Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Active Fiber Supplement Group; Other: Placebo Group

• Registration Number: NCT06221696
• Lead Sponsor: S.LAB (SOLOWAYS)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Primary Completion: 2023-11-23
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Adults with a history of obesity or overweight and completed Semaglutide course.
• Age 18-65 years.-

Exclusion Criteria

• Serious chronic illnesses.
• History of bulimia or anorexia.
• Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Fiber Supplement Group	Active Fiber Supplement Group	-
Placebo Group	Placebo Group	-

Primary Outcome Measures

Name	Time	Method
Percentage of weight regain from baseline	180 days

Secondary Outcome Measures

Name	Time	Method
Visceral fat rating change from baseline	180 days
blood LDL change	180 days
visceral fat changes	180 days
blood triglycerides change	180 days
BMI changes	180 days	Monitoring the changes in Body Mass Index from the baseline
blood glucose levels change	180 days
blood total cholesterol change	180 days
total body water changes	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	180 days
blood HbA1c change	180 days
Systolic and diastolic blood pressure change	180 days
fat-free mass changes	180 days

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation