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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: glucomannan, inulin, and psyllium; Other: placebo

• Registration Number: NCT06188832
• Lead Sponsor: S.LAB (SOLOWAYS)

Brief Summary

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

Not available

Study Timeline

• Study Start: 2022-03-02
• Primary Completion: 2022-11-19
• Study Completion: 2023-01-18
• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

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

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Exclusion Criteria

• BMI < 25

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiber Supplementation	glucomannan, inulin, and psyllium	The active powder contained 1g glucomannan, 1g inulin, and 3g psyllium per bag.
Placebo group	placebo	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

Primary Outcome Measures

Name	Time	Method
Body-weight change in %	180 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation