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

S.LAB (SOLOWAYS)

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: glucomannan, inulin, and psyllium; Other: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06188832

SW003

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups, including a placebo group

Fiber Supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: glucomannan, inulin, and psyllium

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: placebo