Antioxidants: Finding the Right Balance

Today’s consumer is exposed to the term “antioxidants” now more than ever, as the mainstream media has stressed the importance of incorporating antioxidants into the diet. Consumers hear outlets like ABC News and CNN tout blueberries as an excellent antioxidant source and see high profile products, such as Snapple, publicize their antioxidant capacity. Unfortunately, a great deal of misinformation and confusion has been created. Consumers certainly recognize antioxidants as being “good” for them, but their understanding of exactly why and what they do is more limited.

An antioxidant’s job is to inhibit the effects of oxidation. Oxidants, which include free radicals, are toxic byproducts of human cells as they produce energy to perform specific metabolic functions. Oxidants are neutralized or detoxified by naturally occurring antioxidant enzymes—superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (Gpx). Oxidative stress results when there is a disruption in the balance between oxidants and antioxidant enzymes. The daily rigors of life, smoking, pollution, poor eating habits, over-exposure to the sun’s rays and even the aging process, all contribute to oxidation, thereby creating excessive amounts of damaging free radicals.

As Mitchell May, PhD, CEO and founder, Synergy Production Laboratories (SPL), Moab, UT, points out, there is a beneficial effect from some of this oxidation—it destroys harmful bacteria and viruses in our body. If we didn’t have the oxidation process, something like the flu or cold could get out of hand. “It’s about having a balance in the body,” said Dr. May. “Like many things in our modern era, things are out of balance and so we are generating a great deal more free radicals than what is healthy, thereby causing more damage to the mitochondria, accelerated human aging and dangerous mutations to our cells (i.e., diseases such as cancer).” Antioxidants help restore this balance and inhibit cell damage due to oxidative stress.

Market Update

While vitamin C and E are the main players in this market because of their connections with all sorts of health benefits, S.L. Wright IV, CEO and president, The Wright Group, Crowley, LA, noticed there was a sharp decline for both vitamins in 2005. “Demand fell at least 30% in mass channels and prices on synthetic dl-alpha tocopheryl eroded,” said Mr. Wright. “Vitamin C pricing was also near record low levels. These two ingredients represent the core of the antioxidant market, so based on price erosion alone, the category suffered. Beta-carotene, another core product, also faced challenges in the marketplace. On the positive side, lutein, lycopene, green tea extract, alpha lipoic acid and CoQ10 grew substantially.”

Hartley Pond, technical sales manager, Van Drunen Farms/Futureceuticals, Momence, IL, recognized that consumers are starting to look beyond the standard antioxidant vitamins, such as vitamin C and E, and are turning to antioxidants found in brightly pigmented whole fruits and vegetables. Mr. Pond credits books such as The Color Code: A Revolutionary Eating Plan for Optimum Health by Anne Underwood, James A. Joseph and Daniel A. Nadeau, and What Color is Your Diet? by David Heber, as having done a great job educating the public that a wide range of pigments found in fruits and vegetables have high levels of antioxidants, specifically anthocyanins and proanthocyanins.

Although food is the principle manner in which most nutritional antioxidants are consumed, Folker Ruchatz, PhD, business director, Pharma Solutions and Human Nutrition, BASF, Florham Park, NJ, said only one in four Americans are consuming the recommended five to nine servings of fruits and vegetables a day—the recognized level of intake for maintaining good health. The good news is that informed consumers have recognized this inadequacy in their diet and are consuming antioxidants in supplement, beverage and functional food forms.

Antioxidants made from fruits and vegetable-based material has also become a trend. Some of the hot ingredients include grape seed extract, pomegranate and wild berries (i.e., wolf berries and açai berries). Additionally, the use of exotic juices and extracts has been widespread.

Green tea has also become successful as consumers learn more about its potential in reducing the risk of certain types of cancers thanks to EGCG (epigallocatechin gallate), which is an antioxidant polyphenol flavonoid isolated from green tea. As a catechin, it may protect cells and tissues against free radicals in the body.

Other antioxidants that have received a lot of attention over the last year, according to Ginny Bank, vice president of R&D, RFI Ingredients, Blauvelt, NY, are coffee and chocolate (see chocolate sidebar on page 48). “Coffee is the highest antioxidant food that people are actually consuming,” said Ms. Bank. “In fact, a recent report says that most people are getting more of their antioxidants from coffee than anywhere else.”

Ms. Bank also commented that instead of single ingredients, the market is experiencing a trend in combining huge amounts of antioxidant ingredients.

The Issues

As the antioxidant market gets more crowded with new discoveries constantly popping up, there is cause for concern because it seems every antioxidant has been lumped into one huge category, even though most have different functions. According to a recent report released by HealthFocus International, St. Petersburg, FL, it is precisely the one-size-fits-all concept that has been popular in the antioxidant category for several years that needs to be addressed.

HealthFocus’ most recent report says the new marketing trend for the future is “multi-dimensional marketing,” which emphasizes “benefit-based” communications. Additionally, the report underlines the fact that there is no such thing as an average shopper when it comes to the health and nutrition market. “Each shopper has unique needs based on their age, physical condition, lifestyle and other social and cultural factors,” the report said. “Companies need to develop marketing, communication and product strategies that meet these individual needs.”

The take home message for the antioxidant category is not all antioxidants are created equal. As time goes on, the differences between antioxidants will become more apparent to consumers and they will start to purchase these product based on the fact that they suit a particular need, rather than the fact that they are just antioxidants.

Driving home this point was SPL’s Dr. May, who believes many commercialized versions of “antioxidants” really have no viability as antioxidants. “Companies are exploiting the public’s awareness of antioxidants,” he said. “Unfortunately, consumers don’t know how to decipher what is a good one, which products eliminate free radicals and which do not.”

In agreement was Boxin Ou, PhD, vice president, Brunswick Laboratories, LLC, Wareham, MA, who said he senses a “hidden crisis” because the term “antioxidant” is too generic. “Without any specificity, the term ‘antioxidant’ could potentially turn into a ‘pseudo science,’ causing the antioxidant hype, unfortunately, to fade in the future,” he said.

“Manufacturers of nutraceuticals are constantly looking for ‘the next big thing,’” said Sid Hulse, vice president of sales and marketing, Eustis, FL. “Every day, new compounds are touted for their antioxidant properties. What’s often lacking is good science that shows the antioxidant capabilities of these compounds.

Mr. Hulse also pointed out that antioxidants are being added to nutraceutical formulations at levels below what the science proves is effective—relying on “name” rather than the ingredient itself to move consumers to buy. “Honestly, this approach probably hurts the overall market for these ingredients in the long run,” he said.

Another issue is educating consumers so they understand taking a single antioxidant may not immediately make a difference in their health concern. Unfortunately, many consumers want results right away. Andrew Shao, PhD, vice president, scientific & regulatory affairs, Council for Responsible Nutrition (CRN), Washington, DC, says antioxidants represent a conservative approach to diet and lifestyle and that they don’t work alone. “So to think that a single nutrient is going to make a tremendous impact on overall health is too high of an expectation,” he said. “In most cases, your expectations need to be tempered—you need to take a multi-faceted approach. One antioxidant is just one tool.” Dr. Shao believes healthy adults should be aware that it takes a long-term commitment to benefit from antioxidant supplementation.

The ORAC Debate

The debate over antioxidant testing is still going strong, with people continuing to take sides on the ORAC (Oxygen Radical Absorbance Capacity) testing issue. ORAC has become an industry standard for measuring antioxidant capacity of both water-soluble and oil-soluble products, and many people find value in using this methodology to assess relative efficacy of antioxidants.

“So far, ORAC is the only method in determining antioxidant capacity based on hydrogen atom transfer (HAT) principle, which is the major mechanism for reaction between antioxidants and free radicals,” said Brunswick Laboratories’ Dr. Ou. “The current ORAC assays cover hydrophilic and lipophilc antioxidant capacities. Recently, we added more assays to the ORAC family. For instance, SORAC measures antioxidant capacity against super oxide anion; HORAC and NORAC measure antioxidant capacities against hydroxyl radicals and peroxynitrile, respectively. In addition, we invented the ORAC emulsion, which can be used for cosmeceuticals and dairy products. Meanwhile, we extended the ORAC-lipo assay to extremely oily samples, such as fish oils, plant oils, etc. The new version is called ORAC oil. We are currently working on the assay for antioxidant capacity against singlet oxygen. In the end, the ORAC family will provide a full spectrum of antioxidant measurement.”

Vandrunen’s Mr. Pond says the fact that ORAC’s being used in published papers to denote the antioxidant value of an individual fruit or vegetable by the researchers shows it’s an important assay in ongoing research. “Brunswick Labs has done a great job of coming up with hydrophilic and lipophilic testing and ORAC assays that score individual free radicals. I think antioxidant testing has become more specialized in terms of determining the capacity of individual products,” he said. Van Drunen currently uses ORAC in conjunction with other assays to provide a well-rounded profile of a product.

RFI’s Ms. Bank believes that ORAC is still the preferred method simply because it has so much momentum. In fact, the industry has submitted an ORAC method to be approved by AOAC International, Gaithersburg, MD, which is the organization whose Official Methods are accepted as the “gold standard” by the industry. “Validation of the method is necessary because the new dietary supplement GMPs will require validated methods for anything on a product specification,” said Ms. Bank. “The ORAC method is currently going through a validation test and will likely be approved within the next year.”

Ms. Bank points out the main frustration with the ORAC method is that companies are not comparing “apples to apples,” making it difficult for companies who have a valid ORAC number on products to compete with other companies that are not substantiating anything on their label. An example would be a label indicating a “super high ORAC” but not stating the actual ORAC number.

Many companies also aren’t doing their “homework” when it comes to ORAC labeling, according to Ms. Bank. “Some companies are comparing their product’s ORAC value to an ORAC value of fruits and vegetables based on data published in 1999,” she said. “Since then it has been updated due to new testing methods—it’s all changed. Yet there are a lot of companies still referring to the old data.”

For example, the old data says a serving of vegetables is 300 to 500 ORAC units, while the new data says it’s 900 ORAC units. This has lead companies to put 900 ORAC units into a product and translate that into three servings of vegetables. This has become a big frustration for competitors that are following the updated data and correctly listing it as only one serving of vegetables.

Another concern is companies using alternative extraction methods to extract the ingredients prior to the ORAC test. “The problem with that is there has to be proof that the solvent they are using doesn’t artificially inflate the ORAC value. The method that was developed by the USDA was very particular in choosing a solvent that doesn’t artificially inflate the ORAC value. So anyone who is using a different solvent really needs to show proof of any artificial inflation,” said Ms. Bank.

SPL’s Dr. May agreed, pointing out that there are many poor antioxidants on the market that have no biological value when ingested. “They are separated with solvents like hexane, which is a pro-oxidant and becomes a free radical itself,” he said.

Despite the ORAC controversey, Mr. Wright still believes it is very useful. “Customers and retailers seem to understand it, which is a high entry barrier for alternative methods to overcome,” he said.

Kenn Israel, director of marketing, Soft Gel Technologies Inc., Los Angeles, CA, however, disagreed. One of his main concerns with ORAC is lack of properly listing ORAC levels and, as Ms. Bank mentioned, companies skewing the results in favor of their ingredients. “I think that in the marketing of ORAC, it is very important that our industry uses credible, honest, ethical, and most important, consistent ways of expressing ORAC value,” he said. “There needs to be some sort of standardization or measure, preferably by serving or by grams to help build confidence that this ORAC measure is something of value to the consumer and that products are comparable with each other.”

WH Leong, vice president, Carotech Inc., Edison, NJ, also agreed one of the problems is that ingredients tested need to be compared with a compound from the same category. “An example is the ORAC value for a water-soluble antioxidant versus ORAC value for lipid-soluble antioxidant. If we carry out an ORAC test for vitamin C (which is a water soluble antioxidant) and tocotrienol (a lipid-soluble antioxidant) in an aqueous system, the vitamin C would obviously have a higher ORAC value because the test was carried out in an aqueous system. Does that mean that vitamin E is less potent than vitamin C? No.”

Dr. May is alsoo reluctant in placing an over emphasis on ORAC as a marketing tool due to its inherent limitations of only showing one particular parameter. “Certainly ORAC has had its great value in that it brought the analytical method, a reliable and reproducible method, to this whole concept of antioxidants,” he said. “However, there has been a great deal of misunderstanding because an ORAC value does not in any way indicate the metabolic or biological value of antioxidants when they are consumed. In other words, will those antioxidants that are indicated as ORAC values be active in a living organism?”

Eric Anderson, P.L. Thomas Co., Morristown, NJ, is also concerned about ORAC’s lack of providing the antioxidant’s function in the body. “It would be a stretch to suggest any relevance on the function of antioxidants in the body,” he said. “It’s a test tube—it’s looking at how much oxygen is absorbed by a particular compound. What does that have to do with the function of the antioxidant in the human system? It’s a number that allows marketers to say they have this capacity in a test tube in a fixed environment.”

Mr. Anderson went on to say that the only measurement of antioxidant benefits should be human clinical studies supported by animal studies. “If you can’t demonstrate with clinical studies the benefits of an antioxidant for a specific user need, then I don’t think you have gone far enough down the road in terms of substantiating that product’s efficacy,” he said.

Antioxidant Innovations

While most antioxidants on the market are derived from dietary sources, P.L. Thomas is promoting a way to better aid our internal antioxidant defense system. This is primarily made up of enzymatic antioxidants—SOD, CAT and Gpx—that the body produces in virtually every cell. When cells metabolize oxygen, they steal electrons, creating damaged and out of balance molecules—free radicals. If the free radical isn’t broken down, it can cause damage to the cell and to the cellular DNA of the cell. SOD is considered the most powerful of these enzymatic antioxidants that break down free radicals.

Recently, a French group, Isocell, discovered a way to deliver SOD orally through a product called GliSODin.

According to Mr. Anderson, GliSODin combines gliadin (a wheat protein extract) with a 100% vegetarian form of SOD, which comes from cantaloupe melon. While it’s true SOD is found in many fruits and vegetables, the problem is that when consumed, the stomach acids break down the enzymes in the SOD and destroy them. On the other hand, the cantaloupe SOD found in GliSODin is coated with the wheat protein to protect it against intestinal digestive enzymes and stomach acids, so it can be effectively used in a variety of antioxidant defense and immune support formulations.

In response to the increased interest the antioxidant properties of berries, SPL now offers a berry blend that is certified organic, wild and freeze dried to preserve its antioxidant properties. This new antioxidant product, BerryPower, is being launched this month. The company also supplies vitamin C extract made from wild-crafted camu camu, as well as organic ingredientslike amla berry concentrates with organic acerola, and a proprietary blend of bioflavonoid-rich organic raspberries, blueberries and buckwheat berry sprouts.

In 2004, Valensa introduced its Cranberol line of cranberry seed extracts. “Recent work with cranberries has shown that the most exciting potential for this berry may not be in the fruit, but in the seeds,” said Mr. Hulse. Cranberry seed oil is an excellent source of antioxidants containing a high level of tocotrienols (alpha, gamma and delta). “Put into perspective, cranberry seed oil contains nearly three times the level of tocotrienols of palm oils and five times the level of wheat germ, which is considered by many to be among the best sources of this important form of vitamin E,” he said.

Valensa’s leading antioxidant ingredient, however, is its Zanthin brand astaxanthin. Astaxanthin, a naturally occurring carotenoid pigment, is a biological antioxidant that exhibits strong free radical scavenging activity and protects against lipid peroxidation and oxidative damage of LDL-cholesterol, cell membranes, cells and tissues. “In 2004, Zanthin astaxanthin received an NDI without objection from the FDA. It is also undergoing approval from the U.K. Food Standards Agency as a non-novel dietary ingredient, which will allow it to be marketed in the 25 member countries of the European Union (EU). This represents the first and only astaxanthin extract to have both of these in place,” said Mr. Hulse.

While most people equate coffee to its beans, it is actually a green fruit that grows on trees, turning red as it ripens. And it is within this fruit that the bean is stored. Unlike cranberries, the most exciting antioxidant potential for coffee is lies not its beans, but in the fruit itself. Whole coffee fruit is loaded with high concentrations of beneficial antioxidants and other nutrients, so Van Drunen has combined the health benefits of coffee and berries into its CoffeeBerry product. In the past, coffee growers were forced to throw away the fruit of the coffee plant because it was too perishable to process. But Van Drunen experimented with the fruit and found a way to dry it, thereby preserving it and still keeping the bean intact inside the fruit.

Antioxidant research was pretty general in the past, but now it is starting to target specific therapies like Alzheimer’s disease, eye health and blood pressure. “It now pays for manufacturers of condition-specific ingredients, many of them antioxidants, to do the science and ramp up the message connected to it,” said Mr. Wright of The Wright Group.

Chrysantis, Inc., West Chicago, IL, is one of those companies that have released ingredients to treat disease-specific conditions like age-related macular degeneration (AMD), which is the leading cause of visual impairment and blindness. Consumers realize that lutein is an important antioxidant in relation to eye health, but they are just starting to become more aware of zeaxanthin. Zeaxanthin is a dietary carotenoid found mostly in the macula, the central part of the retina in the eye that is responsible for most vision. Ball Horticultural Co., which has over 40 years of experience breeding xanthophyll marigold varieties that contain lutein, recently bred marigolds that contain zeaxanthin. In partnership with Ball Horticultural, Chrysantis grows these special marigolds to harvest the carotenoids zeaxanthin and lutein. Made into dietary supplements, these substances can help prevent AMD by keeping these carotenoids at optimal levels in the macula.

NutriScience Innovations, LLC, Fairfield, CT, is also improving eye health through antioxidants. The company has launched OptiLut—a 100% natural lutein ester concentrate. OptiLut is sourced from extracts of marigold and submitted to a special purification process without any chemical transformation, maintaining the properties of lutein esters as found in nature.

NutriScience also supplies SunActive Zn, a highly stable and bioavailable form of zinc oxide, manufactured by Taiyo Kagaku Co., Ltd., Japan. Multiple human studies have demonstrated the protective effect of zinc against free radicals and oxidative stress to the body.

Vitamin E is the generic name for the family of tocopherols and tocotrienols. Carotech’s Tocomin product contains a mixture of tocotrienols and tocopherols extracted and concentrated from palm fruits. More specifically, it provides a full spectrum of vitamin E, consisting predominantly of gamma-tocotrienol, delta-tocotrienol, beta-tocotrienol and alpha-tocotrienol. It also contains other phytonutrients, such as plant squalene, phytosterols, CoQ10 and mixed carotenoids. To obtain optimal antioxidant protection, Mr. Leong believes one should take the full spectrum of vitamin E (tocopherols and tocotrienols) because natural phytonutrients don’t work well in isolation from each other.

OxyPhyte is RFI Ingredients’ line of ORAC-based antioxidant products made from fruits, vegetables, teas and herbs selected specifically for their antioxidant activity. Most recently, the company introduced its AC-11 DNA repair product, which is a water-soluble extract made from cat’s claw standardized to quick acid lactones. Clinical research indicates that the product repairs DNA damage that is caused by free radicals. Although not an antioxidant by definition, it is used to counteract free radical damage, which, when paired with antioxidants, provides double the protection against DNA damage.

Cyvex Nutrition, Irvine, CA, has introduced KriaXanthin, an Antarctic krill oil extract that is a natural source of astaxanthin, in a synergistic combination with vitamins A and E, plus omega 3 fatty acids.

Other new products from Cyvex include PomActiv and PomActiv Forte, which are both pomegranate derivatives. “Pomegranate has moved to the forefront recently,” said Gilbert Gluck, CEO, Cyvex Nutrition. “PomActiv, launched last year, is a patented proprietary pomegranate derivative rich in phenolic compounds. PomActiv Forte is an advanced extract, a potent antioxidant resulting from the synergistic effects of complex punicosides, including punicalagin and free ellagic acid. The synergy of these two types of ellagitannins found only in pomegranate enhances the antioxidant capacity.” Cyvex also recently introduced BroccoPlus, which, says Mr. Gluck, is a distinctive and powerful combination of the best that broccoli sprouts have to offer—glucosinolates and sulforaphane—in one convenient concentrated powder.

Robin Ward, vice president of marketing, Linnea, Inc., Locarno, Switzerland, claims the dietary intake of lignans, a major source of antioxidants, has fallen dramatically. “According to the Framingham study, daily dietary intake of lignans was less than 600 micrograms per day,” he said. “Epidemiological studies suggest this may be too low, especially since its human metabolite enterolactone is strongly associated with lower risk prostate and breast cancers.”

Mr. Ward went into more detail. “In these studies, circulating enterolactone levels above 20 nmols/liter showed a significant risk reduction. However dosing lignans in the diet to raise enterolactone to these levels can present a problem, requiring a daily intake 10-50 mg of lignans. Best sources of dietary lignans include sesame, flax or high lignan supplements.” Mr. Ward said in this regard the lignan hydroxymatairesinol from the Norwegian spruce tree (HMRlignan) is an innovation in dosing lignans, providing an efficient method of significantly raising enterolactone levels. “In human clinical studies, just 10-30 mg were demonstrated to raise enterolactone to a protective level,” he said.

Also important on the antioxidant front are xanthones—polyphenols with chemical configurations that make them very strong antioxidants. “Besides being antioxidants, evidence is growing indicating they react at a cellar level with almost all tissues in the human body,” said Dr. Wayne Geilman, director of product technologies and food science, Pure Fruit Technologies, Provo, UT. “Laboratory tests have shown that extracts containing xanthones have anti-microbial, antiproliferative, apoptic inductive and cytotoxic actions. Other studies show them to be anti-inflammatory, and to be COX-2 inhibitors.” Over 40 types of xanthones are found in the fruit, seeds and peel of the Garcinia mangostana fruit. Pure Fruit Technologies has extracted these xanthones for use in its product Mango•xan. To mask the bitter flavor of xanthones, Mango•xan also contains pure fruit juices.

Other new innovations in the antioxidant market include The Wright Group’s microencapsulated antioxidant line. “These products tend by definition to be highly reactive and unstable,” said Mr. Wright. “We can put them all into usable product forms. Supercoat alpha-lipoic acid has been particularly successful, and we are busy developing other products with similar properties.”

In November last year, BASF launched new vegetarian-grade and allergen-free antioxidants. “These products deliver a number of key benefits for manufacturers and consumers who are concerned about the efficacy of label claims and overall performance of products. They also make it possible for vegetarians and people who require a gluten-free diet to utilize these important nutrients because they are non-animal derived,” said Dr. Ruchatz.

Successful Research

Manual Pavon, general manager, Chrysantis, Inc. would like to see more studies on “antioxidant cocktails” because of the synergistic effects of multiple antioxidants that help neutralize oxidative stress and enhance disease prevention. “People are realizing more often that the body needs a combination of antioxidants because it is very well known that one substance can influence the antioxidant activity of another,” he explained.

One antioxidant combination getting attention is Pycnogenol and CoQ10. Dr. Ronald Watson’s University of Arizona article, “Nutraceutical Synergism: Pycnogenol and Coenzyme Q10 Enhance Cardiovascular Health,” discusses how Japanese researchers investigated the antioxidant effect of both Pycnogenol and CoQ10 for protecting lipids from peroxidation by adenosine diphosphate. Investigators tested the effect of adding a small amount of the hydrophilic antioxidant Pycnogenol to the lipophilic antioxidant CoQ10. The antioxidant effect of both micronutrients together was higher than expected from their respective individual activities, proving that CoQ10 and Pycnogenol cooperate synergistically for maintaining good cardiovascular health.

The antioxidant properties of OptiBerry, InterHealth’s (Benicia, CA) synergistic blend of six standardized, anthocyanin-rich edible berry extracts, have also been evaluated. The product was developed after screening a variety of extract combinations for their antioxidant capacity, cellular uptake, safety and the ability to block undesirable blood vessel growth—a key event in tumor formation.

To evaluate the in vivo antioxidant properties of OptiBerry, animals deficient in vitamin E were exposed to a hyperbaric oxygen (HBO) system to induce oxidation. Glutathione was protected in the lungs and liver of animals fed OptiBerry for eight weeks prior to HBO exposure. In addition, feeding OptiBerry for two weeks before exposure to HBO significantly protected animals against whole-body oxidation compared to animals in the control group. Whole-body oxidation was measured by electron paramagnetic resonance.

To further assess safety, OptiBerry was evaluated in acute oral and dermal tests, as well as in eye and skin irritation tests in animals. The oral and skin LD50 (acute toxicity) values were found to be greater than 5000 mg and 2000 mg per kilogram of body weight, respectively, indicating very low potential for toxicity. No changes in body weight or adverse effects were seen in histopathological evaluation.

Lifeline Therapeutics, Inc., Denver, CO, proved the usefulness of antioxidant enzymes in a recent human study published in Free Radical Biology & Medicine, which indicated Protandim, a patent-pending dietary supplement consisting of five naturally occurring plant ingredients, was able to reduce oxidative stress in men and women. Protandim significantly reduced harmful oxidants by encouraging the body to produce more of its own antioxidant enzymes in order to help regulate a healthy oxidative balance. The study measured the levels of TBARS (thiobarbituric acid reactive substances), harmful substances created when cells are damaged by oxidation, in 29 subjects. After 30 days, people taking Protandim experienced reduced oxidative stress, as demonstrated by reducing the amount of TBARS circulating in the blood by an average of 40%. By 120 days of supplementation, Protandim also significantly increased activity of SOD and CAT antioxidant enzymes by 30% and 54%, respectively.

BASF-sponsored research was also recently published in the American Journal of Clinical Nutrition. The study, titled “Modification of Lymphocyte DNA Damage by Carotenoid Supplementation in Post-menopausal Women,” clearly demonstrated that a combination of carotenoids in dietary supplement form could effectively protect DNA from oxidative stress damage.

In the area of safety, Kaneka Corporation of Japan recently conducted a study on its KanekaQ10 product, which is produced using yeast fermentation technology.

The safety assessment was carried out on healthy Japanese subjects using a double-blind, randomized placebo-controlled study design. Results were published in papers at the Japan Health Medicine Association on November 12, 2005, and will appear in the U.S. academic journal Regulatory Toxicology and Pharmacology. The results showed that KanekaQ10 in healthy subjects was well tolerated in dosages up to 900 mg per day.

Qualified Health Claim Setbacks

FDA acknowledged that qualified health claim (QHC) labeling confuses consumers when it held a public a meeting last November. The positive health benefits of antioxidants continue to create a buzz with consumers, but getting QHCs to back products is presenting a challenge for suppliers like Cognis Nutrition and Health, LaGrange, IL.

In March 2004, Cognis petitioned FDA for a QHC linking consumption of Xangold natural lutein esters to a reduced risk of two major eye diseases: AMD and cataracts, which are the leading causes of visual loss and blindness in those aged 55 and older in the U.S. Carotenoids found in Xangold lutein esters are showing promise to help prevent these diseases. So far, research has shown that lutein and zeaxanthin, the only carotenoids found in the retina of the eye, may act as antioxidants and filters to protect the eye from oxidative damage over a lifetime of exposure to harmful ultraviolet (UV) light. Cognis claims Xangold lutein esters are an excellent, bioavailable source of lutein.

Unfortunately, after six extensions and almost two years, Cognis’ petition was denied this past January. “While Cognis is disappointed, this is not the end of the story. We believe that one day there will be a qualified health claim for Xangold,” said Christine Peggau, marketing manager. “It is important to understand that the FDA reviewed science behind free lutein AND lutein esters AND zeaxanthin—not just Xangold.”

According to Ms. Peggau, in its review of the science presented, “the FDA discounted review papers, animal studies and epidemiological studies, and focused on the clinical studies using standards similar to those used to evaluate pharmaceuticals, not nutritional ingredients. Despite the rigid controls used in the human trials, FDA ultimately decided not to issue a QHC based on its restrictive review of the evidence.”

Cognis is evaluating all options regarding the FDA’s opinion and has made no immediate decisions to resubmit.

“Meanwhile, the burden remains with suppliers and manufacturers to find ways to communicate health benefits clearly and accurately to consumers without the added benefit of a QHC,” said Ms. Peggau. “So, the real losers are consumers because a QHC would have helped them more easily identify effective, safe and affordable products to enhance their eye health.”

Despite its QHC setback, Ms. Peggau believes the demand of natural antioxidants will continue to be strong in the coming years, especially in light of the aging population. As baby boomers turn 60, they are turning to antioxidants to help stop the physical effects of oxidative stress in order to look and stay younger longer. “Antioxidants, taken alone or as a powerful network of nutrients, provide a host of health benefits that contribute to overall healthy aging,” said Ms. Peggau.
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