the past five to six years, and they still have some growth left. The nutritionally balanced meal replacement category is also seeing more growth,' observes Wagner

The survey reports that manufacturers feel there is a greater opportunity to utilize dietary fiber for formulations, increasing from 51% in 2004 to 56% this year. Oat fiber seems to be a very popular product, says Wagner. It is important to look at the fiber in conjunction with how it works in a system. "Adding fiber is one thing. Looking at it to perform functionally is another," Wagner explains. "There are a lot of factors that need to be taken into consideration."

"There's a limit to how much you can add and still have a functional product or a nutritionally viable product," says Wagner. "Keep in mind there are other nutrients in that system that are just as important as fiber--if not more so."

Oxy-clean With Lycopene

With 57.3% of the vote, antioxidants remained the ingredient most manufacturers expect to become more important in functional food formulation efforts; slightly fewer (53%) voted the same last year.

Lifestyle habits and normal metabolic processes produce free radicals that are highly reactive with proteins, lipids and DNA. This leads to oxidative stress, which is related to many chronic diseases, including cancer, cardiovascular diseases, osteoporosis and diabetes. Antioxidants prevent oxidative stress on cells and their components (including DNA).

Lycopene, for example, can act as a very potent antioxidant. Venket Rao, professor of nutritional science at the University of Toronto, speculates the FDA will add a health claim for lycopene's positive role in prostate cancer. Lycopene accumulates in the prostate, liver and other organs, where it exhibits its protective properties. Many epidemiological studies "have shown clearly very strong and convincing evidence" that intake of tomatoes and lycopene correlates inversely with the risk of cancer," he says. "They didn't find similar relationships with other green vegetables or with carrots and beta carotene; the more aggressive the cancer, the better the protection that lycopene offers."

According to Rao, a spokesperson for a lycopene supplier, lycopene is three times as potent as beta-carotene and 10 times as potent as vitamin E. The human body cannot synthesize lycopene; hence, it must be obtained through the diet.

Manufacturers did not vary their opinion about the potential for lycopene from 2004 to 2005, as some 33% felt it would become more important to formulations. The carotenoid lycopene is responsible for the red color in tomatoes and has been given GRAS approval by the FDA as a food-coloring agent.

The decreased instances of cardiovascular disease and cancer in populations who eat a Mediterranean diet (which also is high in tomatoes) led to many other observations. "The Mediterranean diet also includes fish, whole grains and olive oil but, we thought, perhaps, tomato and lycopene may be one of the important pieces of the puzzle,"? opines Rao. "Now, we have good data to indicate that lycopene is not only beneficial to reducing prostate cancer, but also breast, cervical, ovarian, lung, colorectal and stomach cancers."

Oxidized DNA causes mutations and increases the risk of cancer; similarly, oxidized LDL is present in the earlier stages of cardiovascular diseases. “You can restrict the progression of cardiovascular disease by increasing the intake of lycopene,� says Rao.

A study involving 10 European countries showed there was an inverse relationship between consumption of tomatoes or lycopene present in adipose tissue, and cardiovascular disease.

Previously, the emphasis of lycopene research has been with male gender diseases. According to Rao, Leticia G. Rao, MD, also a professor at the University of Toronto, is one of the first to conduct a large clinical study examining the relationship of lycopene and osteoporosis in post-menopausal females.

Since lycopene is lipid-soluble, it can be incorporated into products that have a lipid matrix. “Breadsticks, cereals and health drinks are using lycopene,� says Rao. “It seems to act synergistically, in cooperation with other antioxidants like vitamin E and other phytonutrients.�

Stability under high-heat processing conditions and bioavailability are two challenges that continue to plague functional food companies who want to increase the presence of antioxidants in their products. For example, cis-lycopene, formed during heating, is more readily absorbable than trans-lycopene, which is found in all raw tomatoes.

According to Rao's experience in studying lycopene, he recommends a level of 7-8mg of lycopene per day, the equivalent of a can of tomato sauce, soup or juice.

Fellow Functional Friends

Phytoestrogens and phytosterols are generally used in lipid-based products to improve cardiovascular diseases by competing with cholesterol. Lignan, a phytoestrogen present in flaxseed, is among the ingredients that Rao mentions as gaining attention. Flax contains omega-3 fatty acids, an ingredient which also demonstrated a high rank for manufacturers' formulation efforts.

Survey respondents' outlook for calcium shot up to 44% from 37% the previous year. “I think a lot more foods will contain calcium in the near future,� says Tabor. “It's been shown that calcium curbs appetite and reduces symptoms of PMS.�

Benecol (McNeil Nutritionals, Ft. Washington, Pa.) contains plant stanol esters, which are proven to significantly reduce cholesterol by binding in the areas where cholesterol would bind otherwise.

Other healthful agents that compete with cholesterol are soybean-derived saponins, explains Rao. “They are like 'natural detergents.' They bind to cholesterol and prevent the absorption of cholesterol. Also, published data show saponins to be anti-carcinogenic. In fact, many soy-containing consumer products with high isoflavones were analyzed and found to contain almost equal amounts of saponins, says Rao.

Unlike lycopene and beta-carotene, which are fat-soluble, polyphenolic antioxidant compounds such as those found in green tea, red wine and most fruits and vegetables are soluble in water. “Although the emphasis has been on lipid-soluble, humans need a balance between lipid- and water-soluble antioxidants,� says Rao.

For example, lycopene can prevent lipid oxidation, but without water-soluble antioxidants, it is impossible to protect the nucleus of a cell--which is surrounded by water.

The greater manufacturing community is beginning to recognize that foods provide important basic nutrition and contain many functionally important ingredients that play a role in the prevention of disease and management of health, says Rao. “[Even still], we have to be careful that we don't [add] too much of a good thing.� NS