Effect of a Probiotic on Visceral Fat Accumulation

Phase 3

• Conditions: Intra-Abdominal Fat; Subcutaneous Fat, Abdominal; Obesity
• Interventions: Dietary Supplement: Active Probiotic; Dietary Supplement: Control; Dietary Supplement: Inactivated probiotic

• Registration Number: NCT02921217
• Lead Sponsor: Biopolis S.L.

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-20
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-30
• Last Update Submitted: 2016-09-30
• Study First Posted: 2016-10-03
• Last Update Posted: 2016-10-03
• Primary Completion: 2017-05
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ActivBPL1	Active Probiotic	Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)
Control	Control	Control
InactivBPL1	Inactivated probiotic	Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)

Primary Outcome Measures

Name	Time	Method
Change of abdominal visceral fat	Change from 0 weeks (V1) to 12 weeks (V3)	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).

Secondary Outcome Measures

Name	Time	Method
Change of Waist circumference	Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)	Waist circumference, measured according to the criteria of Lohman et al. 1988.
Change of BMI	Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)	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 of Abdominal subcutaneous fat	Change from 0 weeks (V1) to 12 weeks (V3)	Abdominal subcutaneous fat measured by 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI).
Change of body weight	Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)	Body weight measured with Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA)

Trial Locations

Locations (1)

Technological Centre of Nutrition and Health (CTNS); 🇪🇸 Reus, Tarragona, Spain