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

NCT ID: NCT06215196

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-14

Study Completion Date

2023-08-20

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Semaglutide with Active Fiber Supplement Group

Group Type EXPERIMENTAL

Fiber Supplement Group

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI ≥30, or ≥27 with comorbidities.

Exclusion Criteria

* Serious chronic illnesses.
* History of bulimia or anorexia.
* Pregnancy or lactation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center of New Medical Technologies

OTHER

Sponsor Role collaborator

Triangel Scientific

INDUSTRY

Sponsor Role collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia

Site Status

Countries

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Russia

Other Identifiers

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SW004

Identifier Type: -

Identifier Source: org_study_id

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