Effect of a Probiotic on Visceral Fat Accumulation (BIFFAT)

Biopolis

Status and phase: Unknown; Phase 3

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

Treatments: Dietary Supplement: Active Probiotic; Dietary Supplement: Inactivated probiotic; Dietary Supplement: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02921217

BIFFAT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 3 patient groups, including a placebo group

ActivBPL1

Experimental group

Description:

Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)

Treatment:

Dietary Supplement: Active Probiotic

InactivBPL1

Experimental group

Description:

Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)

Treatment:

Dietary Supplement: Inactivated probiotic

Control

Placebo Comparator group

Description:

Control

Treatment:

Dietary Supplement: Control