Recently, ASER awarded the Seal that recognizes the manufacturers research, the publication of its data, and manufacturing GMP for "SLIMVANCE", a weight loss supplement marketed by General Nutrition Corporation (GNC). The weight loss supplement consists of Moringa leaf, curry and curcumin, all of which are known as superfoods. GNC has provided documentation to ASER that the supplement is manufactured using Good Manufacturing Practices (GMP), which is regulated by the FDA. ASER also verified that Slimvanceis not contaminated with adulterants and contains only the ingredients listed.
The published data shows that the conventional baseline weight loss curve plateaus at about 6 months with an obesity medication. Approximately 50% of weight loss occurs in the first 8 weeks, approximately 67% of weight loss occurs at 12 weeks, and approximately 80% of weight loss occurs at 16 weeks. SLIMVANCE conducted two randomized double-blind placebo controlled clinical trials that were published in peer-reviewed scientific journals, along with a toxicology study and mechanistic study. The summaries and results of the studies are below.
Efficacy study #1:
In the 1st efficacy study with Slimvance, fifty obese subjects were randomized 1:1 to Slimvance (composed of three foods, Moringa olefera leaf, Murrya koenigii leaves and Curcuma longa roots standardized to total curcuminoids in a ratio of 6:3:1) or placebo. Subjects took a 500mg capsule (300mg supplement and 200mg excipient) three times a day for 8-weeks and attempted to follow a 2000 kcal/d diet with moderate exercise. Subjects lost 4.76 kg compared to 1.79 kg in the placebo group for a weight loss of 2.97 kg more than placebo at 8 weeks (p<0.001) which projects to a weight loss of 5.94 kg more than placebo at the 6-month plateau. The baseline weight was about 85.5 kg making this a 6.94% placebo-subtracted weight loss. There was also a significant trend toward a reduction in fasting blood sugar, LDL cholesterol and triglycerides (p<0.1). Adverse events were minor and included gastric irritation, abdominal pain and back pain. Adverse events were evenly distributed between the treatment and placebo groups
Sengupta K, Misra A, Rao MK, Sarma KVS, Krishnaraju AV, Golakoti T. Efficacy and tolerability of a novel herbal formulation for weight management in obese subjects: a randomized, double-blind, placebo controlled clinical study. Lipids Health Dis. 2012;11:176
Efficacy study #2:
In the 2nd study with Slimvance, one hundred and forty overweight subjects were randomized 1:1 to Slimvance (composed of three foods, Moringa olefera leaf, Murrya koenigii leaves and Curcuma longa roots in a ratio of 6:3:1 standardized to 7% total curcuminoids, 0.1% Mahanine and 0.2% Quercetin 3-O-glycoside) or a placebo. Subjects took a 450mg capsule containing supplement or placebo 2 times a day for 16-weeks and were instructed in a 1800 kcal/d diet with moderate walking exercise 30 minutes five times a week. Subjects lost 5.36 kg compared to 0.87 kg in the placebo group for a weight loss of 4.49 kg more than placebo at 16 weeks (p<0.0001) which projects to a weight loss of 5.39 kg more than placebo at the 6-month plateau. The baseline weight was about 75.5 kg making this a 7.13% placebo-subtracted weight loss. There was a decrease in LDL cholesterol, triglycerides, hip circumference, waist circumference and an increase in HDL cholesterol (all p<0.0001). Adverse events were minor and included fever, gastric irritation, headache, itching, loose stools, increased appetite and dehydration. Adverse events were evenly distributed between the treatment and placebo groups and were thought not to be related to the supplement.
Dixit K, Kamath DV, Alluri KV, Davis BA. Efficacy of a novel herbal formulation for weight loss demonstrated in a 16-week randomized, double-blind, placebo-controlled clinical trial with healthy overweight adults. Diab Obes Metab. 2018;20(11):2633-41
The mechanism of action of the combination of Moringa, Murraya and Curcuma was assessed in mouse adipocytes. The combination of these three foods synergistically inhibited the differentiation of adipocytes in a dose dependent manner and reduced triglyceride in the adipocytes by stimulating lipolysis. The transcription factors, peroxisome proliferator activated receptor gamma (PPAR gamma) and CCAAT/enhancer binding protein (CE/EBP), involved with fat cell differentiation were suppressed. Stimulators of lipolysis like adipocyte specific binding protein 2 (aP2) and perilipin were increased (p<0.02). Together, these responses show that the supplement inhibited lipogenesis and stimulated lipolysis as mechanisms of its action on fat cells.
Sengupta K, Golakoti T, Chirravuri VR, Marasetti AK. An herbal fomula LI85008F inhibits lipogenesis in 2T3-L1 adipocytes. Food and nutr Sci. 2011;2:809-17
A safety and toxicology study was performed on the combination of the foods, Moringa, Murraya and Curcuma. The acute oral LD50 of the combination was greater than 5g/kg in Sprague Dawley rats and there were no abnormalities on autopsy. The acute dermal LD50 was greater than 2g/kg. The combination was not irritating to the skin and caused minimal irritation to the eyes when given acutely to New Zealand white rabbits. A 28d sub-acute toxicity study showed no change in organ weights, hematology or chemistry. The histopathology was normal and the No Adverse Effect Level (NOAEL) was found to be greater than 2.5g/kg. Thus, the three component supplement has a broad safety margin in animal models.
Krishnaraju AV, Sundararaju D, Srinivas P, Rao CV, Sengupta K, Trimurulu G. ToxicologyMechanisms and Methods. 2010;20(2):59-68
Slimvance and Its Advantages in an Obesity Medicine Practice
June 22, 2019
The definition of supplements in the Dietary Supplement Health and Education of 1994 was components of food in the human diet prior to 1994. Dietary supplements can only make structure/function claims such as “this supplement is intended to help maintain a healthy weight”. The laxity of these regulations has given rise to supplements that are not made using Good Manufacturing Practices (GMP), may not have proper standardization to insure that they are the same from batch to batch and may even have adulterants in them. This has resulted in a negative perception of supplements by the medical profession (1).... Although there some dietary supplements that are safe and effective for the treatment of obesity, they are the minority and most physicians have no way to determine which supplements fall into that category. Without the ability to differentiate the safe and effective supplements from the rest, they tend to categorize all supplements as having no value.
The Academy of Science, Education and Research (ASER), a non-profit foundation, is addressing this problem. ASER has a seal of approval for both safety and effectiveness. Supplements that receive this seal are made by GMP, are properly standardized for consistency across batches, have no adulterants and contain only the listed ingredients. The supplements receiving the seal of approval must meet stringent standards of efficacy. The supplement receiving the seal must have at least two double blind, placebo controlled studies published in the peer-reviewed scientific literature confirming that they will give at least a 5% greater weight loss than placebo when projected to the 6-month weight loss plateau. The weight loss curve is not linear. Approximately 50% of the weight is lost in the first 8 weeks, 67% by 12 weeks, and 80% by 16 weeks.
Slimvance is sold by the General Nutrition Corporation (GNC) and is the first supplement to receive the ASER seal. In addition to meeting all the safety criteria Slimvance has four peer-reviewed studies in the scientific literature. One was an 8-week study that showed a 6.94% weight loss in excess of the placebo when projected to the 6-month plateau (2). The second was a 16-week study that showed a 7.13% greater weight loss than the placebo when projected to the 6-month plateau (3). A third study showed that Slimvance reduces body weight by inhibiting the differentiation of pre-adipocytes into fat cells and by increasing lipolysis, the process by which fat cells release their fat (4). The fourth study was a toxicology study that demonstrated that the three herbal components, moringa, curry and curcumin were very safe. One had to exceed doses of 2.5 grams per kilogram per day in rabbits to have any adverse effects and the human dose is less than one gram per day (5).
ASER has created a website for the sale of Slimvance https://asernv.org/news/newsdetail/3 . By using the ASER website to purchase Slimvance, the Obesity Medicine Association (OMA) and The Obesity Treatment Foundation (OTF) will be credited for the sale and GNC has agreed to give $4 per bottle to ASER which will donate to OTF in proportion to the sales of Slimvance through the website. In addition, if the sales of Slimvance through the ASER website reach a certain level, GNC has agreed to private label the Slimvance for the ASER website which will lower the price to members of the OMA and their patients while increasing donations to the OTF. Thus, there are many reasons to try Slimvance as a treatment for your patients and refer your patients to the ASER website to obtain it.
1. Slimvance is the only product with the ASER seal certifying it as safe and effective
2. Slimvance gives 7% more projected weight loss than its placebo in the two studies published in the peer-reviewed scientific literature. Only phentermine with topiramate exceeds the Slimvance weight loss in its clinical registration trials for FDA approval (6).
3. Slimvance did not cause significant side effects in clinical trials suggesting greater safety than the approved pharmaceuticals, which one would expected with food components.
4. Slimvance costs $59.95 for a month supply on the ASER website, which is less expensive than the FDA approved anti-obesity pharmaceuticals except for phentermine which is only approved for use for up to 12 months.
5. The combination of efficacy, safety and cost along with most patient’s desire to use foods rather than drugs as medicine when possible suggests that Slimvance should be the first choice when turning to a supplement or a pharmaceutical to help your patient lose weight.
6. Using the ASER website to obtain Slimvance for your patients will help return money from ASER to the OTF. The OTF helps to support the activities of the OMA. In addition, if the volume of Slimvance sales grows, a private label Slimvance product will be made which will be sold at a lower price and with increased donations to the OTF. If you or your patients purchase Slimvance, please use the ASER website to do so that ASER will help the OTF to help the OMA.
1. Rios-Hoyo A, Gutierrez-Salmean G. New dietary supplements for obesity: what we currently know. Curr Obes Rep. 2016;5(2):262-70.
2. Sengupta K, Misra A, Rao MK, Sarma KVS, Krishnaraju AV, Golakoti T. Efficacy and tolerability of a novel herbal formulation for weight management in obese subjects: a randomized, double-blind, placebo controlled clinical study. Lipids Health Dis. 2012;11:176.
3. Dixit K, Kamath DV, Alluri KV, Davis BA. Efficacy of a novel herbal formulation for weight loss demonstrated in a 16-week randomized, double-blind, placebo-controlled clinical trial with healthy overweight adults. Diab Obes Metab. 2018;20(11):2633-41
4. Sengupta K, Golakoti T, Chirravuri VR, Marasetti AK. An herbal fomula LI85008F inhibits lipogenesis in 2T3-L1 adipocytes. Food and nutr Sci. 2011;2:809-17
5. Krishnaraju AV, Sundararaju D, Srinivas P, Rao CV, Sengupta K, Trimurulu G. ToxicologyMechanisms and Methods. 2010;20(2):59-68
6. Yanovski SZ and Yanovski JA. Lon-term drug treatment for obesity: a systematic and clinical review. JAMA. 2014;311(1):74-86