Polydextrose Functional Gummies for Weight Management in Adults With Overweight or Obesity

Overweight and obesity are common conditions that increase the risk of metabolic and cardiovascular diseases. Polydextrose is a type of dietary fiber that may help increase feelings of fullness by influencing natural hormones involved in appetite regulation. It may also improve postprandial glycemic responses and modulate the gut microbiota. However, evidence for its effectiveness in weight management remains limited. The purpose of this study is to evaluate the efficacy and safety of functional gummies containing polydextrose compared with placebo for weight management in adults with overweight or obesity. Participants will be randomly assigned to receive either polydextrose or placebo gummies for 24 weeks, together with standardized dietary and physical activity recommendations. The primary objective is to compare the percentage change in body weight over 24 weeks between participants receiving polydextrose gummies and those receiving placebo. The study will also evaluate appetite and satiety, body composition, waist circumference, metabolic parameters, quality of life, gastrointestinal symptoms, and the safety and tolerability of the study product. The study hypothesis is that daily intake of polydextrose gummies for 24 weeks will lead to a greater reduction in body weight than placebo and may improve subjective feelings of appetite and satiety in adults with overweight or obesity.

NCT Number	NCT07758387
Lead Sponsor	Nutris We Care About You S.L.
Conditions	Obesity & Overweight
Enrollment	96 participants
Start Date	2026-10-19
Primary Completion	2027-10-29 (estimated)
Study Completion	2027-10-29 (estimated)
Updated on ClinicalTrials.gov	2026-08-14