Polydextrose Functional Gummies for Weight Management in Adults With Overweight or Obesity (NCT07758387) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Polydextrose Functional Gummies for Weight Management in Adults With Overweight or Obesity
Spain96 participantsStarted 2026-10-19
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 70 years.
* Body mass index (BMI) between 25 and 39.9 kg/m² (overweight or obesity class I-II).
* Stable body weight (no change greater than 3%) in the 3 months before joining the study.
* Usually eat at least 2 meals per day.
* Able and willing to follow the study procedures for 24 weeks, attend all scheduled visits, and complete the required records.
* Willing and able to sign the informed consent form.
Exclusion Criteria:
* Type 2 diabetes with HbA1c greater than 7%, type 1 diabetes, or type 2 diabetes treated with multiple daily insulin injections.
* Treatment with SGLT2 inhibitors for diabetes, heart failure, or chronic kidney disease.
* Uncontrolled thyroid disease (TSH outside the normal range) or recent changes in thyroid medication in the last 3 months.
* Significant gastrointestinal disease (such as severe irritable bowel syndrome, Crohn's disease, or ulcerative colitis).
* History of bariatric surgery.
* Liver cirrhosis.
* Advanced chronic kidney disease (stage IV-V).
* Following a very low-calorie diet (less than 800 kcal/day).
* Alcohol dependence or heavy alcohol use that, in the investigator's opinion, could affect the study.
* Current or recent eating disorder.
* Planning to start or recently started a specific weight-loss diet different from the one recommended by the study endocrinology service.
* Currently taking or having taken in the last 3 months medicines that affect appetite or body weight (such as anorectic d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Change in Body Weight From Baseline to Week 24