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

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.

Conditions

• Obesity & Overweight

Interventions

DIETARY_SUPPLEMENT

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 Participants with poor tolerability will be withdrawn from the study.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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• Nutris We Care About You S.L.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-19

Primary Completion

2027-10-29

Completion

2027-10-29

Countries

• Spain

Study Locations