Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity

Overweight and Obesity Clinical Trial

— ESSENCE  

Official title:

Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06215196
• Other study ID #: SW004
• Status: Completed
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: August 20, 2023

Study information

• Verified date: January 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: August 20, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI =30, or =27 with comorbidities.

Exclusion Criteria:

• Serious chronic illnesses.
• History of bulimia or anorexia.
• Pregnancy or lactation.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Fiber Supplement Group
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.

Other:
• placebo
Semaglutide (2.4 mg weekly). Three daily packets of placebo powder, taken 30 minutes before each main meal.

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (3)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies, Triangel Scientific

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in body weight from baseline		180 days
Primary	Achievement of a reduction in body weight of 5% or more from baseline.		180 days
Secondary	BMI change		180 days
Secondary	fat mass change	fat mass change assessed using bioelectrical impedance analysis	180 day
Secondary	Safety evaluated by recording any adverse events.		180 days
Secondary	fat-free mass change	fat-free mass change assessed using bioelectrical impedance analysis	180 days
Secondary	visceral fat rating change	visceral fat rating change assessed using bioelectrical impedance analysis	180 days
Secondary	total body water change	total body water change assessed using bioelectrical impedance analysis	180 days