Fiber gummies: a tasty new weapon against obesity?
NCT ID NCT07758387
First seen Aug 11, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This trial tests whether gummies containing polydextrose, a type of dietary fiber, can help adults with overweight or obesity lose weight. Participants will take the gummies before meals for 24 weeks, alongside standard diet and exercise advice. The study compares weight loss, appetite, and safety against a placebo to see if this simple supplement could support weight management.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Polydextrose gummies (a dietary fiber supplement)
- What this could lead to
- If effective, polydextrose gummies could offer a simple, non-drug aid for weight management in people with overweight or obesity.
- What could go wrong
- This is a small, early-stage trial, and the effect on weight loss may be modest. Gastrointestinal discomfort is possible, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 glycated hemoglobin (HbA1c) greater than 7%, type 1 diabetes, or type 2 diabetes treated with multiple daily insulin injections. * Treatment with sodium-glucose co-transporter-2 (SGLT2) inhibitors for diabetes, heart failure, or chronic kidney disease. * Uncontrolled thyroid disease \[thyroid-stimulating hormone (TSH) outside the normal range\] 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 drugs, GLP-1 receptor agonists, chronic corticosteroids, antipsychotics, or fiber supplements). * Pregnancy or breastfeeding. * Women of childbearing potential who are trying to become pregnant or plan to become pregnant during the study. * Known allergy or intolerance to any ingredient of the study gummies. * History of severe gastrointestinal problems with fermentable fibers.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805, Spain
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