NCT06188832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

December 7, 2023

Last Update Submit

March 24, 2025

Conditions

Obesity

Keywords

obesitysupplementsbody mass indexoverweight

Outcome Measures

Primary Outcomes (1)

  • Body-weight change in %

    180 days

Secondary Outcomes (16)

  • body-weight reduction ≥5%

    180 days

  • body-weight reduc-tion ≥10%

    180 days

  • Body weight in kg

    180 days

  • Body mass index change in %

    180 days

  • Fat mass change in %

    180 days

  • +11 more secondary outcomes

Study Arms (2)

Fiber Supplementation

EXPERIMENTAL

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

Dietary Supplement: glucomannan, inulin, and psyllium

Placebo group

PLACEBO COMPARATOR

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

Interventions

glucomannan, inulin, and psylliumDIETARY_SUPPLEMENT

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

Fiber Supplementation
placeboOTHER

the subjects recieved placebo

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- BMI \< 25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

Related Publications (1)

  • 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.

    PMID: 38398881RESULT

Related Links

MeSH Terms

Conditions

ObesityOverweight

Interventions

(1-6)-alpha-glucomannanInulinPsyllium

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharidesPlant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

January 3, 2024

Study Start

March 2, 2022

Primary Completion

November 19, 2022

Study Completion

January 18, 2023

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

RU(1)