Effect of a Probiotic on Visceral Fat Accumulation — BIFFAT  

Obesity Clinical Trial

Official title: Randomized, Parallel, Double Blinded, Placebo-controlled Study for the Evaluation of the Effectiveness on Visceral Fat Accumulation in Individuals With Abdominal Obesity of a Specific Probiotic Compound

Status Recruiting

Clinical Trial Summary

The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.

Clinical Trial Description

The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.

Participants: 129 men and women with a waist circumference ≥102 cm (men) or ≥88 cm (women), randomly assigned to one of 3 treatment groups in parallel: one group (43 members) with active probiotic, another one with the probiotic inactivated by heat, and the last group with the placebo.

Treatment consists of product consumption study for 12 weeks, taking 1 capsule per day. 4 visits during the study, a pre-inclusion visit and 3 study visits (weeks 1, 6, and 12) will be scheduled.

Secondary objectives are to asses the probiotic's effects on:

• the accumulation of subcutaneous body fat and body weight, body mass index (BMI) and waist circumference.

• glucose metabolism and insulin resistance.

• blood lipid profile.

• blood pressure.

• inflammation.

• circulating levels of adiponectin and leptin.

• changes in the intestinal microbiome

The statistical analysis will follow the principles specified in the guidelines of the ICHE9 and CPMP/EWP/908/99 ICHE9 Points to Consider on Multiplicity Issues in Clinical Trials. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intra-Abdominal Fat
• Obesity
• Subcutaneous Fat, Abdominal

• NCT number: NCT02921217
• Study type: Interventional
• Source: Biopolis S.L.
• Contact: Rosa Maria Valls, PhD
• Phone: +34 636 944 723
• Email: estudis@ctns.cat
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2016
• Completion date: August 2017