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

Obesity Clinical Trial

— SOLFIBERGP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06188832
• Other study ID #: SW003
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: January 18, 2023

Study information

• Verified date: December 2023
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 18, 2023
• Est. primary completion date: November 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• glucomannan, inulin, and psyllium
the subjects recieved fiber supplement containing glucomannan, inulin, and psyllium

Other:
• placebo
the subjects recieved placebo

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (3)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies, Triangel Scientific

Country where clinical trial is conducted

Russian Federation, 

Outcome

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