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The Weight-loss Challenge

Weight Management Weight Management
AIDP

When offering ingredients, suppliers are taking a multi-pronged approach to address the complexities of weight management.

More than 35 percent of adults in the U.S. (estimated 78 million adults) are either overweight or obese, according to the CDC (Centers for Disease Control and Prevention). Further, being overweight or obese increases health risks for metabolic syndrome including heart diseases, hypertension and type 2 diabetes.

Annie Eng, CEO of Florida-based HP Ingredients, noted that according to Statisticbrain.com, survey results released on January 26, 2015 sourced by the University of Scranton and the Journal of Clinical Psychology reported that “losing weight” was the No. 1 resolution held by Americans. “However, a paltry 8 percent say they have been successful in achieving their New Year’s resolution in the past. All this adds up to a juggernaut of a market!”

“The market for weight management supplements continues to grow,” said Bruce Abedon, PhD, director of scientific affairs with Vermont-based Icon Group LLC. “As Americans become more overweight and obese, they are increasingly looking for ways to augment healthy diet and lifestyle changes with dietary supplement products that utilize clinically tested nutraceuticals with demonstrated weight-management benefits.”

“Supplements will always be an important part of the weight-management category because of their convenience, agreed Mitch Skop, senior director new product development, with New Jersey-based Pharmachem Laboratories Inc. “Our challenge as an industry is to put their use in perspective and not overpromise which leads to regulatory problems and negative publicity.”

And, according to Vladimir Badmaev, MD, PhD, and CEO of New York-based American Medical Holdings, “There are many promising nutritionals in the field of fighting overweight and obesity but they need to be systematically and consistently researched to arrive at a safe and effective weight management product. The reason why we are losing battle with obesity may be as simple as the lack of distinction between the cause of obesity, and the risk factors that increase the likelihood of developing overweight or obese conditions,” he said. “The calorie-dense Western-type diet, super-sizing meals, overeating, snacking and sedentary lifestyle qualify as the risk factors. However, a common cause of obesity may ultimately be not in the calories, carbs and fats but in the mechanism that directly and actively promotes obesity. Each of us has a natural protective metabolic mechanism against obesity, which can be overwhelmed when the body is frequently barraged by food. When we arrive to that turn-around point the body can respond with misguided pathological mechanisms, which in time become the cause of obesity and/or type 2 diabetes mellitus.

“To sum up,” Badmaev added, “the current state of the market for weight-loss supplements is ready for a change of direction into seeking and addressing the cause of obesity and the related treatment, rather than fight the risk factors with supplements that may be a Band-Aid fix.”

Thermogenesis, Satiety and More

Xiaoming “Sandy” Chien, PhD, vice president of Innovative Products, with California-based HORN Nutraceuticals, confirmed that thermogenics and satiety suppressants are both important for weight management. “Thermogenesis can be stimulated by certain supplements to increase the energy expenditure and fat oxidation,” she said. “Satiety suppressants are used to reduce hunger and decrease appetite or food intake. While thermogenesis controls the output, satiety suppressants controls the input. So, both thermogenesis and satiety control can work synergistically to help in weight loss.”

Anurag Pande, PhD, vice president of scientific affairs, with New Jersey-based Sabinsa Corporation, agreed that different factors work in unison and help support healthy weight loss. “It is true that both thermogenesis and satiety play important roles. The presence of both factors actually synergizes the weight-loss effect.” However, since no two individuals are the same, nor are their lifestyles, it is worthwhile noting specific consumer interest can often focus on either a product that provides thermogenesis or satiety. Marketers in this area typically have focused in on one of them; in more recent times, lack of innovation has led to formulations involving both aspects, but that may not be optimal for every consumer. There is also interest in products with a more personalized approach when it comes to these two factors.”

Abedon noted that while experts agree that both thermogenesis and satiety are mechanisms for losing weight, “these are not the only mechanisms available for promoting healthy weight management,” he added. “The best ingredients encompass multiple mechanisms: thermogenesis, satiety, as well as others.” That is why Icon Group ingredients have been developed to be multifunctional, incorporating a range of mechanisms to support a comprehensive weight management regimen, including: satiety; appetite control; thermogenesis by non-stimulant means; support of healthy leptin and adiponectin function; control of digestive enzymes that break down carbohydrates and lipids; and enhancement of antioxidant activity.

Weight management via natural ingredients is a broad and promising—albeit sometimes confusing—category because of the variety of different mechanisms that are related to the energy management component of weight control, added Dr. Barbara Davis, vice president, medical and scientific affairs with New Jersey-based PLT Health Solutions.

“A sensible, long-lasting way to manage a healthy weight is to incorporate multiple modifications into a person’s lifestyle,” Davis said. “Of course these modifications involve healthier eating and physical activity. Supplements can also play a critical role—helping with hunger, helping to improve satiety, manage blood sugar and enhancing results. They can help people take charge of their lives and reinforce these modifications with progress.”

PLT Health Solutions participates in the weight management space with ingredients that operate in three approaches to weight control—appetite modification (satiety), control of fat reserves and the increase of thermogenesis. “Whether as standalones or as ingredients in combination with other weight management approaches, these are all safe, effective, science-supported ingredients that can be used to help companies in both the natural products and food and beverage markets develop effective products that consumer can trust,” Davis noted.

Carbohydrates and Weight Loss

The question of satiety or thermogenesis is difficult to answer definitively, Skop said, because each human organism is unique in how it responds to the two stimuli. “We would certainly encourage consumers to take time to ponder and understand the most significant reason they are overweight—lack of exercise, eating too much, or the wrong types of foods. For that reason, we’d like to add another ingredient category: carb blockers.”

Numerous studies have shown that carbohydrates are the culprit contributing to most weight gain, Skop said, adding that consequently, the use of a carb blocker, such as white kidney bean extract, can be an important tool to help consumers bring their weight under control.

In the largest human study conducted, to date, those subjects taking a proprietary extract of the white bean, PhaseLite (Phase 2 Carb Controller) lost significantly more weight than those on placebo after 12 weeks. In addition, 73.5 percent of the participants in the weight management phase successfully maintained their body weight after 24 weeks. In the double-blind weight-loss phase, 123 subjects were randomized to receive either the bean extract or placebo. All subjects adhered to a mildly hypocaloric diet. Body weight and other body composition parameters were measured at baseline and every four weeks thereafter. During the single arm, open label weight management trial, energy intake of the 49 subjects was not controlled. Efficacy parameters were measured at baseline, weeks 12 and 24.

According to lead researcher Dr. Barbara Grube, the researchers also discovered other secondary efficacy parameters. For instance, after 12 weeks, the active group lost significantly more body fat mass and waist circumference compared to the placebo group. The researchers concluded that the reduction in body weight was due to the loss of fat mass, instead of muscles. Improvement in body composition was also shown in the significant reduction in waist measurement in the active group compared to the placebo group.

Weight-loss Advances

In the past, many weight management ingredients were stimulant-based to help increase metabolic rate as a mechanism to address weight issues, noted Icon Group’s Abedon. “These days weight-management ingredients utilize a range of healthy mechanisms of action to help promote weight loss. For example, Icon Group ingredients, such as LeptiCore, WellTrim iG, Synetrim CQ and DygloFit, address weight management by helping to increase satiety and appetite control, promote thermogenesis by non-stimulant means, support healthy function of leptin and adiponectin, control activity of digestive enzymes that break down carbohydrates and lipids, as well as utilize antioxidants to support superior health,” he said.

“Earlier weight-loss products often used to target quick weight reduction, but a more recent concept that has caught lot of interest is about increasing lean body mass,” added Pande. “Lean body mass is healthy mass and makes the body more muscular. In weight-loss programs, the emphasis should be on increasing lean body mass while decreasing the overall weight; this will ensure that the body doesn’t lose vital components such as proteins from the body, which form the muscular structure,” he explained.

To gain lean body mass, it is important to increase fat metabolism in the body, Pande explained. It was observed that this fat metabolism could be enhanced by using the “break-block-burn” effect. This effect is found in the synergistic blend of LeanGard, a blend of natural patented plant extracts of coleus forskohlii (ForsLean), black pepper extract (BioPerine) and garcinia extract (GarCitrin). This combination helps in the management of healthy weight by breaking the fat in fat cells with forskolin, and burning the fat by the HCA in the GarCitrin. Fat formation was also inhibited by HCA’s effect on citrate lyase and excess calories were reduced because of garcinia’s appetite suppressant effect.

According to Chien, another noteworthy advancement in weight-loss ingredients promotes healthy blood sugar management, such as in MealShape, HORN’s patented and scientifically proven ingredient that can instantaneously reduce postprandial glycemia. Another advancement targets toxic visceral fat, which an ingredient like ChalCurb has been clinically proven to reduce. “There is a rightful demand for science-based ingredients, such as MealShape and ChalCurb, which we recognize is not fleeting trend,” Chien added.

The idea of eating food to lose weight is ironic, said Skop. “But there are some ingredients such as Phase 2 that can be incorporated into food and work in-vivo within the food matrix to help encourage satiety, thermogenesis and carbohydrate absorption inhibition.

“What’s very new, from our perspective, is a culinary herb-infused Phase 2 sprinkle powder prototype we call DietSpice,” he added. Open the pack of your taste buds’ desire (Asian, Italian, Herb and Butter and Cinnamon) and simply sprinkle it on or mix it into a carbohydrate-containing meal or serving. “Consumers do not have to learn how to open a package and eat—and many want to spice up what’s on their plates for a more enjoyable dining experience,” Skop noted. “The fact that weight-conscious consumers can now obtain specific benefit through this food product is, or should be, a new hybrid category of active benefit-supplement and functional food.”

Missed Opportunity

The concept of “healthy aging,” a term that typically is applied to ameliorating conditions/occurrences that are specific to an older demographic, is also appropriate for weight loss, according to Davis. “It is probably accurate to say that weight management is the single most important and effective thing that people can do—at any point in their lives—to age more healthfully. An unhealthy weight is the underlying or contributing cause to any number of chronic health conditions present in later years such as CVD (cardiovascular disease) and can exacerbate others like joint health.”

In fact, more than one-third of older adults aged 65 and over was obese in 2007–2010. WHO EU (World Health Organization European Union) data reported that in all countries, higher prevalence of overweight and obesity was demonstrated among older people (50–64 years) than in the younger age group (25–49 years). (Doak 2012 Obesity Rev).

“And yet there are relatively few weight-loss supplement products targeted to the senior demographic,” Davis noted. “If you Google ‘weight loss’ and ‘seniors,’ almost every product you can buy is for a dog! This may be because of a concern about the impact of a weight-loss program on muscle mass and bone mineral density. Most products for seniors focus on ‘fixing’ existing issues, providing supplemental nutrients and weight/muscle gain. At the same time, there is a great deal of solid science that shows that, properly applied, weight management has a number of extremely important benefits for seniors—both metabolic and functional.”

Davis noted that while most weight-management ingredients can be formulated as a supplement, things like protein and fiber are more challenging to deliver this way. And seniors are often thought of as having a “pill burden.” So a weight-management product that featured these important constituents would be best formulated as chews, beverages or in functional foods.

Utilizing Ingredients

PLT Health Solutions markets three different ingredients in the weight management/control space—Xanthigen, Satiereal and Adipromin.

Xanthigen supports healthy body weight through the synergistic effects of the natural compounds found in brown seaweed (Undaria pinnatifida) and pomegranate seed oil. Separately, the bioactive compounds in these two ingredients target pathways involved in body weight regulation including adipocyte differentiation, resting energy expenditure and lipid metabolism. Combined they support weight loss as demonstrated by clinical research.

Satiereal, derived from saffron, induces a satiated feeling and encourages weight loss while eliminating frustration. This product has a unique mechanism that not only creates satiety but helps avoid snacking and compulsive eating behaviors, which in turn may lead to reduction in weight and inches.

Adipromin is a patent-pending, clinically studied dietary ingredient composed of Moringa olifera, Murraya koeingii, and turmeric extracts that targets body composition by inhibiting adipose (fat) cell formation and enhancing the breakdown of fatty tissues. In a double-blind, placebo-controlled human study, Adipromin has been shown to promote weight loss, reduce body mass index (BMI) and positively impact cholesterol, triglycerides and serum adiponectin levels.

HP Ingredients’ Eng said unique but powerful blends of raw materials make for compellingly effective weight-control ingredients (among other condition-specific applications). For example, the company’s CitruSlim is an innovative nutraceutical ingredient for healthy weight management. It is a proprietary blend of citrus flavanone-O-glycosides from bergamot and eurypeptides from Eurycoma longifolia that can promote an anabolic state, reduce cortisol, activate AMPK (AMP-activated protein kinase, an enzyme), reduce triglycerides, and help balance blood glucose levels. CitruSlim can promote healthy weight loss by helping dieters maintain high energy levels during weight-loss programs, prevent the body from storing fat and reduce appetite.

“Consumers vary in the types of delivery systems they prefer for weight-management products, and so nutraceutical ingredients that can be utilized in multiple delivery systems have an advantage in today’s market,” said Abedon. Icon Group ingredients may be used in dry applications such as capsules, tablets and dry mix formulations. Because these ingredients are water-soluble, they may also be incorporated into gummies and liquid supplements such as shots and RTD (ready-to-drink) beverages, Abedon added. The majority of Icon ingredients are GRAS (generally recognized as safe)-affirmed, as well, allowing them to be used in foods such as bars and also in beverages sporting a nutrition facts panel.

The garcinia extract, CitrinK, sold by Sabinsa is another example, which has caught lot of interest, also with food formulators. CitrinK is included in several food products on the market such as in coffee, tea, and water. Since the taste profile is adequate for adding in such beverages without impacting taste, CitrinK has become part of several liquid supplements and beverages. While interest in beverages continues, the mainstay for this category continues to be capsules and tablets.

Chien noted that liquids and beverages can still be a challenge for many marketers depending on the stability and solubility of each ingredient. HORN BlastMax is a new delivery form that stores active ingredients in a universal bottle cap. “When in need, you just place the HORN BlastMax cap on a water bottle, blast the ingredients into the water with a push of a button and you will enjoy your drink instantly,” Chien explained. “The HORN BlastMax technology can increase the shelf life of the actives. It can also reduce the use for fillers and excipients.”

Studies on Weight

Consumers are very concerned about the safety of weight-loss ingredients, therefore suppliers are putting more effort in conducting safety as well as efficacy studies in establishing the science behind all the products. “Both MealShape and CharCurb have double-blind, placebo-controlled studies to back up the science,” said Pande, “and we are continuing to do more studies to support these innovative weight loss products.”

While providing healthy weight management benefits and also contributing to metabolic wellness in such areas as blood sugar balance, cardiovascular health, and healthy blood pressure, Icon Group’s Abedon noted that, “The industry’s top finished goods marketers are looking for multifunctional ingredients to formulate with that provide benefits of this type, which have been evaluated in human clinical trial research. Because of these requirements, and also to substantiate structure/function claims in the areas of weight management and metabolic wellness, each Icon Group ingredient has been studied in one or more randomized, double-blind, placebo-controlled, human clinical trials and have been shown to be significantly better than a placebo group for a large number of weight and metabolic-related health benefits. This type of research is considered the ‘gold standard’ by the scientific community for demonstrating an ingredient’s efficacy as well as safety.”

“As ingredient suppliers,” Pande added, “we’re constantly asked for clinicals using our branded ingredients, tested for a variety of parameters. Interestingly, the more reputable marketing companies are not just looking for significant weight loss, they want to make sure the patients are healthy even after the clinical has ended.”

The double-blind, placebo-controlled study is the “gold standard” of scientific work in the industry. “Beyond this, studies need to have enough subjects to be sufficiently ‘powered,’” said Davis. “They need primary endpoints that are relevant. They shouldn’t be designed around diseases and conducted with unhealthy subjects—because these results invite drug-type claims. The real answer is: you’re never ‘done’ studying the ingredients you market. It’s a form of support for your customers who are looking to build their own consumer brands, and these brands need continued nurturing. We can always learn more about the impact of our ingredients in supporting good health. Things like mechanism of action, dose response (can we do the same thing with less?) and corollary benefits are examples of why we might continue to study our ingredients once they have achieved the “claim threshold.”

Ensuring efficacy and safety of these products requires human clinicals, hands down, said Skop. “This info is frequently filtered to the retailers and their consumers, and many consumers do not understand how to interpret the relevance of rat studies for their own benefit. While we ‘industry-ites’ appreciate what animal studies can teach us, if that’s all there is, consumers won’t bite.”

Pande concluded, that in terms of safety, the age-old rule applies: test, test and test again. “For efficacy, clinicals are nice, but ensure they are repeatable, with scope to learn about possible side effects.” NIE

For More Information:
American Medical Holdings, www.adaptrin.com
HORN Nutraceuticals, (800) 442-4676
HP Ingredients, (877) 437-2234
NutraGenesis/TradeWorks Group/Icon Group, (802) 257-5345
Pharmachem Laboratories, (800) 526-0609
PLT Health Solutions, Inc., (973) 984-0900
Sabinsa, (732) 777-1111

Extra! Extra! – Dr. Badmaev

Extra! Extra! – Chase Hagerman