Effect of a Probiotic on Visceral Fat Accumulation

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Obesity, Intra-Abdominal Fat, Subcutaneous Fat, Abdominal

Intervention / Treatment
-----------------
* Dietary Supplement: Active Probiotic
* Dietary Supplement: Inactivated probiotic
* Dietary Supplement: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults men or women (>18 years old) Waist circumference ≥102 cm (men) or ≥88 cm (women) and <150cm Written informed consent provided before the initial screening visit. Exclusion Criteria: Use of antibiotics within 30-days period before the study Waist circumference other than those specified in inclusion criteria Body mass index (BMI) ≥ 40 kg/m2 Glucose (fasting state) ≥ 126 mg/dL Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women) Suffer from claustrophobia (to the extent that precludes NMR). Wear pacemakers, electrical stimulators or cochlear implants (NMR contraindications) Following a hypocaloric diet and/or receiving pharmacologic treatment for weight loss Having eating disorders. Use of medication, antioxidant, or multi-vitamin supplements interfering with the study Chronic gastrointestinal pathology Being intolerant or suffer from allergy to any of the products of the study. Pregnant or intending to become pregnant Being in breastfeeding period. Chronic alcoholism Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study. Failing to follow study guidelines.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ActivBPL1<br>Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) | Dietary Supplement: Active Probiotic<br>* Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),<br>|
| Experimental: InactivBPL1<br>Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) | Dietary Supplement: Inactivated probiotic<br>* Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),<br>|
| Placebo Comparator: Control<br>Control | Dietary Supplement: Control<br>* Placebo: 300 mg maltodextrin.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of abdominal visceral fat | abdominal visceral fat will be measured by Nuclear Magnetic Resonance (NMR). The study will be conducted in 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI). | Change from 0 weeks (V1) to 12 weeks (V3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body weight | Body weight measured with Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA) | Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3) | 
| Change of BMI | Calculated using weight and height. Body weight measured with Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA). Height, measured by Tanita portable altimeter; BMI calculated (kg/m2) | Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3) | 
| Change of Waist circumference | Waist circumference, measured according to the criteria of Lohman et al. 1988. | Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3) | 
| Change of Abdominal subcutaneous fat | Abdominal subcutaneous fat measured by 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI). | Change from 0 weeks (V1) to 12 weeks (V3) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular diseases, abdominal visceral fat, subcutaneous body fat, body weight, waist circumference, lipid profile, insulin resistance, glucose metabolism, blood pressure, inflammation, adiponectin, leptin, metabolomics, cardiovascular risk factor