Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090, Russia
NCT Number: NCT06221696
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
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Novosibirsk, Novosibisk Region, 630090, Russia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three daily packets of active fiber supplement (each containing 1g of glucomannan, 1g of inulin, and 3g of psyllium), taken 30 minutes before each main meal. The supplement is provided by S.Lab (Soloways), LLC.
Three daily packets of placebo powder, taken 30 minutes before each main meal.
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Monitoring the changes in Body Mass Index from the baseline
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
Time frame: 180 days
S.LAB (SOLOWAYS)
Other
Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
Acronym: PWR-FAST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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