Last updated on February 2018

Effect of a Probiotic on Visceral Fat Accumulation


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02921217

Contact Investigators or Research Sites near you

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Rosa Maria Valls, PhD

Technological Centre of Nutrition and Health (CTNS)
Reus, Spain
2.08miles
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Recruitment Status: Open


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