Binge-eating disorder Obesity
Conditions
Interventions
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial with a duration of ninety days. Participants will be randomly allocated in a one-to-one ratio using a computer-gen
Sponsors
Gap Laboratório de Biotecnologia e Bioinformática Limitada
Sm Empreendimentos Farmacêuticos Limitada (Nome Fantasia: Florien Fitoativos)
Eligibility
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Men and women; aged between 20 and 45 years; body mass index between 27 and 35 kilograms per square meter; non-smokers; engaging in moderate physical activity between 1 and 5 hours per week; provision of written informed consent
Exclusion criteria
Exclusion criteria: Allergy to any component of the supplement; severe gastrointestinal, endocrine, or metabolic diseases; chronic use of medications or ergogenic supplements; pregnant or breastfeeding women; adherence to a restrictive hypocaloric diet at the time of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An improvement in body composition is expected assessed by bioelectrical impedance analysis and demonstrated by a reduction in body mass index and body fat percentage together with an increase or maintenance of lean body mass with data collected before the start of the intervention and after ninety days of supplementation;Modulation of the intestinal microbiota is expected determined by the analysis of microbial diversity and the relative abundance of Akkermansia muciniphila with data collected before the start of the intervention and after ninety days of supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in fasting blood glucose serum insulin and the homeostatic model assessment of insulin resistance index is expected assessed by laboratory tests at baseline at thirty days at sixty days and at the end of the ninety-day intervention period;A reduction in total cholesterol low-density lipoprotein cholesterol and triglycerides together with an increase in high-density lipoprotein cholesterol is expected assessed by laboratory tests at baseline at thirty days at sixty days and at the end of the ninety-day intervention period;Favorable changes are expected in the serum levels of leptin adiponectin glucagon-like peptide-1 and ghrelin assessed by laboratory tests at baseline at thirty days at sixty days and at the end of the ninety-day intervention period;A reduction in inflammatory and intestinal barrier integrity markers including high-sensitivity C-reactive protein zonulin and fecal calprotectin is expected assessed by laboratory tests at baseline at thirty days at sixty days and at the end of the ninety-day intervention period;An increase in basal metabolic rate is expected measured by indirect calorimetry at baseline at thirty days at sixty days and at the end of the ninety-day intervention period;The safety and tolerability of supplementation are expected to be demonstrated through the systematic recording of adverse events throughout the ninety-day intervention period | — |
Countries
BR
Contacts
Public ContactJosé Roberto da Silva
Gap Laboratório de Biotecnologia e Bioinformática Limitada
Outcome results
None listed