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

NCT ID: NCT06188832

Last Updated: 2025-03-27

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

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2023-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Fiber Supplementation

The active powder contained 1g glucomannan, 1g inulin, and 3g psyllium per bag.

Group Type EXPERIMENTAL

glucomannan, inulin, and psyllium

Intervention Type DIETARY_SUPPLEMENT

the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

the subjects recieved placebo

Interventions

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glucomannan, inulin, and psyllium

the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium

Intervention Type DIETARY_SUPPLEMENT

placebo

the subjects recieved placebo

Intervention Type OTHER

Eligibility Criteria

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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
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

References

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Pokushalov E, Ponomarenko A, Garcia C, Pak I, Shrainer E, Seryakova M, Johnson M, Miller R. The Impact of Glucomannan, Inulin, and Psyllium Supplementation (SolowaysTM) on Weight Loss in Adults with FTO, LEP, LEPR, and MC4R Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024 Feb 17;16(4):557. doi: 10.3390/nu16040557.

Reference Type RESULT
PMID: 38398881 (View on PubMed)

Related Links

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Other Identifiers

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SW003

Identifier Type: -

Identifier Source: org_study_id

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