NCT02921217

Effect of a Probiotic on Visceral Fat Accumulation

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (estimated)
• Sponsor: Biopolis S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active Probiotic	Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
DIETARY_SUPPLEMENT	Inactivated probiotic	Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
DIETARY_SUPPLEMENT	Control	Placebo: 300 mg maltodextrin.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-01
• Completion: 2017-08-01
• First posted: 2016-10-03
• Last updated: 2016-10-03

Locations

1 site across 1 country: Spain