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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
160
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.
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, Russia
Percentage of weight regain from baseline
Time frame: 180 days
blood glucose levels change
Time frame: 180 days
blood HbA1c change
Time frame: 180 days
blood total cholesterol change
Time frame: 180 days
blood LDL change
Time frame: 180 days
blood triglycerides change
Time frame: 180 days
Systolic and diastolic blood pressure change
Time frame: 180 days
BMI changes
Monitoring the changes in Body Mass Index from the baseline
Time frame: 180 days
Visceral fat rating change from baseline
Time frame: 180 days
fat-free mass changes
Time frame: 180 days
visceral fat changes
Time frame: 180 days
total body water changes
Time frame: 180 days
Effect of glucomannan, inulin, and psyllium on appetite assessed using mean postprandial participant-reported visual analog score (VAS) ratings from 0 to 10 points, where 0 is appetite absence and 10 good appetite, following a standardized breakfast
Time frame: 180 days
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