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

Overweight and Obesity Clinical Trial

— PWR-FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06221696
• Other study ID #: SW005
• Status: Completed
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 1, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.

Other:
• Placebo Group
Three daily packets of placebo powder, taken 30 minutes before each main meal.

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (3)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies, Triangel Scientific

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Percentage of weight regain from baseline		180 days
Secondary	blood glucose levels change		180 days
Secondary	blood HbA1c change		180 days
Secondary	blood total cholesterol change		180 days
Secondary	blood LDL change		180 days
Secondary	blood triglycerides change		180 days
Secondary	Systolic and diastolic blood pressure change		180 days
Secondary	BMI changes	Monitoring the changes in Body Mass Index from the baseline	180 days
Secondary	Visceral fat rating change from baseline		180 days
Secondary	fat-free mass changes		180 days
Secondary	visceral fat changes		180 days
Secondary	total body water changes		180 days
Secondary	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