Slim Pickings?

When the Food and Drug Administration (FDA; Rockville, MD) announced at the end of 2003 that it was banning ephedra, some thought it spelled the end of the weight-loss product category. However, to misquote Mark Twain, the reports of the category’s death are greatly exaggerated.

While the ban did eliminate a top-selling ingredient, in the long run it may have ended up helping, rather than hurting, the industry. As manufacturers have backed away from stimulant-based approaches to weight loss, other ingredients have rushed in to fill the void. Moreover, manufacturers are now asking for more clinical and safety data.

Jim Komorowski, MS, vice president of technical services and scientific affairs at Nutrition 21 Inc. (Purchase, NY), which supplies Chromax chromium picolinate, notes that the market is still active, as manufacturers are looking for alternatives to ephedra and other stimulants.

“Manufacturers are moving away from stimulants but are open to other approaches,” Komorowski says, adding that they are looking for “ingredients that help with responsible weight loss, not ingredients that send metabolism and heart rate skyrocketing.”

Patrick Luchsinger, marketing manager at Loders Croklaan Lipid Nutrition (Channahon, IL), which supplies Clarinol conjugated linoleic acid (CLA), agrees. “The market for weight-loss and weight-management ingredients is dynamic,” Luchsinger says. “As an ingredient supplier, you have to keep sharp not only on the new research but on consumer trends as well.”

BUILDING LEAN BODY MASS

One of the newest trends for weight-loss products centers on formulas that promote lean muscle mass, rather than those that just burn fat and diminish appetite.

“Lean muscle mass is metabolically more active than fat mass,” explains Luchsinger. “In simple terms, a pound of muscle will burn more calories at rest than a pound of fat. Therefore, the more lean muscle mass you have, the higher your resting metabolic rate.”

“The percentage of lean body mass to fat determines the body’s aesthetic appearance, but more importantly, it is an index of physical fitness, health status, susceptibility to disease, and premature death,” adds Todd Norton, president of Sabinsa Corp. (Piscataway, NJ), which supplies ForsLean, a standardized extract of the herb Coleus forskohlii.

CONJUGATED LINOLEIC ACID

POTATO EXTRACT MAY ASSIST WITH WEIGHT CONTROL

A new extract derived from potatoes may help promote weight loss by creating feelings of fullness and satisfaction during meals.

Satise, a supplement manufactured by Kemin Consumer Care (Des Moines, IA), enhances the release of the hormone cholecystokinin, which causes the stomach to empty more slowly and induces feelings of satiety in the brain. The active ingredient in Satise, proteinase inhibitor II (PI2), is extracted from potatoes using a patented process.

According to Kemin, a person would need to eat about four boiled or baked potatoes to ingest the amount of PI2 in a typical capsule of Satise.

Six clinical studies on PI2 have been published in peer-reviewed journals or presented at scientific meetings. In one double-blind crossover study conducted in 1999 at Columbia University (New York City), researchers found that 30 mg of PI2 administered before a meal resulted in a 30% decrease in hunger ratings.

One popular ingredient for building lean muscle mass is CLA. The term CLA refers to several different isomers of linoleic acid. Two of these isomers, c-9,t-11 and t-10,c-12, have been shown to have beneficial effects on health, including the ability to reduce fat mass and increase lean body mass.

“CLA is traditionally found in beef and dairy products, vegetable oils, and processed foods,” explains Luchsinger. “Cows and other ruminant animals produce CLA naturally from linoleic acid, which is present in their diets.”

One of the first long-term human studies on CLA was published last year in the June issue of the American Journal of Clinical Nutrition. In the double-blind, placebo-controlled study, researchers randomly assigned 180 volunteers with body mass indexes of 25–30 into one of three groups: a CLA free fatty acid group, a CLA tricylglycerol group, or a placebo group. After one year, the researchers measured changes in body fat mass and lean body mass using dual-energy x-ray absorptiometry.

After finding that the volunteers from the first two groups had lower body fat mass and higher lean body mass, the researchers concluded that “long-term supplementation with CLA free fatty acids or CLA tricylglycerols reduces body fat mass in healthy overweight adults.”

“Animal and human studies suggest that CLA has positive effects on the body,” Luchsinger says. “But the levels required to attain these benefits are too large to obtain from a natural diet.”

According to Luchsinger, Clarinol has several advantages over other forms of CLA. “Clarinol is produced through the largest purpose-built manufacturing plant dedicated to CLA production in the world and with the only process that has been proved to give highly concentrated, high-quality CLA time and time again,” Luchsinger says. “This dedicated process is patented by Lipid Nutrition.”Luchsinger also notes that the ingredient has several FDA-reviewed and patent-protected claims, including that it reduces weight gain, reduces body fat, increases lean muscle mass, and maintains body weight.

In addition, Clarinol benefits from an extensive public relations campaign launched by Lipid Nutrition in 2003 that has resulted in more than 135 million press impressions.

“The Clarinol campaign has encompassed television, radio, the Internet, consumer magazines, and even the Clarinol Caravan six-city fitness and nutrition tour,” Luchsinger says. “We believe it has been successful, as we have seen a jump of 35% in brand awareness, and our Web site has had a 50% increase in consumer questions related to CLA and Clarinol.”

CHROMIUM PICOLINATE

Another ingredient that may be useful for weight loss and building lean body mass is chromium picolinate, an essential trace mineral that plays an important role in the metabolism of carbohydrates, fats, and proteins.

“Chromium picolinate can help reduce body fat and maintain lean muscle,” says Komorowski. “It also does not have side effects like those associated with stimulants.”

Aside from its role in metabolic processes, chromium picolinate is important for the proper functioning of insulin, Komorowski explains.

“Chromium picolinate has the marked advantage of providing body composition benefits by enhancing glucose utilization and insulin sensitivity,” says Komorowski. “This combination provides for gradual weight reduction that can improve a number of health markers concomitantly.”

According to Nutrition 21, chromium picolinate has been shown in 11 clinical trials to be more bioactive in insulin-resistant people than other forms of chromium. Moreover, the company notes that in a sample of 31 studies using chromium picolinate, chromium polynicotinate, and chromium chloride, chromium picolinate had the most studies supporting its efficacy.

Furthermore, Nutrition 21 announced in February that Children’s Hospital (Los Angeles) is planning a double-blind, randomized, placebo-controlled trial that will examine the effects of Chromax chromium picolinate on overweight children with type 1 diabetes. In the study, 30 patients will receive either 600 µg of chromium picolinate or a placebo. After seven months, the researchers will assess HbA1c levels, which measure long-term glycemic control, and body weight and body mass indexes.

COLEUS FORSKOHLII

OMEGA-3S MAY HELP CURB OBESITY

Omega-3 fatty acids are already known for their ability to protect the cardiovascular system. However, new research has also shed light on their potential as weight-control agents. According to a study published in the December 2004 issue of the journal Lipids, the omega-3 fatty acid docosahexaenoic acid (DHA) activates genes that break down fat in the mitochondria and peroxisomes. In the study, which involved experimental animals, DHA increased fat oxidation and reduced the number of fat cells.

“It is well established that a diet rich in seafood prevents weight gain, but the mechanisms responsible for this effect have not been known,” says Morton Bryhn, MD, PhD, director of research and development at Pronova Biocare (Lysaker, Norway), which manufactures EPAX omega-3 fatty acids. “The article presents effects on weight reduction in obesity-prone animals using different omega-3 concentrates containing eicosapentaenoic acid or DHA. These animals behave very much like humans in the way that overfeeding leads to severe obesity.”

Bryhn adds that in a pilot study presented at the North American Association for the Study of Obesity’s (Silver Spring, MD) annual meeting last November, obese women who were put on a low-calorie diet and given omega-3 supplements lowered their weight 20% more than obese women on a low-calorie diet who received placebos. After three weeks of treatment, body mass index (BMI) dropped by 15%. A larger study is planned to test the effects of Pronova’s EPAX 1050 TG against a placebo.

The herb Coleus forskohlii, a member of the mint family that grows in subtropical and warm climates, also has shown promise at improving body composition, according to Indian scientists.

In July 2004, researchers who conducted a 12-week double-blind, randomized study funded by Sabinsa found that volunteers who took 250 mg of ForsLean lost an average of 4% of their total body weight. Moreover, in an independent review in 2004, Cantox Health Sciences International (Mississauga, ON, Canada) confirmed the safety of ForsLean at levels of up to 500 mg per day.

“ForsLean has been studied and independently tested in several clinical trials,” says Sabinsa’s Norton. “Results show an overall trend to decrease body weight and fat content while maintaining or increasing lean body mass. Lean body mass helps regulate the body’s metabolism and actually regulates body fat to maintain it at healthy levels.”

OTHER INGREDIENTS

Although some ingredients aim to promote weight loss by building lean muscle mass, others take a variety of nonstimulant approaches. Two of these ingredients, 7-Keto and NeOpuntia, have been incorporated into successful weight-loss products.

Humanetics Corp.’s (Eden Prairie, MN) 7-Keto enhances the activity of enzymes that break down fat and convert it to energy, according to Scott Steil, the company’s vice president of sales and marketing. He adds that 7-Keto also increases the body’s ability to produce heat from stored fat and has been shown in a recent clinical trial to boost metabolism by 5.4%.

“When a person starts a diet, they lose weight during the early phase,” Steil explains. “However, over time it becomes harder to lose weight while restricting calories because the body slows the rate at which calories are burned. 7-Keto helps to eliminate this drop in metabolism and enhances the weight loss experienced by consumers.”

Steil notes that in the company’s most recent study, 7-Keto was shown to increase the metabolism of individuals placed on a severely restricted-calorie diet by 5.4% compared with individuals who were on the same diet but received a placebo. One additional benefit of 7-Keto, according to Steil, is that Humanetics has already established a large research portfolio.

“In our opinion, the efficacy and safety of 7-Keto is backed by a world-class clinical trial pedigree,” Steil says, noting that 33 articles, including 10 human safety and efficacy trials, have been published on the ingredient. “Prior to any sales of 7-Keto as a dietary supplement, we performed rigorous preclinical toxicology studies and also conducted an extensive human safety clinical trial. These data were presented to FDA when we filed our premarket notification.”

NeOpuntia, which is marketed by BioSerae Laboratories (Bram, France), is composed of two dietary fibers derived from GMO-free cactus that work together to reduce fat absorption through hydrophobic interactions, according to Jeremy Jean-Louis, the company’s marketing manager.

Although there are other fat-blocking ingredients on the market, NeOpuntia, which won the silver award for most innovative health ingredient at last year’s HI Europe conference in Amsterdam, has some novel properties.

“NeOpuntia is produced using a gentle and solvent-free process, unlike the production of chitosan, which uses a strong solvent,” Jean-Louis says. “NeOpuntia is also allergen-free, while chitosan is not recommended to people with a shellfish allergy.”

Furthermore, NeOpuntia’s effectiveness is not pH-based. “If you look at pH during digestion, you see that from the stomach to the intestine, the pH value increases. NeOpuntia binds fat and keeps it bound at any pH while chitosan first binds and then releases it so it is available for digestion,” Jean-Louis says.

Jean-Louis adds that in a comparative study conducted in 2004 by TNO Nutrition and Research (Zeist, The Netherlands), NeOpuntia was found to decrease the bioaccessibility of fatty acids by 28.3%, while chitosan was shown to have no effect.

A GROWING MARKET

Despite the disappearance of ephedra from the marketplace, the weight-loss category is growing, note both Komorowski and Steil. That’s hardly the bleak scenario that some industry insiders predicted at the end of 2003.

“With the incidence of obesity dramatically rising, there is even a greater need for safe and effective weight-loss products,” Komorowski says. “In addition, manufacturers are looking for new ingredients to replace those vacated by the removal of ephedra and ephedra-like ingredients.”

“The pool of potential customers is growing each year, and many of them look for supplements that will help achieve their weight-loss goals,” Steil adds. “Based upon continued enforcement from FDA and the Federal Trade Commission, marketing companies are demanding more science behind the ingredients they use to build their next generation of weight-loss products.”