NCT06221696Completed
Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)
Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 Feb 2024
Brief summary (registry, in English)
This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 15 Jan 2024
- Start date
- 12 Jun 2023
- Primary completion date
- 23 Nov 2023
- Lead sponsor
- S.LAB (SOLOWAYS)
- Diseases
- Obesity
- NCT number
- NCT06221696
What you commit to
- Study type: Interventional
- Participants enrolled: 160
- From 12 Jun 2023 to the primary completion date, 23 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Serious chronic illnesses.
- History of bulimia or anorexia.
Other
- Pregnancy or lactation.
Who the study is looking for
- Adults with a history of obesity or overweight and completed Semaglutide course.
- Age 18-65 years.-
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center of New Medical Technologies Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.