Skip to main content
OpenTrials
Completed

NCT Number: NCT06221696

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Fiber Supplement Group

Dietary Supplement

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.

Placebo Group

Other

Three daily packets of placebo powder, taken 30 minutes before each main meal.

Primary outcomes

  1. Percentage of weight regain from baseline

    Time frame: 180 days

Secondary outcomes

  1. blood glucose levels change

    Time frame: 180 days

  2. blood HbA1c change

    Time frame: 180 days

  3. blood total cholesterol change

    Time frame: 180 days

  4. blood LDL change

    Time frame: 180 days

  5. blood triglycerides change

    Time frame: 180 days

  6. Systolic and diastolic blood pressure change

    Time frame: 180 days

  7. BMI changes

    Time frame: 180 days

    Monitoring the changes in Body Mass Index from the baseline

  8. Visceral fat rating change from baseline

    Time frame: 180 days

  9. fat-free mass changes

    Time frame: 180 days

  10. visceral fat changes

    Time frame: 180 days

  11. total body water changes

    Time frame: 180 days

  12. 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

Other outcomes

  1. 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.

    Time frame: 180 days

  2. 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

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies
  • Triangel Scientific

Registry information

Official study title

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

Acronym: PWR-FAST

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.