Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms (SOLFIBERGP)

February 5, 2024 updated by: S.LAB (SOLOWAYS)
This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

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:

  • Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR).
  • Overweight or obese status (BMI ≥ 25).

Exclusion Criteria:

- BMI < 25

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fiber Supplementation
The active powder contained 1g glucomannan, 1g inulin, and 3g psyllium per bag.
Dietary supplement: glucomannan, inulin, and psyllium
the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium
Placebo Comparator: Placebo group
The placebo powder composed of maltodextrin and rice flour, carefully selected to mimic the texture and volume of the active powder without providing any active dietary fiber
Other: placebo
the subjects recieved placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body-weight change in %
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body-weight reduction ≥5%
Time Frame: 180 days
180 days
body-weight reduc-tion ≥10%
Time Frame: 180 days
180 days
Body weight in kg
Time Frame: 180 days
180 days
Body mass index change in %
Time Frame: 180 days
180 days
Fat mass change in %
Time Frame: 180 days
180 days
Systolic blood pressure in mmHg
Time Frame: 180 days
180 days
Fat-free mass change in kg
Time Frame: 180 days
180 days
Visceral fat rating change from baseline
Time Frame: 180 days
180 days
Diastolic blood pressure in mmHg
Time Frame: 180 days
180 days
Total cholesterol ratio
Time Frame: 180 days
180 days
LDL-C ratio
Time Frame: 180 days
180 days
HDL-C ratio
Time Frame: 180 days
180 days
Triglycerides ratio
Time Frame: 180 days
180 days
hsCRP ratio
Time Frame: 180 days
180 days
Fasting plasma glucose mmol/l
Time Frame: 180 days
180 days
Side effects %
Time Frame: 180 days
any side effects or adverse events reported by subjects
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)

March 2, 2022

Primary Completion (Actual)

November 19, 2022

Study Completion (Actual)

January 18, 2023

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW003

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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