Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity

Not Applicable

Completed

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

• Registration Number: NCT06215196
• Lead Sponsor: S.LAB (SOLOWAYS)

Brief Summary

This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-14
• Primary Completion: 2023-06-28
• Study Completion: 2023-08-20
• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-20
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• BMI ≥30, or ≥27 with comorbidities.

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
Semaglutide with Active Fiber Supplement Group	Fiber Supplement Group	-
Placebo group	placebo	-

Primary Outcome Measures

Name	Time	Method
Achievement of a reduction in body weight of 5% or more from baseline.	180 days
Percentage change in body weight from baseline	180 days

Secondary Outcome Measures

Name	Time	Method
visceral fat rating change	180 days	visceral fat rating change assessed using bioelectrical impedance analysis
BMI change	180 days
fat mass change	180 day	fat mass change assessed using bioelectrical impedance analysis
fat-free mass change	180 days	fat-free mass change assessed using bioelectrical impedance analysis
Safety evaluated by recording any adverse events.	180 days
total body water change	180 days	total body water change assessed using bioelectrical impedance analysis

Trial Locations

Locations (1)

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