Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity
ESSENCE
1 other identifier
interventional
81
1 country
1
Brief Summary
This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2023
CompletedFirst Submitted
Initial submission to the registry
January 10, 2024
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedJanuary 23, 2024
January 1, 2024
3 months
January 10, 2024
January 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage change in body weight from baseline
180 days
Achievement of a reduction in body weight of 5% or more from baseline.
180 days
Secondary Outcomes (6)
BMI change
180 days
fat mass change
180 day
Safety evaluated by recording any adverse events.
180 days
fat-free mass change
180 days
visceral fat rating change
180 days
- +1 more secondary outcomes
Study Arms (2)
Semaglutide with Active Fiber Supplement Group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORInterventions
Semaglutide (2.4 mg weekly). 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.
Semaglutide (2.4 mg weekly). Three daily packets of placebo powder, taken 30 minutes before each main meal.
Eligibility Criteria
You may qualify if:
- BMI ≥30, or ≥27 with comorbidities.
You may not qualify if:
- Serious chronic illnesses.
- History of bulimia or anorexia.
- Pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- S.LAB (SOLOWAYS)lead
- Center of New Medical Technologiescollaborator
- Triangel Scientificcollaborator
Study Sites (1)
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2024
First Posted
January 22, 2024
Study Start
April 14, 2023
Primary Completion
June 28, 2023
Study Completion
August 20, 2023
Last Updated
January 23, 2024
Record last verified: 2024-01