Effect of a Probiotic on Visceral Fat Accumulation (BIFFAT)

September 30, 2016 updated by: Biopolis S.L.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Recruiting
        • Technological Centre of Nutrition and Health (CTNS)
        • Sub-Investigator:
          • Ignasi Papell-Garcia, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ActivBPL1
Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)
Dietary supplement: Active Probiotic
Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
Experimental: InactivBPL1
Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)
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),
Placebo Comparator: Control
Dietary supplement: Control
Placebo: 300 mg maltodextrin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of abdominal visceral fat
Time Frame: 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).
Change from 0 weeks (V1) to 12 weeks (V3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body weight
Time Frame: 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)
Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of BMI
Time Frame: 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 from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of Waist circumference
Time Frame: 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 from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of Abdominal subcutaneous fat
Time Frame: 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 from 0 weeks (V1) to 12 weeks (V3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biopolis S.L.

Collaborators

University Rovira i Virgili
Hospital Universitari Sant Joan de Reus
Technological Centre of Nutrition and Health

Investigators

  • Principal Investigator: Rosa Solà, Prof. MD, University Rovira i Virgili / Hospital Universitari Sant Joan de Reus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIFFAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Active Probiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe