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

Sponsor
Nutris We Care About You S.L.
Study ID
NCT07758387
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Polydextrose Gummies — DIETARY_SUPPLEMENT
    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 to 2 gummies before each meal. From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal, 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 Participants with poor tolerability will be withdrawn from the study.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 to 30 minutes before meals, preferably with a glass of water. All participants will also receive standard dietary and physical activity recommendations.
  • Placebo Gummies — DIETARY_SUPPLEMENT
    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 to 2 gummies before each meal. From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal, 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 Participants with poor tolerability will be withdrawn from the study.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 to 30 minutes before meals, preferably with a glass of water. All participants will also receive standard dietary and physical activity recommendations.

Study Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Oct 19, 2026
Status verified
Aug 2026
Primary completion
Oct 29, 2027
Completion
Oct 29, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Polydextrose Gummies Group
    Participants will receive functional gummies containing polydextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.
  • Placebo Comparator: Placebo Gummies Group
    Participants will receive matching placebo gummies without polidextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.

Primary Outcome Measure

Body Weight [ Time Frame: Baseline and Week 24 ]

Central Contacts

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