Clinical trial NCT06221696: Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)
Official title: Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Semaglutide
Dietary Fiber
Weight Loss
Appetite Suppression
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
name: Triangel Scientific
First posted: 2024-01-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of weight regain from baseline
timeFrame: 180 days
Secondary outcomes:
measure: blood glucose levels change
timeFrame: 180 days
measure: blood HbA1c change
timeFrame: 180 days
measure: blood total cholesterol change
timeFrame: 180 days
measure: blood LDL change
timeFrame: 180 days
measure: blood triglycerides change
timeFrame: 180 days
measure: Systolic and diastolic blood pressure change
timeFrame: 180 days
measure: BMI changes
timeFrame: 180 days
measure: Visceral fat rating change from baseline
timeFrame: 180 days
measure: fat-free mass changes
timeFrame: 180 days
measure: visceral fat changes
timeFrame: 180 days
measure: total body water changes
timeFrame: 180 days
measure: 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
timeFrame: 180 days
Other outcomes:
measure: 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.
timeFrame: 180 days
measure: 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
timeFrame: 180 days
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References: