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George Burdock

The Safety and Efficacy of an extract of Garcinia Cambogia – A Literature Review *

By Sidney J. Stohs, PhD, Harry G. Preuss, MD, Sunny E. Ohia, PhD, Gilbert R. Kaats, PhD, Carl L. Keen, PhD, Lonnie D. Williams, PhD, and George A. Burdock, PhD

“The dried fruit rind of Garcinia Cambodia is used extensively for culinary purposes in Asian countries, where it has been consumed for centuries without harmful effects. It possesses a distinct sweet and sour taste, which it imparts to foods, and when added to foods has been reported to make them more filling and satisfying. (7,10)”

“The first studies involving the effects an extract of Garcinia Cambodia on lipid metabolism were conducted in the 1970s. (14-16)”

Safety Studies

“Various animal (11-13,17-21) and human (22-27) studies have been conducted on the safety of an extract of Garcinia Cambodia. In summary, no serious or significant untoward effects were reported in any of those studies.”

“All reported effects were comparable to placebo-treated animals and human subjects. Dose-dependent studies in animals by Ohia et al. assessed acute oral toxicity, as well as acute dermal toxicity, primary dermal irritation, and primary eye irritation. (11) No gross toxicological findings were observed, and the authors concluded that the extract of Garcinia Cambodia is safe under the experimental conditions employed. In subchronic (90 day) toxicity studies in rats treated with various doses of an extract of Garcinia Cambodia, Shara et al. did not observe any significant changes in organ histopathology, hepatic or testicular lipid peroxidation, or DNA fragmentation. (12)”

“Furthermore, an extract of Garcinia Cambodia.  produced no changes in hematology or clinical chemistry as compared to control animals. (13)
The safety of the potassium/calcium salt of an extract of Garcinia Cambodia. was assessed in 2-generation reproductive toxicity (19) and developmental toxicity (20) studies in male and female rats. The feeding of up to 10,000 ppm (parts per million) of an extract of Garcinia Cambodia.  in the diet did not affect reproductive performance in either sex based on fertility and mating, sexual maturity, gestation, parturition, litter size, or offspring development.”

“Furthermore, no evidence of maternal toxicity or evidence of fetal soft tissue, skeletal, or external abnormalities were noted. The extract of Garcinia Cambodia was not teratogenic at these experimental conditions.”

“In another study, the effect of an extract of Garcinia Cambodia on insulin resistance, oxidative stress, and inflammation was assessed in male Zucker rats over a period of 7 weeks. (21) Compared to control animals, malondialdehyde, protein carbonyl formation, and protein tyrosine nitration (markers of oxidative stress) were significantly lower in the kidney and liver of rats given an extract ofGarcinia Cambodia. Levels of C-reactive protein and interleukin-6 (markers of inflammation) were lower in plasma as compared to control animals. Furthermore, fasting plasma insulin, glucose, and triglycerides, as well as body weights and food intake, were lower in an extract of Garcinia Cambodia – treated animals as compared to controls. Insulin resistance did not develop in an extract of Garcinia Cambodia – supplemented animals but did develop in the controls. (21)”

“In experimental animal studies at up to 25 times the human equivalency dose of an extract of Garcinia Cambodia, there have been no reports of hepatotoxicity or other adverse effects.”

“An an extract of Garcinia Cambodia dose of 2500 mg/kg, equivalent to 150,000 mg in a 60 kg individual, was without adverse effects, including hepatotoxicity or testicular toxicity, in the test animals. (11-13)”

“An excellent summary of the results of 15 Garcinia Cambodia human clinical studies has been provided by Soni et al.26 and Downs et al. (27). Of these studies, 14 of them were double-blind and placebocontrolled, and one was a single-arm, open trial. Over 750 total subjects were involved in these studies. No significant adverse effects were reported in any of these studies following treatment with an extract of Garcinia Cambodia. No pathologic or clinically significant changes in hematologic assays or blood chemistries, including liver enzymes, were observed. These authors concluded that an extract of Garcinia Cambodia at levels up to 2800 mg/day were safe for human consumption. “

“Furthermore, for several individuals with modestly elevated enzyme levels, upon receiving an extract of Garcinia Cambodia these enzymes returned to within the normal range. In addition, in an in vitro protein glycation (glycosylation) system, Bousova et al. demonstrated that an extract of Garcinia Cambodia decreased the formation of glycation products, again suggesting a protective role for an extract of Garcinia Cambodia. (33) Glycation is a process associated with the pathogenesis
of diabetic complications, as well as aging.”

Efficacy Studies

“The ability of orally-administered an extract of Garcinia Cambodia to promote weight loss and contain body weight gain in experimental animals has been demonstrated in various studies, (11-21) beginning as early as 1971. (14) “

“The common observation throughout these diverse studies is that an extract of Garcinia Cambodia administration results in weight loss and/or retards body weight gain (with no significant adverse effects).”

As stated previously, in-depth reviews of the efficacy of an extract of Garcinia Cambodia in weight loss and weight management involving human clinical trials have been published by Soni et al.26 and Downs et al. (27) “

“Eleven studies assessed the effects of an extract of Garcinia Cambodia on weight loss, with most demonstrating a statistically significant effect.”

“Several mechanisms of action have been shown to be involved with respect to the weight loss/weight management effects of Garcinia Cambodia. The ability of an extract of Garcinia Cambodia to act as a competitive inhibitor of the enzyme ATP-citrate lyase may be the primary mechanism. (26-28)”

“The primary mechanism of an extract of Garcinia Cambodia is believed to involve the inhibition of fat synthesis. (39)”

Several other mechanisms may also be involved. For example, Ohia et al. have shown that an extract of Garcinia Cambodia inhibits serotonin uptake in isolated rat brain cortical slices in a manner similar to selective serotonin reuptake inhibitors (SSRIs), (11) and this action may therefore constitute the mechanism whereby an extract of Garcinia Cambodia suppresses appetite.”

Summary and Conclusions

“An ever increasing number of well-designed and appropriately controlled studies in animals and humans have indicated that an extract of Garcinia Cambodia is both safe and efficacious.”

References

*The actual document was headed: “Safety and Efficacy of Hydroxycitric Acid derived from Garcinia Cambodia – A Literature Review” . Hydroxycitric Acid is an extract and the main active ingredient of Garcinia Cambodia and for simplicity sake we refer to it throughout the document as “an extract of Garcinia Cambodia”.

1 to 6 refers to studies done on a competing product.

7. Jena BS, Jayaprakasha GK, Singh RP, Sakariah KK. Chemistry and biochemistry of (-)-hydroxycitric acid from Garcinia. J Agric Food Chem. 2002;50:10–22.
8. Jayaprakasha GK, Sakariah KK. Determination of organic acids in Garcinia cambogia (Desr.) by high-performance liquid chromatography. J Chromatogr A. 1998;806:337–339.
9. Antony JIX, Josan PD, Shankaranarayana ML. Quantitiative analysis of (–)hydroxy citric acid and (–)hydroxy citric acid lactone in Garcina fruits and Garcinia products. J Food Sci Technol. 1998;35:399–402.
10. Sergio W. A natural food, the Malabar Tamarind, may be effective in the treatment of obesity. Med Hypothesis. 1988;29:39–40.
11. Ohia SE, Opere CA, DeLay AM, Bagchi M, Bagchi D, Stohs SJ. Safety and mechanisms of appetite suppression by a novel hydroxycitric acid extract (HCA-SX). Mol Cell Biochem. 2002;238:89-103.
12. Shara M, Ohia SE, Yasmin T, et al. Dose- and time-dependent effects of a novel (–)-hydroxycitric acid extract on hepatic and testicular lipid peroxidation, DNA over a period of 90 days. Mol Cell Biochem. 2003;254:339–346.
13. Shara M, Ohia SE, Schmidt RE, et al. Physico-chemical properties of a novel (–)-hydroxycitirc acid extract and its effect on body weight, selected organ weights, hepatic lipid peroxidation and DNA fragmentation, hematology and clinical chemistry, and histopathological changes over a period of 90 days. Mol Cell Biochem. 2004;260:171– 186.
14. Lowenstein JM. Effect of (–)-Hydroxycitrate on fatty acid systhesis by rat liver in vivo. J Biol Chem. 1971;246:629–632.
15. Sullivan AC, Triscari J, Hamilton JG, Miller ON, Wheatley JR. Effect of (–)-hydroxycitrate upon the accumulation of lipid in rat: I. Lipogenesis. Lipids 1974;9: 121–128.
16. Sullivan AC, Triscari J, Hamilton JG, Miller ON. Effect of (–)-hydroxycitrate upon the accumulation of lipid in rat: II. Appetite. Lipids. 1974;9:129–134.
17. Leonhardt M, Munch S, Westerterp-Plantenga M, Langhans W. Effects of hydroxycitrate, conjugated linoleic acid, and gur\ar gum on food intake, body weight regain, and metabolism after body weight loss in male rats. Nutr Res. 2004;24:659–669.
18. Leonhardt M, Balkan B, Langhans W. Effect of hydroxycitrate on respiratory quotient, energy expenditure, and glucose tolerance in male rats after a period of restrictive feeding. Nutrition. 2004;20:911–915.
19. Deshmukh NS, Bagchi M, Yasmin T, Bagchi D. Safety of a novel calcium/potassium salt of (–)-hydroxycitric acid (HCA-SX): I. Two–generation reproduction toxicity study. Toxicol Mech Meth. 2008;18:433–442.
20. Deshmukh NS, Bagchi M, Yasmin T, Bagchi D. Safety of a novel calcium/potassium salt of (-)-hydroxycitric acid(HCA-SX): II. Developmental toxicity in rats. Toxicol Mech Meth. 2008;18:443-451.
21. Asghar M, Monjok E, Kouamou G, Ohia SE, Bagchi D, Lokhandwala MF. Super CitriMax (HCA-SX) attenuates increases in oxidative stress, inflammation, insulin resistance, and body weight in developing obese Zucker rats. Mol Cell Biochem. 2007;304:93-99.
22. Preuss HG, Bagchi D, Bagchi M, Rao SCV, Satyanarayana S, Dey DK. Effect of a novel, natural extract of (–)-hydroxycitric acid (HCASX) and a combination of HCA-SX, niacin-bound chromium and Gymnema sylvestre extract in weight management in human volunteers. Nutr Res. 2004;24:45–58.
23. Preuss HG, Rao SCV, Garis RI, et al. An overview of the safety and efficacy of a novel, natural (–)-hydroxycitric acid extract (HCA-SX) for weight management. J Med. 2004;33:33–48.
24. Preuss HG, Bagchi D, Bagchi M, Rao SCV, Dey DK, Satyanarayana S. Effects of a natural extract of (–)-hydroxycitric acid (HCA-SX) and a combination of HCA-SX plus niacin-bound chromium and Gymnema sylvestre extract on weight loss. Diab Obes Metab. 2004;6:171–180.
25. Preuss HG, Garis RI, Bramble JD, et al. Efficacy of a novel calcium/ potassium salt of (–)-hydroxycitric acid in weight control. Int J Clin Pharmacol Res. 2005;25:133–144.
26. Soni MG, Burdock GA, Preuss HG, Stohs SJ, Ohia SE, Bagchi D. Safety assessment of (–)-hydroxycitric acid and Super CitriMax, a novel calcium/potassium salt. Food Chem Toxicol. 2004;42:15131529.
27. Downs BW, Bagchi M, Subbaraju GV, Shara MA, Preuss HG, Bagchi D. Bioefficiency of a novel calcium-potassium salt of (–)-hydroxycitric acid. Mutat Res. 2005;579:149–162.
28. Saito M, Ueno M, Ogino S, Kubo K, Nagata J, Takeuchi M. High dose Garcinia cambogia is effective in suppressing fat accumulation in developing male Zucker obese rats, but highly toxic to testis. Food Chem Toxicol. 2005;43:411–419.
29. Hayamizu K, Tomi M, Kaneko I, Shen M, Soni MG, Yoshino G. Effects of Garcinia cambogia extract on serum sex hormones in overweight subjects. Fitoteripia. 2008;79:255–261.
30. Mahendran P, Devi CS. Effect of Garcinia cambogia extract on lipids and lipoprotein composition in dexamethasone administered rats. Ind J Physiol Pharmacol. 2001;45:345–350.
31. Mahendran P, Sabitha KE, Devi CS. Prevention of HCl-ethanol induced gastric mucosal injury in rats by Garcinia cambogia extract and its possible mechanism of action. Ind J Exptl Biol. 2002;40:58–62.
32. Mahendran P, Vanisree AJ, Devi CS. The antiulcer activity of Garcinia cambogia extract against indomethacin-induced gastric ulcers in rats. Phytother Res. 2002;16:80–83.
33. Bousova I, Bacikova E, Dobrijevic S, Drsata J. Glycation of aspartate aminotransferase by methylglyoxal, effect of hydroxycitric and uric acid. Mol Cell Biol. May 18, 2009; (epub ahead of print).
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35. Heymsfield SB, Allison DB, Vasselli JR, Pietrobelli A, Greenfield D, Nunez C. Garcinia cambogia (Hydroxycitric acid) as a potential antiobesity agent. J Amer Med Assoc. 1998;280:1596–1600.
36. Kriketos AD, Thompson HR, Greene H, Hill JO. (–)-Hydroxycitric acid does not affect energy expenditure and substrate oxidation in adult males in a post-absorptive state. Int J Obes Relat Metab Disorders. 1999;23:867–873.
37. Lim K, Ryu S, Ohishi Y, et al. Shortterm (–)-hydroxycitrate ingestion increases fat oxidation during exercise in athletes. J Nutr Sci Vitaminol. 2002;48:128–133.
38. Lim K, Ryu S, Nho HS, et al.(–)-Hydroxycitric acid ingestion increases fat utilization during exercise in untrained women. J Nutr Sci Vitaminol. 2003;49:163–167.
39. Kovacs EMR, Westerterp-Plantenga MS. Effects of (–)-hydroxycitrate on net fat synthesis as de novo lipogenesis. Physiol Behavior. 2006;88:371–381.
40. Roy S, Rink C, Khanna S, et al. Body weight and abdominal fat gene expression profile in response to a novel hydroxycitric acid based dietary supplement. Gene Express. 2004;11:252–263.

 


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