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

Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

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 Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Dietary supplement: Active Fiber Supplement Group; Other: Placebo Group

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibisk Region
    • Novosibirsk, Novosibisk Region, Russian Federation, 630090
      • Center of New Medical Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Other: Placebo Group; Three daily packets of placebo powder, taken 30 minutes before each main meal.
Experimental: Active Fiber Supplement Group	Dietary supplement: Active Fiber Supplement Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of weight regain from baseline	180 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Fasting and mean postprandial changes in visual analog score (VAS) ratings from 0 to 10 points for thirst, nausea, and well-being following a standardized breakfast.	180 days
Participant-reported control of eating evaluated using the Control of Eating Questionnaire (CoEQ) with 20 questions containing 5 oprions where 1 means the best and 5 the worst outcome	180 days

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center of New Medical Technologies; Triangel Scientific

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): November 23, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Semaglutide; Weight Loss; Dietary Fiber; Appetite Suppression
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: SW005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No