Hunger Buddy must be taken as a whole capsule with a full glass of water (approximately 250ml). Do not open the capsule and avoid taking it in powder form to avoid choking. Our study has several limitations. One limitation is that it was performed over a short period of only 12 weeks, with no follow-up conducted after the study was finished and no weight maintenance phase after the initial weight loss. As such, the study provides no information about the effects of IQP-AE-103 on long-term weight maintenance and on other obesity-related conditions such as diabetes or cardiovascular disease. In addition, the study included subjects of a wide age range. Although the distribution of different age groups was not substantially different between groups in the current study, it may be helpful to include age as a stratification factor in future study. Changes in gut microbiota composition occur with age [ 52], and it has been shown that altered gut microbiota may be associated with obesity [ 53], since IQP-AE-103 contains fibres and polysaccharides from okra pod and inulin, it is likely that the composition of the intestinal gut microbiota may be positively influenced by the consumption of IQP-AE-103. Hence, analysis of gut microbiota changes in overweight and obese subjects of different age groups may provide additional knowledge regarding the effect of IQP-AE-103. Moreover, appetite sensations in the study were assessed using VAS and rating scales, which were not validated for the specific use to measure changes in a similar study design. Last but not least, self-reporting of dietary intake by study subjects, applied for reasons of practicality, may be a limitation. It is known that factors such as gender and weight status affect subjects’ behavior in reporting energy intake; for example, females tended to underreport compared with males, and increasing weight status was associated with an increase in underreporting of energy intake [ 54]. As such, results obtained in the current study, primarily evaluating weight loss, on IQP-AE-103’s effect on appetite sensations remain exploratory. To evaluate a potential effect of IQP-AE-103 on food/energy intake, quantification of actual calorie intake by recording food consumption at an “ad libitum” lunch may be considered in future studies. Plants have always been a good source of new potential and natural therapies for illnesses, including body weight management products. Litramine®, a natural fibre complex derived from Opuntia ficus-indica, enriched with soluble fibres from Acacia sp., has been shown in a number of clinical trials to safely and effectively reduce and maintain weight loss [ 17– 20]. Litramine® has been demonstrated to reduce dietary fat absorption and increase fecal fat excretion, resulting in lower calorie absorption from diet, which leads to weight loss [ 20, 21]. The study evaluated the effectiveness and tolerability of Redusure (IQP-AK-102), a patent-pending fibre complex and key ingredient in bmiSMART's I-CONTROL appetite reducer, for promoting weight loss in overweight and obese individuals. Results found that subjects who received Redusure saw significantly higher weight reduction than those who received the placebo.

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.For all statistical analyses, the level of significance ( ) was assumed. Efficacy and safety data were analyzed based on full analysis set (FAS) population, which was defined as subjects who have received at least one dose of the investigational product and had a baseline and at least one postbaseline assessment. All statistical analyses were done using the SPSS statistic software, V22.0 (SPSS, Chicago, IL). All other efficacy as well as the safety and concurrent variables were exploratively examined and were descriptively assessed. For the metric data (continuous data), the statistical characteristics were given (number, mean, standard deviation, median, extremes, quartiles, and 95% confidence interval of mean). For ordinal data (discrete data), frequency distribution was performed. All nominal data (categorical data) were summarized using frequency tables. All variables were evaluated primarily by exact nonparametric procedures: (i) Kruskal–Wallis test for more than two independent groups (comparison of groups or subgroups) (ii) Mann–Whitney U test for independent groups (comparison of groups or subgroups) (iii) Wilcoxon test for dependent groups (comparison of pre-post within groups or subgroups) (iv) Fisher’s exact test for comparison of percentage.

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. B. Grube, et al., “A Natural Fiber Complex Reduces Body Weight in the Overweight and Obese: A Double-Blind, Randomized, Placebo-Controlled Study,” Obesity 21, 58–64 (2013). Proprietary ingredient clinically shown to increase satiety and support significant weight loss in overweight and obese adults As demonstrated by Zaluvida Group’s research and evidenced in InQpharm’s three bmiSMART products, efficacious, safe and easy to apply approaches to weight management do exist. They also allow adaption to individual dietary habits (such as preference for fatty foods or carbohydrate-rich diets) and can help to overcome initial hunger sensations while individuals are transitioning to a healthier diet. 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.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. 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 IQP-AE-103 demonstrated a very good tolerability profile in our study as expected since okra is typically consumed as food and inulin is widely consumed as fibre/prebiotic supplements. Additionally, okra has shown no toxicity in animals at doses up to 4000 mg/kg [ 50]. A safety review on inulin by Carabin and Flamm [ 51] has found no treatment-related toxic effects nor carcinogenicity or genotoxicity. In our study, the overall tolerability towards the IQP-AE-103 in high and low doses was comparable to that in the placebo, according to the rating by the subjects and the investigator. Observed adverse events were unrelated with the IQP-AE-103 consumption. Moreover, there were no significant differences in stool frequency. Therefore, in contrast to many available anti-obesity products that cause unpleasant and sometimes serious side effects, IQP-AE-103 could be considered as a safe, well-tolerated, and effective weight management agent.

Dietetic and pharmaceutical preparations for the treatment of metabolic syndrome and related diseases namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia and obesity, general weight management, treatment of obesity and prevention of obesity; chemical preparations for medical and pharmaceutical purposes for the treatment of metabolic syndrome and related diseases for the treatment of metabolic syndrome and related diseases namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia and obesity, general weight management, treatment of obesity and prevention of obesity; dietary supplement for humans for general health and wellbeing; pharmaceutical and nutraceutical preparations primarily of plant extracts adapted for dietetic use for the treatment and prevention of metabolic syndrome and related diseases, namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia, anemia, bulimia nervosa, anorexia and obesity, general weight management, treatment of obesity and prevention of obesity; pharmaceutical and nutraceutical preparations primarily of plant extracts adapted for medical use for the treatment and prevention of metabolic syndrome and related diseases, namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia, anemia, bulimia nervosa, anorexia and obesity, general weight management, treatment of obesity and prevention of obesity; pharmaceutical and nutraceutical preparations primarily of plant extracts adapted for nutritional use for the treatment and prevention of metabolic syndrome and related diseases, namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia, anemia, bulimia nervosa, anorexia and obesity, general weight management, treatment of obesity and prevention of obesity; pharmaceutical and nutraceutical preparations primarily of plant extracts adapted for pharmaceutical use for the treatment and prevention of metabolic syndrome and related diseases, namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia, anemia, bulimia nervosa, anorexia and obesity, general weight management, treatment of obesity and prevention of obesity; plant extracts adapted for the treatment of metabolic syndrome and related diseases for the treatment and prevention of metabolic syndrome and related diseases, namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia, anemia, bulimia nervosa, anorexia and obesity, general weight management, treatment of obesity and prevention of obesity, general weight management, treatment of obesity, prevention of obesity and blood glucose management; medicated food supplements for the treatment of metabolic syndrome and related diseases, namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia, anemia, bulimia nervosa, anorexia and obesity, general weight management, treatment of obesity and prevention of obesity, general weight management, treatment of obesity and prevention of obesity; weight management supplements; nutritional food additives for medical purposes in the nature of food extracts derived from plant extracts, for the treatment of metabolic syndrome and related diseases, namely, diabetes, hypoglycaemia, hypertension, heart diseases, cardiovascular diseases, hyperlipidaemia, hypercholesterolemia, anemia, bulimia nervosa, anorexia and obesity, general weight management, treatment of obesity and prevention of obesity; plant extracts for medical use namely extract of Amorphophallus konjac; nutritional supplements to reduce, control appetite; nutritional sup

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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.

Don't take this product if you are allergic to sulphur-containing products (such as sulfites) or any of the ingredients listed. If you experience any allergic symptoms, such as skin rashes or difficulty in breathing or any other side effects, please consult your doctor immediately. 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. The REDUSURE trademark was assigned an Application Number # 1756268 by the Canadian Intellectual Property Office (CIPO). Current solutions include Litramine, which was awarded the first Class II medical device certification for a plant-based weight management product in the world, and Tanitol, the first enzyme inhibitor that achieved medical device certification by targeting multiple digestive enzymes.

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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. At the end of the study, significant reductions in mean BMI were seen in both high-dose (1.75 ± 0.83 kg/m 2, ) and low-dose (1.09 ± 0.75 kg/m 2, ) IQP-AE-103 subjects in comparison to the placebo group (0.34 ± 0.77 kg/m 2). Direct comparisons of IQP-AE-103 with other weight loss agents that affect dietary fat absorption such as chitosan, Litramine®, or orlistat are difficult for methodological reasons. Ho et al. reported that there were no significant changes from baseline in body weight after 12 weeks of treatment with chitosan [ 39]. A treatment with Litramine® (a proprietary fibre complex) led to 3.8 kg weight loss after 12 weeks of intake [ 17]. As for orlistat (gastric and pancreatic lipase inhibitor), a study by Anderson et al. reported a 3.05 kg weight loss in overweight subjects after 16 weeks of treatment at 180 mg per day [ 40], whereas at higher dose of 360 mg per day, it caused a body weight reduction of 8.3 kg after 12-week period in obese women [ 41].