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

S.LAB (SOLOWAYS)

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: Placebo Group; Dietary Supplement: Active Fiber Supplement Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06221696

SW005

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

Active Fiber Supplement Group

Experimental group

Treatment:

Dietary Supplement: Active Fiber Supplement Group

Placebo Group

Placebo Comparator group

Treatment:

Other: Placebo Group