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Completed

NCT Number: NCT06188832

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glucomannan, inulin, and psyllium

Dietary Supplement

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

Placebo

Other

the subjects recieved placebo

Primary outcomes

  1. Body-weight change in %

    Time frame: 180 days

Secondary outcomes

  1. body-weight reduction ≥5%

    Time frame: 180 days

  2. body-weight reduc-tion ≥10%

    Time frame: 180 days

  3. Body weight in kg

    Time frame: 180 days

  4. Body mass index change in %

    Time frame: 180 days

  5. Fat mass change in %

    Time frame: 180 days

  6. Systolic blood pressure in mmHg

    Time frame: 180 days

  7. Fat-free mass change in kg

    Time frame: 180 days

  8. Visceral fat rating change from baseline

    Time frame: 180 days

  9. Diastolic blood pressure in mmHg

    Time frame: 180 days

  10. Total cholesterol ratio

    Time frame: 180 days

  11. LDL-C ratio

    Time frame: 180 days

  12. HDL-C ratio

    Time frame: 180 days

  13. Triglycerides ratio

    Time frame: 180 days

  14. hsCRP ratio

    Time frame: 180 days

  15. Fasting plasma glucose mmol/l

    Time frame: 180 days

  16. Side effects %

    Time frame: 180 days

    any side effects or adverse events reported by subjects

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies
  • Triangel Scientific

Registry information

Acronym: SOLFIBERGP

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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