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

NCT ID: NCT06221696

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2023-12-01

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

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Fiber Supplement Group

Group Type: EXPERIMENTAL

Active Fiber Supplement Group

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo Group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Group

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center of New Medical Technologies

OTHER

Sponsor Role: collaborator

Triangel Scientific

INDUSTRY

Sponsor Role: collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia

Countries

Russia

Other Identifiers

SW005

Identifier Type: -

Identifier Source: org_study_id