Research Articles


CarbMelt's Ingredients Have Been Well Documented and Researched.

Below is a sample of research documentation by peer reviewed scientists from around the world that reveal how CarbMelt and BellyMelt's ingredients are tested and proven to help you lose weight and feel better!

CarbMelt Research Documentation and Sources

White Kidney Bean Extract

     Carbohydrates are often maligned for those trying to lose weight. Yet, avoiding starchy foods is very difficult for many individuals. Complex carbohydrates are an important nutritional component of a healthy diet that adds dietary fiber, B vitamins, and trace elements. Diets too low in carbohydrates can depress serotonin levels and mood. Too often, people resort to fatty or sugary foods to feel satiated. With CarbMelt™, individuals can eat bread, pasta, rice, potatoes, and other complex carbohydrates as part of a balanced diet, yet limit their caloric contribution.

    CarbMelt™ contains Phase 2 Starch Neutralizer®, a non-stimulant extract from the white kidney bean, Phaseolus vulgaris, that may reduce the enzymatic digestion of dietary starches. Phase 2 Starch Neutralizer® is supported by clinical investigations and preclinical studies demonstrating its mode of action. Two capsules of CarbMelt™ at least twice a day, taken with starchy meals or a snack, may assist in weight control when used in conjunction with a sensible diet and exercise program.
     The common white bean (Phaseolus vulgaris) produces an alpha-amylase inhibitor, which has been characterized and tested in numerous clinical studies. A specific and proprietary product named Phase 2® Carb Controller (Pharmachem Laboratories, Kearny, NJ) has demonstrated the ability to cause weight loss with doses of 500 to 3000 mg per day, in either a single dose or in divided doses.
Regular intake of white kidney beans extract (Phaseoulus vulgaris L.) induces weight loss compared to placebo in obese human subjects:
Result and conclusion: As a result, the average amount of weight lost by the Phaseolus vulgaris extract group was 2.24 kg (average of 0.448 kg per week), compared with a 0.29 kg weight loss (average of 0.058 kg per week) in placebo group after 35 days. The differences between groups were significant (p < .01). The body mass index decreased by an average of 0.79, and the body fat decreased by 1.53% on average compared to baseline (p < .05). The thickness of subcutaneous fat was significantly reduced at the four measurement points, and the decrease of waist circumference and hip circumference was significant as well. No adverse or side effects were observed during the trial period. The results indicate that Phaseolus vulgaris extract can significantly induce weight loss in a short time period.
Vitamin B12:
 Vitamins and minerals are essential to humans as they play essential roles in a variety of basic metabolic pathways that support fundamental cellular functions. In particular, their involvement in energy-yielding metabolism, DNA synthesis, oxygen transport, and neuronal functions makes them critical for brain and muscular function. These, in turn, translate into effects on cognitive and psychological processes, including mental and physical fatigue.
     This review is focused on B vitamins (B1, B2, B3, B5, B6, B8, B9 and B12), vitamin C, iron, magnesium and zinc, which have recognized roles in these outcomes. It summarizes the biochemical bases and actions of these micronutrients at both the molecular and cellular levels and connects them with cognitive and psychological symptoms, as well as manifestations of fatigue that may occur when status or supplies of these micronutrients are not adequate.
Magnesium (for blood sugar balance coinciding with insulin resistance):
To the best our knowledge, data on the effects of magnesium-zinc-calcium-vitamin D co-supplementation on glycemic control and markers of cardiometabolic risk in gestational diabetes mellitus (GDM) are scarce. The purpose of this study was to establish the effects of magnesium-zinc-calcium-vitamin D co-supplementation on glycemic control and markers of cardiometabolic risk of GDM patients. Sixty patients with GDM, aged 18-40 years, were randomized into 2 groups to intake either magnesium-zinc-calcium-vitamin D co-supplements or placebo (n = 30 each group) for 6 weeks in a randomized, double-blind, placebo-controlled trial.
     Fasting blood samples were taken at baseline and week 6 to quantify related markers. After the 6-week intervention, compared with the placebo, magnesium-zinc-calcium-vitamin D co-supplementation resulted in significant reductions in fasting plasma glucose (-0.37 ± 0.09 vs. +0.01 ± 0.09 mmol/L, P = 0.003), serum insulin levels (-21.0 ± 4.8 vs. +7.2 ± 4.8 pmol/L, P < 0.001), homeostatic model of assessment for insulin resistance (-1.0 ± 1.1 vs. +0.3 ± 1.3, P < 0.001), and a significant increase in quantitative insulin sensitivity check index (+0.02 ± 0.03 vs. -0.002 ± 0.03, P = 0.003). In addition, magnesium-zinc-calcium-vitamin D co-supplementation significantly decreased serum triglycerides (-0.25 ± 0.10 vs. +0.34 ± 0.10 mmol/L, P = 0.001) and very-low-density-cholesterol concentrations (-0.11 ± 0.04 vs. +0.15 ± 0.04 mmol/L, P = 0.001) compared with the placebo. Overall, the results of this study demonstrated that magnesium-zinc-calcium-vitamin D co-supplementation for 6 weeks among patients with GDM had beneficial effects on glycemic control and few markers of cardiometabolic risk.

Chromium (Body Composition Changes in Weight Loss: Strategies and Supplementation for Maintaining Lean Body Mass, a Brief Review

Darryn Willoughby  1 , Susan Hewlings  2   3 , Douglas Kalman  4   5
 PMID: 30513859 PMCID:
With over two-thirds (71.6%) of the US adult population either overweight or obese, many strategies have been suggested for weight loss. While many are successful, the weight loss is often accompanied by a loss in lean body mass. This loss in lean body mass has multiple negative health implications. Therefore, weight loss strategies that protect lean body mass are of value. It is challenging to consume a significant caloric deficit while maintaining lean body mass regardless of macronutrient distribution. Therefore, the efficacy of various dietary supplements on body weight and body composition have been a topic of research interest.
     Chromium picolinate has been shown to improve body composition by maintaining lean body mass. In this paper we review some common weight loss strategies and dietary supplements with a focus on their impact on body composition and compare them to the effect of chromium picolinate.
Salatia Reticulata (Has Therapeutic Effects on Obesity):
     2014 Oct;68(4):668-76. doi: 10.1007/s11418-014-0845-9. Epub 2014 May 18.
     Tsutomu Shimada  1 , Yuichiro Nakayama, Yukiko Harasawa, Hirofumi Matsui, Hiroko Kobayashi, Yoshimichi Sai, Ken-ichi Miyamoto, Shunji Tomatsu, Masaki Aburada
      PMID: 24838513 DOI: 10.1007/s11418-014-0845-9
     Salacia reticulata Wight (S. reticulata) is a herbal medicine used for treatment of early diabetes in Ayurvedic medicine. In previous reports, the extract of S. reticulata showed preventive effects on obesity and various metabolic disorders and a suppressive effect on differentiation in premature adipocytes. The aim of this research was to elucidate the therapeutic efficacy of the extract of S. reticulata on obesity and various metabolic disorders in 12-week-old TSOD mice with obesity and metabolic disorders and in mature 3T3-L1 adipocytes. In TSOD mice, S. reticulata therapy produced a reduction in body weight and mesenteric fat accumulation, an improvement in abnormal glucose metabolism, and an increase in adiponectin level in plasma. In addition, the mRNA expressions of hormone-sensitive lipase (HSL) and adiponectin were increased in mesenteric fat. In in vitro experiments, S. reticulata therapy produced suppression of intracellular triacylglycerol accumulation and enhancement of glycerol release into the medium in mature 3T3-L1 cells. The mRNA expressions of lipogenesis factor (peroxisome proliferator-activated receptor γ, lipoprotein lipase, CD36, and fatty acid binding protein 4) were down-regulated, while the expressions of lipolysis factor (adipose tissue triacylglycerol lipase and HSL) and adiponectin were up-regulated. Moreover, the extract of S. reticulata enhanced the expression of total AMP-activated protein kinase α (AMPKα) and phosphorylated AMPKα in mature adipocytes. These findings demonstrate that the extract of S. reticulata has therapeutic effects on obesity and metabolic disorders by enhancing lipogenesis genes and suppressing lipolysis genes through the activation of AMPKα in adipocytes.
     Similar articles
     Salacia reticulata (Kothala himbutu) revisited; a missed opportunity to treat diabetes and obesity? Medagama AB.
Nutr J. 2015 Feb 27;14:21. doi: 10.1186/s12937-015-0013-4.
PMID: 25889885 Free PMC article. Review. 
     Salacia reticulata inhibits differentiation of 3T3-L1 adipocytes. Shimada T, Nagai E, Harasawa Y, Watanabe M, Negishi K, Akase T, Sai Y, Miyamoto K, Aburada M.
J Ethnopharmacol. 2011 Jun 14;136(1):67-74. doi: 10.1016/j.jep.2011.04.012. Epub 2011 Apr 12.
PMID: 21511020 
     Metabolic disease prevention and suppression of fat accumulation by Salacia reticulata. Shimada T, Nagai E, Harasawa Y, Akase T, Aburada T, Iizuka S, Miyamoto K, Aburada M.
J Nat Med. 2010 Jul;64(3):266-74. doi: 10.1007/s11418-010-0401-1. Epub 2010 Mar 12.
PMID: 20225078 
     Korean Chungtaejeon tea extract attenuates body weight gain in C57BL/6J-Lep ob/ob mice and regulates adipogenesis and lipolysis in 3T3-L1 adipocytes. Sharma BR, Kim DW, Rhyu DY.
J Integr Med. 2017 Jan;15(1):56-63. doi: 10.1016/S2095-4964(17)60321-2.
PMID: 28088260 
     Metabolism of lipids in human white adipocyte. Large V, Peroni O, Letexier D, Ray H, Beylot M.
Diabetes Metab. 2004 Sep;30(4):294-309. doi: 10.1016/s1262-3636(07)70121-0.
PMID: 15525872 Review.
Fennel Seed Powder (Fennel (Foeniculum vulgare) and Fenugreek (Trigonella foenum-graecum) Tea Drinking Suppress Subjective Short-term Appetite in Overweight Women - Ji Young Bae, 1 Ji Eun Kim, 1 Ryowon Choue
 Appetite controlling has been a main strategy for regulating food intake and energy balance in obesity treatment. The aim of this study was to examine the effects of drinking tea of the medicinal herbs, fennel and fenugreek, on the subjective appetite in overweight Korean women. The study was conducted using a placebo-controlled, single-blinded, randomized, and 3-way crossover design. Nine healthy women were given fennel tea (FT), fenugreek tea (FGT), or placebo tea (PT). After drinking a given tea, a lunch buffet was provided and then food consumption of subjects was analyzed. Subjective appetite, hunger, fullness, desire to eat, and prospective food consumption were measured at seven independent time point using a visual analog scale (VAS). Mean age of 9 subjects were 49.7 ± 4.5 years and their mean body mass index were 24.6 ± 0.6 kg/m2. There was no significant difference in food consumption in the lunch buffet after drinking each tea; however, with respect to the subjective appetite scale, FGT decreased hunger, led to less prospective food consumption, and increased feelings of fullness compared with the PT (p < 0.05). Similarly, the consumption of FT resulted in decreased hunger, less prospective food consumption, and increased feelings of fullness compared with the PT (p < 0.05). The area under the curve of VAS graph indicated that FGT resulted in a higher feeling of fullness than the PT (p < 0.05). In conclusion, drinking the FT and FGT were significantly effective aid to suppress subjective appetite among overweight women in South Korea.

Raspberry Ketones
Anti-obese action of raspberry ketone
Chie Morimoto  1 , Yurie Satoh, Mariko Hara, Shintaro Inoue, Takahiro Tsujita, Hiromichi Okuda
PMID: 15862604 DOI: 10.1016/j.lfs.2004.12.029

 Raspberry ketone (4-(4-hydroxyphenyl) butan-2-one; RK) is a major aromatic compound of red raspberry (Rubus idaeus). The structure of RK is similar to the structures of capsaicin and synephrine, compounds known to exert anti-obese actions and alter the lipid metabolism. The present study was performed to clarify whether RK helps prevent obesity and activate lipid metabolism in rodents. To test the effect on obesity, our group designed the following in vivo experiments: 1) mice were fed a high-fat diet including 0.5, 1, or 2% of RK for 10 weeks; 2) mice were given a high-fat diet for 6 weeks and subsequently fed the same high-fat diet containing 1% RK for the next 5 weeks. RK prevented the high-fat-diet-induced elevations in body weight and the weights of the liver and visceral adipose tissues (epididymal, retroperitoneal, and mesenteric). RK also decreased these weights and hepatic triacylglycerol content after they had been increased by a high-fat diet. RK significantly increased norepinephrine-induced lipolysis associated with the translocation of hormone-sensitive lipase from the cytosol to lipid droplets in rat epididymal fat cells. In conclusion, RK prevents and improves obesity and fatty liver. These effects appear to stem from the action of RK in altering the lipid metabolism, or more specifically, in increasing norepinephrine-induced lipolysis.

Berberine (The effect of Berberine on weight loss in order to prevent obesity: A systematic review
Zahra Ilyas  1 , Simone Perna  1 , Salwa Al-Thawadi  1 , Tariq A Alalwan  1 , Antonella Riva  2 , Giovanna Petrangolini  2 , Clara Gasparri  3 , Vittoria Infantino  4 , Gabriella Peroni  5 , Mariangela Rondanelli  6
 PMID: 32353823 DOI: 10.1016/j.biopha.2020.110137
   This study provides a critical overview of experimental studies in vitro, in humans, and in animals that evaluated the efficacy of Berberine and its effect on management of obesity and the related metabolic consequences. As a result of this review, we summarized the effects of Berberine in different models and the related mechanism of actions. In preclinical models, Berberine demonstrates that it affects gut microbiota by reducing diversity of microbes starting at a dosage of 100 mg/kg/day. Moreover, in animal models, Berberine explicates an action on glucose through the inhibition of α-glycosidase at a dose of 200 mh/kg/day. Berberine is also known to be effective against differentiation of adipocytes through a decrease in LXRs, PPARs, and SREBPs expression at 150 mg/kg/day. Other mechanism ascribed to Berberine are related to its inhibition of hepatic gluconeogenesis through the Phospheoenolpyruvate carboxykinase (PEPCK), Glucose-6-phosphate (G6Pase) and AMP-activated protein kinase (AMPK).
     Furthermore, Berberine (associated to Red Yeast Rice) is effective in decreasing lipid levels in rats, which consequently lowers the change of weight gain at dosage of 40 mg/kg to 380 mg/kg/day. All the above preclinical data are confirmed in human studies where Berberine can modulate the diversity of gut microbes at the dose of 500 mg/day. In addition, Berberine is found to have a beneficial impact on gene regulation for the absorption of cholesterol at a daily dose of 300 mg in humans, an amelioration on glucose accumulation at 1.0 g daily dose was also observed. 
     For all these reasons, this review gives an important good account of the impact of Berberine in obesity treatment and prevention.
Green Tea Caffeine and Catechins (Body weight loss and weight maintenance in relation to habitual caffeine intake and green tea supplementation)
Margriet S Westerterp-Plantenga  1 , Manuela P G M Lejeune, Eva M R Kovacs
Affiliations expand
PMID: 16076989 DOI: 10.1038/oby.2005.142
Objective: Investigation of the effect of a green tea-caffeine mixture on weight maintenance after body weight loss in moderately obese subjects in relation to habitual caffeine intake.

     Research methods and procedures: A randomized placebo-controlled double blind parallel trial in 76 overweight and moderately obese subjects, (BMI, 27.5 +/- 2.7 kg/m2) matched for sex, age, BMI, height, body mass, and habitual caffeine intake was conducted. A very low energy diet intervention during 4 weeks was followed by 3 months of weight maintenance (WM); during the WM period, the subjects received a green tea-caffeine mixture (270 mg epigallocatechin gallate + 150 mg caffeine per day) or placebo.
     Results: Subjects lost 5.9 +/-1.8 (SD) kg (7.0 +/- 2.1%) of body weight (p < 0.001). At baseline, satiety was positively, and in women, leptin was inversely, related to subjects' habitual caffeine consumption (p < 0.01). High caffeine consumers reduced weight, fat mass, and waist circumference more than low caffeine consumers; resting energy expenditure was reduced less and respiratory quotient was reduced more during weight loss (p < 0.01). In the low caffeine consumers, during WM, green tea still reduced body weight, waist, respiratory quotient and body fat, whereas resting energy expenditure was increased compared with a restoration of these variables with placebo (p < 0.01). In the high caffeine consumers, no effects of the green tea-caffeine mixture were observed during WM.
     Discussion: High caffeine intake was associated with weight loss through thermogenesis and fat oxidation and with suppressed leptin in women. In habitual low caffeine consumers, the green tea-caffeine mixture improved WM, partly through thermogenesis and fat oxidation.
Citrus aurantium and Rhodiola rosea in combination reduce visceral white adipose tissue and increase hypothalamic norepinephrine in a rat model of diet-induced obesity
     Jessica L. Verpeut,a,b Amy L. Walters,a and Nicholas T. Belloa,b,*
     Author information Copyright and License information 
     Extracts from the immature fruit of Citrus aurantium are often used for weight loss but are reported to produce adverse cardiovascular effects. Root extracts of Rhodiola rosea have notable antistress properties. The hypothesis of these studies was that C aurantium (6% synephrine) and R rosea (3% rosavins, 1% salidroside) in combination would improve diet-induced obesity alterations in adult male Sprague-Dawley rats. In normal-weight animals fed standard chow, acute administration of C aurantium (1-10 mg/kg) or R rosea (2-20 mg/kg) alone did not reduce deprivation-induced food intake, but C aurantium (5.6 mg/kg) + R rosea (20 mg/kg) produced a 10.5% feeding suppression. Animals maintained (13 weeks) on a high-fat diet (60% fat) were exposed to 10-day treatments of C aurantium (5.6 mg/kg) or R rosea (20 mg/kg) alone or in combination. Additional groups received vehicle (2% ethanol) or were pair fed to the C aurantium + R rosea group. Although high-fat diet intake and weight loss were not influenced, C aurantium + R rosea had a 30% decrease in visceral fat weight compared with the other treatments. Only the C aurantium group had an increased heart rate (+7%) compared with vehicle. In addition, C aurantium + R rosea administration resulted in an elevation (+15%) in hypothalamic norepinephrine and an elevation (+150%) in frontal cortex dopamine compared with the pair-fed group. These initial findings suggest that treatments of C aurantium + R rosea have actions on central monoamine pathways and have the potential to be beneficial for the treatment of obesity.
5-HTP (serotonin precursor) (Serotonin reciprocally regulates melanocortin neurons to modulate food intake
Lora K Heisler  1 , Erin E Jobst, Gregory M Sutton, Ligang Zhou, Erzsebet Borok, Zoe Thornton-Jones, Hong Yan Liu, Jeffrey M Zigman, Nina Balthasar, Toshiro Kishi, Charlotte E Lee, Carl J Aschkenasi, Chen-Yu Zhang, Jia Yu, Olivier Boss, Kathleen G Mountjoy, Peter G Clifton, Bradford B Lowell, Jeffrey M Friedman, Tamas Horvath, Andrew A Butler, Joel K Elmquist, Michael A Cowley):


     The neural pathways through which central serotonergic systems regulate food intake and body weight remain to be fully elucidated. We report that serotonin, via action at serotonin1B receptors (5-HT1BRs), modulates the endogenous release of both agonists and antagonists of the melanocortin receptors, which are a core component of the central circuitry controlling body weight homeostasis. We also show that serotonin-induced hypophagia requires downstream activation of melanocortin 4, but not melanocortin 3, receptors. These results identify a primary mechanism underlying the serotonergic regulation of energy balance and provide an example of a centrally derived signal that reciprocally regulates melanocortin receptor agonists and antagonists in a similar manner to peripheral adiposity signals.

Brain serotonin, carbohydrate-craving, obesity and depression

R J Wurtman  1 , J J Wurtman
Affiliations expand
PMID: 8697046 DOI: 10.1002/j.1550-8528.1995.tb00215.x
Serotonin-releasing brain neurons are unique in that the amount of neurotransmitter they release is normally controlled by food intake: Carbohydrate consumption--acting via insulin secretion and the "plasma tryptophan ratio"--increases serotonin release; protein intake lacks this effect. This ability of neurons to couple neuronal signaling properties to food consumption is a link in the feedback mechanism that normally keeps carbohydrate and protein intakes more or less constant. However, serotonin release is also involved in such functions as sleep onset, pain sensitivity, blood pressure regulation, and control of the mood. Hence many patients learn to overeat carbohydrates (particularly snack foods, like potato chips or pastries, which are rich in carbohydrates and fats) to make themselves feel better. This tendency to use certain foods as though they were drugs is a frequent cause of weight gain, and can also be seen in patients who become fat when exposed to stress, or in women with premenstrual syndrome, or in patients with "winter depression," or in people who are attempting to give up smoking. (Nicotine, like dietary carbohydrates, increases brain serotonin secretion; nicotine withdrawal has the opposite effect.) It also occurs in patients with normal-weight bulimia. Dexfenfluramine constitutes a highly effective treatment for such patients. In addition to producing its general satiety-promoting effect, it specifically reduces their overconsumption of carbohydrate-rich (or carbohydrate-and fat-rich) foods.

BellyMelt Research Documentation and Sources

Licorice Root (Licorice Flavonoid Oil Effects Body Weight Loss by Reduction of Body Fat Mass in Overweight Subjects)

Yuji Tominaga, Tatsumasa Mae, Mitsuaki Kitano, Yoshiro Sakamoto, Hideyuki Ikematsu, Kaku Nakagawa
2006 Volume 52 Issue 6 Pages 672-683
     Licorice flavonoid oil (LFO) is a new dietary ingredient for functional foods consisting of licorice hydrophobic polyphenols in medium-chain triglycerides (MCT). In an effective dose finding study conducted previously, LFO has exhibited a dose-dependent body fat-reducing effect. Here we report the weight-reducing effect of LFO in a placebo-controlled, double-blind, long-term (12 weeks) ingestion study at 300 mg/day, the minimal effective dose observed in the dose finding study. A total of 103 overweight subjects [body mass index (BMI): 24-30] completed this study and were analyzed. Body weight increased in the placebo group, but was maintained at close to pre-ingestion level in the LFO group, resulting in significant (p < 0.05) differences in the changes in body weight and BMI between the LFO group and the placebo group at each time-point. Dual-energy X-ray absorptiometry (DXA) measurement of body fat indicated that the weight-reducing effect was attributable to reduced body fat. No clinically significant adverse events occurred during the 12-week ingestion period. To confirm the safety of LFO for practical use we also conducted a placebo-controlled, double-blind safety study in 40 overweight subjects with a 4-week excessive ingestion at 1800 mg/day; 6 times the dose of the 300 mg/day study that exhibited a weight-reducing effect. No clinically significant adverse events occurred during the 4-week ingestion period. Based on these findings in both human studies it was shown that LFO is a safe ingredient for functional foods even for long-term or excessive ingestion, with a potential weight-reducing effect. 
Dietary licorice root supplementation improves diet-induced weight gain, lipid deposition and hepatic steatosis in ovariectomized mice without stimulating reproductive tissues and mammary gland.
     Zeynep Madak Erdogan,1 Ping Gong,2 Yiru Chen Zhao,2 Liwen Xu,2 Kinga U. Wrobel,1 James A. Hartman,1 Michelle Wang,1 Anthony Cam,1 Urszula T. Iwaniec,4 Russell T. Turner,4 Nathan C. Twaddle,5 Daniel R. Doerge,5 Ikhlas A. Khan,6,7 John A. Katzenellenbogen,3 Benita S. Katzenellenbogen,2 and William G. Helferich1
     We studied the impact of dietary supplementation with licorice root components on diet-induced obesity, fat accumulation and hepatic steatosis in ovariectomized C57BL/6 mice as a menopause model.
Materials and Methods.
     We evaluated the molecular and physiological effects of dietary licorice root administered to ovariectomized C57BL/6 mice as root powder (LRP), extracts (LRE) or isolated isoliquiritegenin (ILQ) on reproductive (uterus and mammary gland) and non-reproductive tissues important in regulating metabolism (liver, perigonadal, perirenal, mesenteric and subcutaneous fat). Quantitative outcome measures including body weight, fat distribution (MRI), food consumption, bone density and weight (DXA) and gene expression were assessed by the degree of restoration to the premenopausal health state. We characterized histological (H&E and oil red O staining) and molecular properties (expression of certain disease markers) of these tissues, and correlated these with metabolic phenotype as well as blood levels of bioactives.
     Although LRE and ILQ provided some benefit, LRP was the most effective in reducing body weight gain, overall fat deposition, liver steatosis, and expression of hepatic lipid synthesis genes following ovariectomy. Our data demonstrate that licorice root provided improvement of multiple metabolic parameters under conditions of menopausal low estrogen and high-fat diets without stimulating reproductive tissues.

Chitosan (Single-blind, placebo controlled randomised clinical study of chitosan for body weight reduction

 VR Trivedi, MC Satia, A. Deschamps, V. Maquet, RB Shah, PH Zinzuwadia & JV Trivedi Nutrition Journal volume
 15, Article number: 3 (2015)):
 Chitosan is a dietary fibre which acts by reducing fat absorption and thus used as a means for controlling weight. Weight loss clinical trial outcomes, however, have contradictory results regarding its efficacy. The primary objective of the present study was to evaluate the efficacy and safety of a chitosan from fungal origin in treatment of excess weight in the absence of dietary restrictions.

     A phase IV, randomised, multicentre, single-blind, placebo-controlled, clinical study was conducted by administering chitosan capsules (500 mg, five/day) and indistinguishable placebo capsules as daily supplements to 96 overweight and obese subjects for 90 days. The study participants were divided in 2:1 ratio to receive either chitosan (n = 64) or placebo (n = 32). Efficacy was assessed by measuring body weight, body composition parameters, anthropometric measurements, HbA1C level and lipid profile at day 45 and day 90. Also, short form-36 quality of life (QoL) questionnaire was assessed to evaluate improvement in life-style and dietary habits were recorded for calorie intake. Safety was assessed by evaluating safety parameters and monitoring adverse events.
     The mean changes in body weight were -1.78 ± 1.37 kg and -3.10 ± 1.95 kg at day 45 and day 90 respectively in chitosan group which were significantly different (p < 0.0001) as compared to placebo. BMI was decreased by10.91 fold compared to placebo after 90 day administration. In concert with this, there was also reduction in body composition and anthropometric parameters together with improvement in QoL score. Chitosan was also able to reduce HbA1C levels (below 6 %) in subjects who had initial higher values. The mean caloric intake shows that there was no change in dietary habits of subjects in both groups. Lipid levels were unaffected and all adverse events were mild in nature and unrelated to study treatment.
     Chitosan from fungal origin was able to reduce the mean body weight up to 3 kg during the 90 day study period. Together with this, there was also improvement in body composition, anthropometric parameters and HbA1C, reflecting overall benefits for the overweight individuals. Additionally, there was also improvement in QoL score. It was safe and well tolerated by all subjects.
Vanadium (Vanadyl Sulfate Effects on Systemic Profiles of Metabolic Syndrome in Old Rats with Fructose Induced Obesity)
Diego Ortega-Pacheco,1 María Marcela Jiménez-Pérez,2 Jeanet Serafín-López,3 Juan Gabriel Juárez-Rojas,4 Arturo Ruiz-García,2 and Ursino Pacheco-García2
1Universidad de la Sierra Sur, Miahuatlán city, State of Oaxaca, Mexico
2Renal PathophysiologyLaboratory, Department of Nephrology, Instituto Nacional de Cardiología “Ignacio Chávez”, Mexico City, Mexico
3Departament of Immunology, Escuela Nacional de Ciencias Biológicas (ENCB), Instituto Politécnico Nacional (IPN), Mexico City, Mexico
4Department of Endocrinology, Instituto Nacional de Cardiología “Ignacio Chávez”, Mexico City, Mexico
Academic Editor: Fatchiyah Fatchiyah
Received - 06 Jul 2018 - Revised - 23 Sep 2018 - Accepted - 15 Oct 2018 - Published 25 Dec 2018
Background. Currently, energy obtained from hypercaloric diets has been part of the obesity and type 2 diabetes mellitus (T2DM) epidemics from childhood to old age. Treatment alternatives have been sought from plants, minerals, and trace elements with metabolic effects. Vanadyl sulfate (VS) has been investigated as a hypoglycemic compound in animal and human studies showing effective insulin-mimetic properties. This characteristic encompasses several molecules that have beneficial pleiotropic effects. The aim was to determine the antiobesity, hypoglycemic, and hypolipidemic effects of VS on fructose-induced metabolic syndrome in aged rats. Material and Methods. Five groups of male Wistar rats were made, each with six rats: two groups with normal diet (ND) and three with high-fructose diet (HFD). The first ND group was treated with saline solution (SS), the second with VS; treatment for HFD groups was in the first group with SS, second with VS, and third with metformin. Weight, body mass index (BMI), blood glucose, and lipidic profile were measured; water, food, fructose and energy consumption were also determined.
     All parameters were compared among groups. Results and Discussion. Although obese rats treated with VS presented anorexia, oligodipsia, and a marked weight loss in the first two weeks. They recovered food and water intake in the third week with a slow recovery of some weight weeks later. VS normalized blood glucose level and decreased triglyceride and insulin levels in obese rats. These results suggest that vanadyl sulfate shows antiobesity, hypoglycemic, and hypolipidemic properties in old obese rats and could be useful as an alternative, additional, and potent preventive treatment for obesity and T2DM control in elderly obese and poorly controlled diabetic patients. Conclusion. VS could play an important role in the treatment of metabolic syndrome, contributing to a decrease in obesity and T2DM, through different ways, such as euglycemia, satiety, weight loss, and lipid profile optimization, among others. However, more research is needed to confirm this suggestion.

Banaba Leaf Extract (Antiobesity activity of extracts from Lagerstroemia speciosa L. leaves on female KK-Ay Mice)

J Nutr Sci Vitaminol (Tokyo)
1999 Dec;45(6):791-5. doi: 10.3177/jnsv.45.791.
Antiobesity activity of extracts from Lagerstroemia speciosa L. leaves on female KK-Ay mice
Y Suzuki  1 , T Unno, M Ushitani, K Hayashi, T Kakuda
PMID: 10737232 DOI: 10.3177/jnsv.45.791
Banaba in the Tagalog name, Lagerstroemia speciosa L., has been used as a folk medicine for a long time among diabetics in the Philippines. Extracts from banaba leaves have been reported to reduce diabetic symptoms in genetically diabetic mice (Type II, KK-Ay). In the present study, female mice of the same strain showing remarkable body weight gain were used to examine the antiobesity effect of dietary banaba extract. Five-week-old female KK-Ay mice were fed a control diet or test diet containing 5% of a hot-water extract from banaba leaves instead of cellulose for 12 wk. Neither group showed any changes in diet intake during the experimental period. Body weight gain and parametrial adipose tissue weight were lowered significantly in the banaba diet group. Blood glucose levels were not suppressed in the banaba diet group, but hemoglobin A1C was found to be suppressed at the end of the experiment. No effects on the serum lipids were observed, but the mice fed banaba extract showed a significant decrease, to 65% of the control level in total hepatic lipid contents. This decrease was due to a reduction in the accumulation of triglyceride. These results suggest that banaba had a beneficial effect on obese female KK-Ay mice.

Gymnema Sylvester

 Gymnema sylvestre R. BR. (Asclepiadaceae) has been used frequently in traditional Indian folk medicine for the treatment of diabetes. Study was performed in high fat diet (HFD)-induced obesity in murine model. Obesity was induced by oral feeding of HFD for 28 days. The anti obesity effect of water soluble fraction of Gymnema sylvestre extract (120 mg/kg, p.o. for 21 days) in HFD fed rats was evaluated by the measurement of body weight gain, food intake, hemodynamic changes (systolic, diastolic, mean blood pressure and heart rate), serum lipid profiles (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), leptin, insulin, glucose, apolipoproteins A1 and B, lactate dehydrogenase (LDH) and antioxidant enzymes such as reduced glutathione (GSH), glutathione peroxidase (GPx), glutathione reductase (GR), glutathione-S transferase (GST), superoxide dismutase (SOD) and catalase (CAT) levels in liver tissues. Organs and visceral fat pad weight were measured. Histopathological studies were also carried out. Water soluble fraction of G. sylvestre ethanolic extract and rimonabant significantly reduced serum lipids, leptin, insulin, glucose, apolipoprotein B and LDH levels while it significantly increased the HDL-cholesterol, apolipoprotein A1 and antioxidant enzymes levels in liver tissue as compared to the HFD fed rats. Histopathological studies of tissues showed no pathological changes. The results of this study show that water soluble fraction of G. sylvestre extract possess antiobesity effect.

Decreased bodyweight without rebound and regulated lipoprotein metabolism by gymnemate in genetic multifactor syndrome animal
     Hong Luo, Akiko Kashiwagi, Toshiyuki Shibahara & Kazuo Yamada 
     Molecular and Cellular Biochemistry
     Volume 299, pages 93–98(2007)Cite this article
     Objective: The aim of this work was to find obesity control method without rebound. In our previous studies, gymnemate extracted from Gymnema sylvestre, inhibited oleic acid absorption. The Otsuka Long-Evans Tokushima Fatty (OLETF) rat, a genetic multifactor syndrome model, exhibits progressive overweight, hyperlipidemia and hyperglycemia. The effect of gymnemate on obesity in OLETF was investigated. Methods: Three groups were divided (n = 4–8): (1) OLETF-gymnemate, gymnema water extract (containing gymnemate) diet (62.5 g/kg) and water (2.5 g/kg) were supplied 2 weeks from 26–28 weeks, following it general diet and water were fed 3 weeks to observe if it rebound, (2) OLETF-control and (3) the counterpart Long-Evans Tokushima Otsuka rats as normal-control. Results: With gymnemate treatment, the food and water intake were decreased about 1/3 and 2/3, along with body weight reduced 57.2± 6.4 and 75.5± 6.3 g during 1 and 2 weeks respectively. In the end of experiment (3 weeks after gymnemate withdrawal), the body weight was decreased to no significant difference with normal-control. The total cholesterol was decreased about 1/3, moreover LDL+VLDL (low-density and very-low-density lipoprotein) cholesterol decreased about 1/2. The proportion of HDL (high-density lipoprotein) cholesterol to the total cholesterol was increased. The serum triglyceride was decreased to the 1/4 of OLETF control. The level of serum cholesterol and triglyceride was no significant difference in gymnemate group with normal group. Conclusion: Supplementation with gymnemate promotled weight loss by its ability to reduce hyperlipidemia, which was no withdrawal rebound: an important discovery. Supplementation with gymnemate is a novel therapeutic tool for weight management, especially in multifactor syndrome.

Glucomannan (Effect of glucomannan on obese patients: a clinical study)

J Obes Effect of glucomannan on obese patients: a clinical study
D E Walsh, V Yaghoubian, A Behforooz
PMID: 6096282
 An eight-week double-blind trial was conducted to test purified glucomannan fiber as a food supplement in 20 obese subjects. Glucomannan fiber (from konjac root) or placebo was given in 1-g doses (two 500 mg capsules) with 8 oz water, 1 h prior to each of three meals per d. Subjects were instructed not to change their eating or exercise patterns. Results showed a significant mean weight loss (5.5 lbs) using glucomannan over an eight-week period. Serum cholesterol and low-density lipoprotein cholesterol were significantly reduced (21.7 and 15.0 mg/dl respectively) in the glucomannan treated group. No adverse reactions to glucomannan were reported.

Green Tea Natural Caffeine (The anti-obesity effects of green tea in human intervention and basic molecular studies)

Published: 30 July 2014
J Huang, Y Wang, Z Xie, Y Zhou, Y Zhang & X Wan 
European Journal of Clinical Nutrition
volume 68, pages 1075–1087 (2014)
     Many researchers have reported that obesity is a major risk factor for diabetes, cardiovascular diseases, several forms of cancer (such as breast, colon and prostate), pulmonary, osteoarticular and metabolic diseases in the past decades. Recently, the hypolipidemic and anti-obesity effects of green tea in animals and humans have slowly become a hot topic in nutritional and food science research. This review will up-date the information of the anti-obesity effects of green tea in human intervention and animal studies. During recent years, an increasing number of clinical trials have confirmed the beneficial effects of green tea on obesity. However, the optimal dose has not yet been established owing to the very different results from studies with a similar design, which may be caused by differences in the extent of obesity, dietary intake, physical activity intensity, the strength of subjects’ compliance to test instruction, the genetic background of populations, body composition and dietary habits. Therefore, further investigations on a larger scale and with longer periods of observation and tighter controls are needed to define optimal doses in subjects with varying degrees of metabolic risk factors and to determine differences in beneficial effects among diverse populations. Moreover, data from laboratory studies have shown that green tea has important roles in fat metabolism by reducing food intake, interrupting lipid emulsification and absorption, suppressing adipogenesis and lipid synthesis and increasing energy expenditure via thermogenesis, fat oxidation and fecal lipid excretion.