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Polydextrose Functional Gummies for Weight Management in Adults With Overweight or Obesity
Sponsor: Nutris We Care About You S.L.
Summary
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 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 main objective is to determine whether polydextrose gummies produce a greater percentage reduction in body weight than placebo after 24 weeks. 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 consumption of polydextrose functional gummies for 24 weeks will result in greater weight loss than placebo and may improve subjective feelings of appetite and satiety in adults with overweight or obesity.
Official title: Randomized Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Functional Gummies With Polydextrose Versus Placebo for Weight Control in Adults With Overweight or Obesity
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2026-10-19
Completion Date
2027-10-29
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
Polidextrose Gummies
Participants in the experimental group will consume the polydextrose gummies before each main meal (breakfast, lunch, and dinner) for 24 weeks. The daily dose will be gradually increased during the first week from 1 gummy before each meal (approximately 13.5 g of polydextrose per day) to 2 gummies before each meal (approximately 27 g/day). From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal (approximately 40.5 g/day), while those with acceptable tolerability will remain at 2 gummies before each meal. Participants with poor tolerability will be withdrawn from the study. The gummies will be taken approximately 15-30 minutes before meals, preferably with a glass of water.
Placebo Gummies
Participants in the control group will consume matching placebo gummies without polydextrose before each main meal (breakfast, lunch, and dinner) for 24 weeks. The daily dose will be gradually increased during the first week from 1 gummy before each meal (approximately 6 g of maltitol per day) to 2 gummies before each meal (approximately 12 g/day). From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal (approximately 18 g/day), while those with acceptable tolerability will remain at 2 gummies before each meal. Participants with poor tolerability will be withdrawn from the study. The gummies will be taken approximately 15-30 minutes before meals, preferably with a glass of water. All participants will also receive standard dietary and physical activity recommendations.
Locations (1)
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain