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Meratrim Venkateshwarlu

Aug 30, 2016 by Jawon Smith Comments: 0

Meratrim® Lipids Health Dis. 2016; 15(1): 136. Efficacy and tolerability of Meratrim for weight management: a randomized, double-blind, placebo-controlled study in healthy overweight human subjects. Venkateshwarlu Kudiganti,1 Raveendra Ramamurthy Kodur,1 Sushma Raveendra Kodur,1 Manjunath Halemane,2 andDheeraj Kumar Deep2 Abstract Background Meratrim is a blend of two plant extracts obtained from Sphaeranthus indicus flower heads and Garcinia mangostana fruit rinds. Previous studies have demonstrated that Meratrim is effective for weight management in obese individuals. The objective of this study was to assess the efficacy and tolerability of Meratrim in managing body weight in healthy overweight subjects. Methods Sixty participants with a mean BMI of 28.3 kg/m2 were randomized into two groups receiving either 400 mg of Meratrim twice daily or two identical placebo capsules for a period of 16 weeks. Subjects were asked to consume about 2,000 kcal/day throughout the study period and walk 5 days a week for 30 min daily. The primary endpoint was defined as the change in body weight from baseline to end of week 16 for the Meratrim group versus placebo. Fifty seven subjects completed the trial. Results At study conclusion, statistically significant reductions in body weight (5.09 vs. 1.1 kg; p < 0.0001), BMI (1.91 vs. 0.43 kg/m2; p < 0.0001), waist (9.97 vs. 3.71 cm; p < 0.001) and […] Read More

Aller-7 Amit 2003

Aller-7® Toxicol Mech Methods. 2003;13(4):253-61. doi: 10.1080/713857188. Safety of a novel botanical extract formula for ameliorating allergic rhinitis. Amit A1, Saxena VS, Pratibha N, Bagchi M, Bagchi D, Stohs SJ. Abstract Allergic rhinitis (also known as hay fever) is the most commonly occurring immunological disorder, and it affects 40 million men, women, and children in the United States. Symptomatically, it is an inflammation and irritation of the mucous membranes that line the nose. Allergy is defined as a state of hypersensitivity or hyperimmunity caused by exposure to a particular antigen (allergen) that results in increased reactivity upon subsequent exposure. A novel botanical formulation, Aller-7/NR-A2, was developed for the treatment of allergic rhinitis; it is a combination of medicinal plant extracts from Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Albizia lebbeck, Piper nigrum, Zingiber officinale, and Piper longum. This novel formulation has demonstrated potent antihistaminic, anti-inflammatory, antispasmodic, antioxidant, and mast-cell-stabilization activities. All of the doses for these toxicity studies were selected according to the guidelines of the Organization for Economic Cooperation and Development, the World Health Organization, and the Environmental Protection Agency. Acute toxicity of Aller-7 was evaluated in Swiss Albino mice at doses of 125, 250, 500, 1000, and 1500 mg/kg. […] Read More

Aller-7 Amit 2005

Aller-7® Toxicol Mech Methods. 2005;15(3):193-204. doi: 10.1080/15376520590945612. Safety of a Novel Botanical Extract Formula for Ameliorating Allergic rhinitis. Part II. Amit A1, Joshua AJ, Bagchi M, Bagchi D. Abstract Abstract Each year more than 50 million Americans suffer from allergic rhinitis, which is a state of hypersensitivity or hyperimmunity. Basically, allergic rhinitis is symptomatically recognized as the inflammation and irritation of the nasal mucosal membranes; sneezing; stuffy/runny nose; nasal congestion; and itchy; watery, and swollen eyes; and defined as a state of hypersensitivity/ hyperimmunity caused by exposure to a particular allergen (antigen) that results in increased reactivity upon subsequent exposure. A novel polyherbal formulation (Aller-7/NR-A2) was developed for the treatment of allergic rhinitis using a unique combination of extracts from seven medicinal plants, including Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Albizia lebbeck, Piper nigrum, Zingiber officinale, and Piper longum. Earlier studies in our laboratories have demonstrated potent antihistaminic, anti-inflammatory, antispasmodic, antioxidant, and mast-cell stabilization activities of Aller-7 in addition to its efficacy in a clinical setting. A series of preliminary toxicological evaluations were also conducted in the past, which demonstrated its safety. In this study, we have conducted further safety studies on Aller-7, including acute oral, acute dermal, acute dermal […] Read More

ChromeMate Deshmukh 2009

ChromeMate® J Inorg Biochem. 2009 Dec;103(12):1755-60. doi: 10.1016/j.jinorgbio.2009.03.008. Epub 2009 May 15. Safety of an oxygen-coordinated niacin-bound chromium(III) complex (NBC): II. Developmental toxicity study in rats. Deshmukh NS1, Bagchi M, Lau FC, Bagchi D. Abstract The objective of the present study was to evaluate the teratogenic potential of a novel oxygen-coordinated niacin-bound chromium complex (NBC) in Sprague-Dawley rats. Due to its potential to affect fat synthesis and reduce food intake, processes which are often crucial in normal fetal development, this teratology study was undertaken as part of a multi-generation reproductive investigation. The animals in this study were selected randomly after weaning from each F(2b) litter of the F1 generation from the two-generation reproductive toxicity study. To start the teratology study, Sprague-Dawley rat pups ( approximately 30/sex/group) from the F(2b) generation were allowed to grow up to 10-12 weeks of age before mating. The rats in treatment group were exposed directly to NBC through feed. The dietary exposure levels were the same as those employed for the two-generation reproductive toxicity study, viz. 4, 15, or 60 ppm. Following mating at maturity, the pregnant rats were observed daily for clinical signs of adverse effects, and body weight and feed consumption were recorded. […] Read More

ChromeMate Deshmukh

ChromeMate® J Inorg Biochem. 2009 Dec;103(12):1748-54. doi: 10.1016/j.jinorgbio.2009.07.014. Epub 2009 Jul 28. Safety of a novel oxygen-coordinated niacin-bound chromium(III) complex (NBC): I. Two-generation reproduction toxicity study. Deshmukh NS1, Bagchi M, Lau FC, Bagchi D. Abstract The objective of this study was to evaluate the effects of a novel oxygen-coordinated niacin-bound chromium(III) complex (NBC) on the reproductive systems of male and female rats, the postnatal maturation and reproductive capacity of their offspring, and possible cumulative effects through multiple generations. Sprague-Dawley rats were maintained on feed containing NBC at dose levels of 0, 4, 15, or 60ppm for 10weeks prior to mating, during mating, and, for females through gestation and lactation, across two generations. For the parents (F(0) and F(1)) and the offspring (F(1) and F(2a)), reproductive parameters such as fertility and mating, gestation, parturition, litters, lactation, sexual maturity and development of offspring were assessed. Results from the current study indicated that dietary exposure of NBC to parental male and female rats of both (F(0) and F(1)) the generations during the premating and mating periods, for both sexes, and during gestation and lactation in case of female rats, did not cause any significant incidence of mortality or abnormal clinical signs. Compared to […] Read More

ChromeMate Shara 2005.2

ChromeMate® Journal of Inorganic Biochemistry, Volume 99, Issue 11, November 2005, Pages 2161–2183 Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex Michael Sharaa, Taharat Yasmina, Anthony E. Kincaida, Aimee L. Limpacha, Jason Bartza, Karrie A. Brennemanb, Archana Chatterjeea, Manashi Bagchic, Sidney J. Stohsa, Debasis Bagchia, c Abstract Chromium is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Niacin-bound chromium (NBC) is a unique form of bioavailable chromium that promotes healthy lipid profile. This study was focused on determining the broad spectrum safety of NBC. Acute oral, acute dermal, primary dermal irritation and primary eye irritation toxicities of NBC were evaluated. Ames bacterial reverse mutation assay, mouse lymphoma test and a dose-dependent 90-day subchronic toxicity were also conducted. In safety studies, the acute oral LD50 of NBC was found to be greater then 5000 mg/kg in both male and female Sprague–Dawley rats. No changes in body weight or adverse effects were observed following necropsy. The acute dermal LD50 of NBC was found to be >2000 mg/kg. The primary skin irritation test was conducted with NBC on New Zealand Albino rabbits. NBC was classified […] Read More

ChromeMate Shara 2005

ChromeMate® J Inorg Biochem. 2005 Nov;99(11):2161-83. Epub 2005 Sep 19. Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex. Shara M1, Yasmin T, Kincaid AE, Limpach AL, Bartz J, Brenneman KA, Chatterjee A, Bagchi M, Stohs SJ, Bagchi D. Abstract Chromium is an essential trace element required for normal protein, fat and carbohydrate metabolism. It also helps in energy production and increasing lean body mass. Niacin-bound chromium (NBC) is a unique form of bioavailable chromium that promotes healthy lipid profile. This study was focused on determining the broad spectrum safety of NBC. Acute oral, acute dermal, primary dermal irritation and primary eye irritation toxicities of NBC were evaluated. Ames bacterial reverse mutation assay, mouse lymphoma test and a dose-dependent 90-day subchronic toxicity were also conducted. In safety studies, the acute oral LD(50) of NBC was found to be greater then 5000 mg/kg in both male and female Sprague-Dawley rats. No changes in body weight or adverse effects were observed following necropsy. The acute dermal LD(50) of NBC was found to be >2000 mg/kg. The primary skin irritation test was conducted with NBC on New Zealand Albino rabbits. NBC was classified as slightly irritating. The primary eye irritation test […] Read More

ChromeMate Shara 2006

ChromeMate® J Inorg Biochem. 2007 Jul;101(7):1059-69. Epub 2007 Apr 19. Long-term safety evaluation of a novel oxygen-coordinated niacin-bound chromium (III) complex. Shara M1, Kincaid AE, Limpach AL, Sandstrom R, Barrett L, Norton N, Bramble JD, Yasmin T, Tran J, Chatterjee A, Bagchi M, Bagchi D. Abstract Chromium (III) is an essential micronutrient required for normal protein, fat and carbohydrate metabolism, as well as helps insulin metabolize fat, turn protein into muscle and convert sugar into energy. A broad spectrum of research investigations including in vitro, in vivo and clinical studies demonstrated the beneficial effects of novel oxygen- coordinated niacin-bound chromium (III) complex (NBC) in promoting glucose-insulin sensitivity, lipid profile, cardioprotective ability and lean body mass. This study examined the long-term safety of NBC by orally administering either 0 or 25 ppm or the human equivalency dose of 1000 microg elemental chromium (III) as NBC per day for 52 consecutive weeks to male and female Sprague-Dawley rats. Animals of each group and each gender were sacrificed on 26, 39, or 52 weeks of treatment. Body weight, physical and ocular health, feed and water intake, selected organ weights as such and as a percentage of liver and brain weight, hepatic lipid peroxidation […] Read More

ChromeMate Shara 2008

ChromeMate® Toxicology Mechanisms and Methods. Volume 16, Issue 8, 2006 Safety Assessment of a Novel Niacin-Bound Chromium-Based Energy Formulation M. A. Sharaa, T. Yasmina, A. Chatterjeea, M. Bagchib, N. Maulikc& D. Bagchiab Abstract Over 35 million adults suffer from fatigue or lack of energy. In this study, we assessed the safety of a novel niacin-bound chromium-based Energy Formulation, which also contained caffeine, D-ribose, Withania somnifera extract, and selected amino acids. Niacin-bound chromium is a novel source of bioavailable chromium (III), and known to promote healthy lipid profile. Male and female Sprague-Dawley rats were fed 125 ppm Energy Formulation for 90 consecutive days. Body weight, feed, and water intake were monitored over the period of 90 days. No significant changes were observed between the control and treatment groups following subchronic supplementation with this Energy Formulation. Furthermore, no significant changes were observed in selected organ weights individually and as percentages of body and brain weights. The Energy Formulation supplementation did not cause changes in hepatic lipid peroxidation or DNA fragmentation after 30, 60, or 90 days of treatment. Hematology, clinical chemistry, and histopathological evaluations revealed no adverse effects in the treatment group. These findings demonstrate the safety of this Energy Formulation. http://www.tandfonline.com/doi/abs/10.1080/15376520600709746 Read More

Meratrim Saiyed

Meratrim® Food Chem Toxicol. 2015 Apr;78:122-9. doi: 10.1016/j.fct.2015.02.010. Epub 2015 Feb 11. Safety and toxicological evaluation of Meratrim®: an herbal formulation for weight management. Saiyed ZM1, Sengupta K2, Krishnaraju AV2, Trimurtulu G2, Lau FC1, Lugo JP3. Abstract Meratrim is a unique dietary ingredient consisting of extracts from Sphaeranthus indicus flower heads and Garcinia mangostana fruit rind. Clinical studies have demonstrated that Meratrim is effective and well-tolerated in weight management. Herein we assessed the broad spectrum safety of Meratrim in a battery of in vitro and animal toxicological studies including a sub-chronic repeated-dose 13-week oral toxicity study to determine the no-observable-adverse-effect-level (NOAEL). The LD50 levels of Meratrim in Sprague-Dawley (SD) rats, as determined by the acute oral and dermal toxicity studies, were >5000 and >2000 mg/kg body weight, respectively. The primary skin and eye irritation tests classified Meratrim as non-irritating to the skin and mildly irritating to the eye. Genotoxicity studies showed that Meratrim is non-mutagenic. In the repeated-dose 13-week oral toxicity study, SD rats were orally gavaged with Meratrim at 0, 250, 500 or 1000 mg/kg/day. No morbidity, mortality, or significant adverse events were observed either during the course of the study or on the 13th week. The NOAEL of Meratrim was […] Read More