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

January 20, 2024 updated by: S.LAB (SOLOWAYS)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Novosibisk Region
      • Novosibirsk, Novosibisk Region, Russian Federation, 630090
        • Center of New Medical Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI ≥30, or ≥27 with comorbidities.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Other: placebo
Semaglutide (2.4 mg weekly). Three daily packets of placebo powder, taken 30 minutes before each main meal.
Experimental: Semaglutide with Active Fiber Supplement Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in body weight from baseline
Time Frame: 180 days
180 days
Achievement of a reduction in body weight of 5% or more from baseline.
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI change
Time Frame: 180 days
180 days
Safety evaluated by recording any adverse events.
Time Frame: 180 days
180 days
fat mass change
Time Frame: 180 day
fat mass change assessed using bioelectrical impedance analysis
180 day
fat-free mass change
Time Frame: 180 days
fat-free mass change assessed using bioelectrical impedance analysis
180 days
visceral fat rating change
Time Frame: 180 days
visceral fat rating change assessed using bioelectrical impedance analysis
180 days
total body water change
Time Frame: 180 days
total body water change assessed using bioelectrical impedance analysis
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.LAB (SOLOWAYS)

Collaborators

Center of New Medical Technologies
Triangel Scientific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

August 20, 2023

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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