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GRAS Status


ChromeMate®’s GRAS Status

Nutraceuticals patented form of biologically active, niacin-bound chromium, has successfully been affirmed GRAS (Generally Recognized as Safe) for use in functional beverages by the Burdock Group, the nations leading toxicology specialists in evaluating the safety of food and beverage ingredients. The process involved an intensive review of all safety and toxicology data by a panel of scientific experts.

Generically known as chromium nicotinate or chromium polynicotinate, ChromeMate® is a unique, patented form of oxygen-coordinated, niacin-bound chromium that plays a vital role in proper insulin function, maintenance of healthy blood sugar and normal cholesterol levels, energy production, and promotion of healthy body weight. Protected by three U.S. Patents, four international patents and other worldwide patents pending, ChromeMate® is the only form of niacin-bound chromium with proven biological activity.

Studies have shown that ChromeMate® is 18-times more bioactive than other forms of niacin-bound chromium and, in animal studies used to evaluate bio-availability in humans, is absorbed and retained 600 percent greater than chromium chloride and 300 percent greater than chromium picolinate*. Additional clinical (human) and sub-clinical (animal) studies have shown that ChromeMate® promotes normal cholesterol levels, reduces body weight, increases lean body mass and promotes proper insulin function in the body. One study showed that ChromeMate® plus exercise in obese women resulted in significant weight loss, while chromium picolinate did not. Another study in obese human subjects showed that ChromeMate® reduced body fat, while sparing lean muscle mass. All these human clinical studies demonstrated no adverse effects of ChromeMate®.

A wide range of studies, which provide the foundation for GRAS affirmation, have also been conducted to validate the safety of ChromeMate®. A 90-day sub-chronic toxicity study that evaluated body weight, feed and water intake, hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, selected organ weights as such and as a percentage of body weight and brain weight, and 32 organ histopathology, showed no adverse effects after administering three doses of ChromeMate®: (i) a human equivalency dose (HED), (ii) 10x HED and (iii) 25x HED of the supplement. Acute oral toxicity testing revealed no oral toxicity at levels up to 5,000 mg/kg of body weight and the median lethal dose (LD 50) was greater than 5,000 mg/kg. No dermal toxicity was observed. No significant skin and eye irritation potential of ChromeMate® was observed. Amesbacterial reverse mutation assay and mouse lymphoma tests demonstrated that ChromeMate® is non-mutagenic and does not have genotoxic potential. Far in excess of the recommended daily dosage of 200-400 micrograms, these tests indicate that it is highly unlikely a single, dose would cause harm.

Two elements were key in the decision to certify ChromeMate® for GRAS status,stated Dr. George Burdock, president of the Burdock Group. First was the historical foundation; trivalent chromium is essential for carbohydrate and lipid metabolism in animals and humans, and has a history of safe use. Further support came from extensive toxicology studies on salts of trivalent chromium, including ChromeMate®, that provided safety confirmation according to modern scientific standards. This information, along with other data reviewed, provided the substantiation needed to confidently make the GRAS determination.

The scientific panels decision to confer GRAS status on ChromeMate® is an important one for the industry and for consumers,stated InterHealth president & CEO William SkipSeroy. Consumers continue to embrace functional foods and beverages as major components of a healthy lifestyle. Given the plethora of ineffective and sometimes dangerous products on the market today, the proven safety and efficacy of ChromeMate®, as exemplified by its clinical research and GRAS status, is especially important for consumers who seek safe and efficacious assistance in their quest for optimal health.

The panel of experts who made the GRAS determination included Joseph Borzelleca, Ph.D. (Professor Emeritus, Medical College of Virginia), who has more than 40 years experience in determining the safety of food and beverage ingredients; Robert Cousins, Ph.D. (Boston Family Professor of Human Nutrition and Biochemistry, University of Florida); and George Burdock, Ph.D. (president, Burdock Group). Dr. Burdock is also president of the Food Safety Specialty Section of the Society of Toxicology, the largest toxicological society in the world.

A product of InterHealth Nutraceuticals Inc., ChromeMate® is a value-added dietary ingredient available to manufacturers for inclusion in a full array of dietary supplements and nutraceutical food and beverage products. InterHealth researches, develops, manufactures, markets and distributes specialty nutritional ingredients, which are sold to manufacturers worldwide.

*Results of six tissues tested one hour after administration. Absorption and retention decreased in all groups at each successive time point measured, but continued to be greatest in animals fed ChromeMate®.

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Anti Aging


Trace Elements May Reduce Aging Associated with Insulin Resistance

Adequate consumption of certain trace elements may counter the aging process by interfering with the development of insulin resistance, which commonly occurs with aging. Chromium and selenium compounds have been shown to influence plasma insulin levels and/or insulin effectiveness. Low dietary intake and blood levels of zinc are associated with cardiovascular disease and diabetes. Vanadium compounds have been shown to have insulin-like effects, along with anti-diabetes and anti-heart disease properties. Consumption of these elements in supplement form may reduce insulin resistance and thereby improve long-term health.

Source: Bagchi D, Beneficial Roles of Chromium, Selenium, Zinc and Vanadium on Insulin Resistant Syndrome, Journal of the American College of Nutrition, 20 (5):581, Abs. 79, 2001.

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Reduce Aging


ChromeMate® and OptiZinc® Found to Reduce Signs of Aging

Researchers at Georgetown University Medical Center and Creighton University School of Pharmacy have shown that a combination of ChromeMate®, OptiZinc® and grape seed extract can influence metabolic changes associated with aging. Experimental animals that received the supplements for a one-year period had lower blood pressure, less free radical formation, and lower levels of glucose-linked proteins (associated with poor glucose regulation) than control animals. No signs of toxicity were associated with long-term consumption of these supplements.

Source: Preuss HG, Montamarry S, Echard B, Scheckenbach R, Bagchi D, Long-Term Effects of Chromium, Grape Seed Extract and Zinc on Various Metabolic Parameters of Rats, Molecular and Cellular Biochemistry, 223:95-102, 2001.

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ChromeMate® Found to be More Bioavailable than Other Chromium Supplements Tested

Researchers at the University of California, Davis, have shown that, in animal models used to evaluate bioavailability in humans, chromium nicotinate (ChromeMate®) is absorbed and retained significantly better than either chromium chloride or chromium picolinate. One hour after administration, animals fed ChromeMate® absorbed and retained an average 311% more chromium than chromium picolinate and 672% more than chromium chloride in six tissues tested, including liver, pancreas, kidney, blood, testes and muscle. Absorption and retention decreased in all groups at each successive time point measured (3, 6 and 12 hours), but continued to be greatest in animals fed ChromeMate®.

Source: Olin KL, Stearns DM, Armstrong WH, Keen CL, Comparative Retention/Absorption of 51Chromium (51Cr) from 51Cr Chloride, 51Cr Nicotinate and 51Cr Picolinate in a Rat Model, Trace Elements and Electrolytes, 11:182-186, 1994.

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Reduce Cholesterol


ChromeMate® Shown to Reduce Cholesterol Levels in Humans

Researchers at Georgetown University School of Medicine and Creighton University found that ChromeMate® significantly reduced total and LDL cholesterol in people with high blood cholesterol levels. Subjects consumed either placebo or 200 mcg chromium polynicotinate (ChromeMate®) twice a day for two months. Compared to placebo, subjects consuming ChromeMate® had a 10% reduction in total cholesterol and a 14% reduction in LDL cholesterol levels.

Source: Preuss HG, Wallerstedt D, Talpur N, Tutuncuoglu SO, Echard B, Myers A, Bui M, Bagchi D, Effects of Niacin-Bound Chromium and Grape Seed Proanthocyanidin Extract on the Lipid Profile of Hypercholesterolemic Subjects: A Pilot Study, Journal of Medicine, 31:227-246, 2000.

Researchers at Georgia Southern and Auburn Universities showed that supplementation with 200 mcg of chromium as chromium-nicotinic acid complex (ChromeMate®) significantly lowered moderate levels of cholesterol by an average of 14% and improved total cholesterol:HDL (“good cholesterol”) ratios by 7% in male athletes.Source: Lefavi RG, Wilson D, Keith RE, Anderson RA, Blessing DL, Lipid-Lowering Effect of a Dietary Chromium (III)-Nicotinic Acid Complex in Male Athletes, Nutrition Research, 13:239-249, 1993.

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Fat Loss


ChromeMate® Found to Increase Fat Loss and Spare Lean Body Mass in Obese Women

In a placebo-controlled, cross-over study, researchers at Georgetown University Medical Center showed that overweight African-American women consuming 600 mcg chromium as niacin-bound chromium (ChromeMate®) for 8 weeks had a significant loss of body fat and sparing of muscle (lean body mass) compared with a prior placebo period of the same duration. Increased fat loss was also observed among women who were randomized to consume chromium first, followed by placebo, suggesting a carry-over effect of the supplementation on fat loss. No adverse effects were observed.

Source: Crawford V, Scheckenbach R, Preuss HG, Effects of Niacin-Bound Chromium Supplementation on Body Composition in Overweight African-American Women, Diabetes, Obesity, and Metabolism, 1:331-337, 1999.

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Reduce Weight


ChromeMate® Plus Exercise Found to Reduce Weight in Obese Women

Researchers at the University of Texas, Austin, found that young obese women consuming 400 mcg of chromium as chromium nicotinate (ChromeMate®) per day in combination with exercise experienced significant weight loss over an eight week study period, while exercise plus chromium picolinate did not. Insulin response to an oral glucose load was also lowered in subjects who consumed ChromeMate® and exercised.

Source: Grant KE, Chandler RM, Castle AL, Ivy JL, Chromium and Exercise Training: Effect on Obese Women, Medicine & Science in Sports & Exercise, 29:992-998, 1997.

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Reduce Body Weight


ChromeMate® and Maitake Mushroom Found to Significantly Reduce Body Weight, Blood Pressure and Fasting Blood Glucose Level in Rats

Maitake mushroom has been reported to favorably influence hypertension and diabetes mellitus. Researcher

s at Georgetown University Medical Center demonstrated that diabetic rats receiving a combination of Maitake mushroom water-s

oluble fraction and ChromeMate® reduced body weight, blood pressure and fasting blood glucose levels significantly more than diabetic rats receiving either Maitake mushroom water-soluble fraction alone or no special treatment (control group). Thus,

ChromeMate® with Maitake mushroom water-soluble fraction may serve as a novel tool in

promoting healthy blood pressure and blood sugar levels.

Source: Talpur NA, Echard BW, Fan AY, Jaffari O, Bagchi D, Preuss HG, Antihypertensive and Metabolic Effects of Whole Maitake Mushroom Powder and its Fractions in Two Rat Strai

ns, Molecular and Cellular Biochemistry, 237:129-136, 2002.

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Improves Performance


ChromeMate® Improves Performance in Elite Cyclists

In a double-blind cross-over study, researchers at the University of Dayton (Dayton, OH) investigated the effect of a carbohydrate-electrolyte (CE) beverage with or without added ChromeMate® on sprint capacity and power output in elite cyclists. Effects were measured immediately following 60 minutes of cycling at sub-maximal output (75% VO2Max). Total power output was significantly higher for the group consuming the novel carbohydrate-electrolyte beverage with ChromeMate® than for those consuming the carbohydrate-electrolyte beverage alone. Subjects consuming the carbohydrate-electrolyte beverage plus ChromeMate® also demonstrated higher mean VO2 and VCO2 values, and lower respiratory exchange ratio (RER), blood glucose and lactate levels. Thus, it was concluded that a novel CE beverage with added ChromeMate® improved exercise performance in elite cyclists as measured by power output.

Source:Frank LL, Baer JT, The Effect of a Chromium-Containing Beverage on Sprint Cycling Performance After a Submaximal Exercise Bout, American College of Sports Medicine, 49th Annual Meeting in Conjunction with the Sixth IOC World Congress on Sport Sciences, Abstract 14, Page S3, May 28-June 1, 2002, Americas Center, St. Louis, Missouri.

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Syndrome X


ChromeMate® Shown to Ameliorate Symptoms of Syndrome X

Metabolic Syndrome (Syndrome X) is a cluster of risk factors, including obesity, greater abdominal fat, insulin resistance, hypertension and blood lipid abnormalities. Metabolic Syndrome has been linked to the development of type 2 diabetes, cardiovascular disease and aging. Maintaining optimal insulin and blood sugar metabolism has been reported to slow the aging process in laboratory animals. This study examined the effects of three supplements in animals that develop features of Metabolic Syndrome and diabetes with age. Three groups of older rats were supplemented with ChromeMate®, Super CitriMax®, or a maitake mushroom fraction for 6 weeks, while a fourth group served as controls. During the final 3 weeks, a group was given a combination of all three supplements and compared to untreated animals. All three supplemented groups showed significantly lower systolic blood pressure, as well as less free radical damage in liver and kidney tissues over the initial 6 weeks.

During that period, body weight significantly declined in control animals a decline that is characteristic of these animals during the later stages of failing health. In contrast, both the ChromeMate® and maitake supplements largely prevented this anticipated loss. The Super CitriMax® group also lost weight, though fewer experienced a greater than average drop compared to controls. Most importantly, treatment with the combined supplements resulted in a lower systolic blood pressure and better body weight maintenance overall. Results from other experimental studies in younger insulin-resistant animals as well as clinical trials show that ChromeMate®, Super CitriMax® or maitake can favorably alter many risk factors associated with Metabolic Syndrome. The findings from this study suggest that dietary supplements of ChromeMate®, Super CitriMax® and maitake may also benefit people with diabetes, as well as the elderly.

Source: Talpur N, Echard BW, Yasmin T, Bagchi D, and Preuss H, Effects of Niacin-Bound Chromium, Maitake Mushroom Fraction SX and (-)Hydroxycitric Acid on the Metabolic Syndrome in Aged Diabetic Zucker Fatty Rats, Molecular and Cellular Biochemistry, 252:369-377, 2003.

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