World Health Organization, “Declaration of Helsinki,” Bulletin of the World Health Organization, vol. 86, no. 8, pp. 577–656, 2008.View at: Google Scholar As an intellectual property attorney, I understand how important it is to have high quality legal representation for protecting valuable brand names. Subjects underwent a 2-week run-in phase to assess the compliance to the study requirements and the recommended dietary regimen, before randomization for the 12-week treatment phase. Subjects were randomly allocated to either IQP-AE-103 high dose, IQP-AE-103 low dose, or the placebo group according to the randomization code provided by an independent statistician. Subjects were instructed to take two capsules of the investigational product three times daily, 15 minutes after each main meal (breakfast, lunch, and dinner), with a glass of water (250 ml). Each capsule of IQP-AE-103 high dose contained 330 mg dehydrated okra powder and 85 mg inulin, whereas low-dose capsules contained half the amount of okra powder and inulin; and placebo capsules contained standard excipients. All the capsules were identical in size and appearance. Dehydrated okra powder was obtained from whole okra pods ( Abelmoschus esculentus) that were cleaned, sliced, oven-dried at 60°C, and milled to form a fine powder. Inulin was extracted from freshly sliced chicory roots using hot water, followed by filtration and purification by discoloration and decalcification. The materials were tested for microbiological activity and contaminants, and inulin was tested for purity. The daily dosage of IQP-AE-103 was determined based on data obtained from a previous animal study that has shown efficacy in preventing weight gain and in increasing fecal excretion (data not shown). Considering the mode of action of the product, that is, reducing dietary fat absorption, the daily dosage was divided into 3 equal doses to be consumed after 3 main meals. In our study, BMI, body fat mass, and waist and hip circumference were also found to be decreased significantly in both IQP-AE-103 dose groups. Lowering waist circumference, a marker of abdominal fat content, indicates that the treatment with IQP-AE-103 could potentially lower the risk of diabetes, coronary heart disease, and nonalcoholic fatty liver disease [ 42– 44]. Additionally, the changes in fat-free mass were not significantly different between the treatment groups, indicating that the weight loss effect was primarily due to body fat reduction. Do not take Hunger Buddy during pregnancy or whilst breastfeeding, or if your BMI (Body Mass Index) is below 18.5. It is recommended that you calculate your BMI before and during use.

There were statistically significant differences in reduction of body fat mass between the study groups at the end of the study (IQP-AE-103 high dose, vs. placebo; low dose, vs. placebo and high dose vs. low dose, ). Reduction of fat-free mass was observed over time in all the three study groups; however, there were no significant differences between the study groups.

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The animal and in vitro data used to support the findings of this study are currently under embargo, whereas the research findings are commercialized. Data requests will be considered by the corresponding author 12 months after publication of this article. Conflicts of Interest The primary endpoint of this study was the comparison of the mean body weight (kg) change between IQP-AE-103 high dose and placebo after 12 weeks of intervention from baseline, in overweight and moderately obese subjects. The evaluation of the efficacy of IQP-AE-103 was based on the null hypothesis that there are no statistical differences between IQP-AE-103 and placebo in mean reduction of body weight after 12 weeks of treatment. The nonparametric Mann–Whitney U test for independent samples was applied. The testing was carried out by the determination of the rank sum of individual body weight changes.

Active Ingredient: Each capsule contains: Redusure™, a proprietary blend of high-swelling capacity dietary fibres. For beneficial action of fibres on gastrointestinal transit, it is recommended to drink at least 2L of water a day. Slight constipation could occur in case of limited liquid intake. If constipation persists despite adequate fluid intake, please consult your healthcare professional.

File size reduction is available for PDF documents only. If you provide a file in another format, we convert it to PDF automatically and then compress it. Responder rate for subjects who lost ≥3% and ≥5% of initial body weight at v6. LD = low dose; HD = high dose. a vs. placebo; b vs. placebo; c vs. low-dose group. There are three ways to upload your file: drag & drop, browse your hard drive or upload a PDF file from the cloud.Unfortunately, although obesity stems from consuming more calories than the body burns, more than 80% of overweight and obese individuals have trouble losing and maintaining weight loss through diet and exercise alone. These individuals recognise the serious health consequences of being overweight and often undertake drastic measures, including drug therapies and invasive surgeries, to achieve a healthier weight. Non-invasive weight management solutions Hunger Buddy does not contain any ingredient of animal origin and has no added artificial, flavourings, salt or preservatives. bmiSMART is the first weight management brand to introduce oral weight management treatments from InQpharm, a Zaluvida Group, which are based on continuous biotech innovations and research.

Another finding of this study is that besides weight loss, IQP-AE-103 showed beneficial effects on lipid metabolism. A significantly higher proportion of subjects in the high-dose IQP-AE-103 group experienced a reduction in triglyceride levels at the end of the study compared with placebo. In subjects with higher baseline total cholesterol levels (>6.2 mmol/L), high dose of IQP-AE-103 was shown to significantly reduce total cholesterol and LDL-cholesterol (pre-post change). Therefore, current outcome suggests that long-term treatment with IQP-AE-103 could be beneficial for subjects with elevated blood lipid levels in reducing the risk of cardiovascular disease. Each bmiSMART product complex has been tested for safety and efficacy, including placebo-controlled, randomised human clinical trials published in peer-reviewed, indexed journals. 3 A spectrum of weight management solutions U. Bongartz, et al., “Double-blind, Randomized, Placebo-Controlled, Bicentric Clinical Investigation to Evaluate the Benefit and Tolerability of Redusure IQP-AK-102 in Reducing Body Weight in Overweight and Obese Subjects,” Advancement in Medicinal Plant Research 4(3), 73–82 (2016). At the end of the study, 97.1% of the subjects in the high-dose IQP-AE-103 group and 85.3% in the low-dose group rated the benefits of the treatment as “good” or “very good” compared with 10% in the placebo group. However, investigator rated the benefit as “good” or “very good” for 94.1% and 85.3% of the subjects in high- and low-dose IQP-AE-103 groups, respectively, compared with 6.7% for placebo subjects. Once you did so, you can choose a preset to change and adjust the quality of your PDF file. You can choose between "basic" and "strong" compression, and using a preset.In addition, a combination of dehydrated okra pod powder and inulin, the active ingredients in IQP-AE-103, has been shown to be a strong fat-binding agent in an in vitro setting simulating in vivo conditions (data not shown); it also exerts high swelling capacity and significantly enhances solution viscosity. Thus, IQP-AE-103 appears to be a promising natural agent that may help to control calorie intake, decrease absorption of dietary fat, and consequently lead to body weight reduction. Institute of Medicine, Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), The National Acadamy Press, Washington, DC, USA, 2005. Figure 2: Litramine 14-week placebo-controlled, randomised, double-blind clinical trial results Weight loss through digestive enzyme inhibition Safety evaluation included measurement of laboratory parameters (full blood count, clinical chemistry, liver and renal functions and fat-soluble vitamins (A, D, E, and K) levels) and urine analysis at visit 1 and visit 6, as well as assessment of vital signs during each visit. Adverse events were recorded, regardless of causality at every visit. Global evaluation of tolerability by subjects and investigators was performed at the end of the study.