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Effect of a Probiotic on Visceral Fat Accumulation (BIFFAT)

Primary Purpose

Obesity, Intra-Abdominal Fat, Subcutaneous Fat, Abdominal

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Active Probiotic
Inactivated probiotic
Control
Sponsored by
Biopolis S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Technological Centre of Nutrition and Health (CTNS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ActivBPL1

InactivBPL1

Control

Arm Description

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

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

Control

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change of body weight
Body weight measured with Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA)
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 of Waist circumference
Waist circumference, measured according to the criteria of Lohman et al. 1988.
Change of Abdominal subcutaneous fat
Abdominal subcutaneous fat measured by 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI).

Full Information

First Posted
July 20, 2016
Last Updated
September 30, 2016
Sponsor
Biopolis S.L.
Collaborators
Technological Centre of Nutrition and Health, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
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1. Study Identification

Unique Protocol Identification Number
NCT02921217
Brief Title
Effect of a Probiotic on Visceral Fat Accumulation
Acronym
BIFFAT
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biopolis S.L.
Collaborators
Technological Centre of Nutrition and Health, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Intra-Abdominal Fat, Subcutaneous Fat, Abdominal
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ActivBPL1
Arm Type
Experimental
Arm Description
Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)
Arm Title
InactivBPL1
Arm Type
Experimental
Arm Description
Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control
Intervention Type
Dietary Supplement
Intervention Name(s)
Active Probiotic
Intervention Description
Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
Intervention Type
Dietary Supplement
Intervention Name(s)
Inactivated probiotic
Intervention Description
Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Placebo: 300 mg maltodextrin.
Primary Outcome Measure Information:
Title
Change of abdominal visceral fat
Description
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).
Time Frame
Change from 0 weeks (V1) to 12 weeks (V3)
Secondary Outcome Measure Information:
Title
Change of body weight
Description
Body weight measured with Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA)
Time Frame
Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Title
Change of BMI
Description
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)
Time Frame
Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Title
Change of Waist circumference
Description
Waist circumference, measured according to the criteria of Lohman et al. 1988.
Time Frame
Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Title
Change of Abdominal subcutaneous fat
Description
Abdominal subcutaneous fat measured by 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI).
Time Frame
Change from 0 weeks (V1) to 12 weeks (V3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Maria Valls, PhD
Phone
+34 636 944 723
Email
estudis@ctns.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Pedret, PhD
Phone
+34 636 944 723
Email
estudis@ctns.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosa Solà, Prof. MD
Organizational Affiliation
University Rovira i Virgili / Hospital Universitari Sant Joan de Reus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technological Centre of Nutrition and Health (CTNS)
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Maria Valls, PhD
Phone
+34 636 944 723
Email
estudis@ctns.cat
First Name & Middle Initial & Last Name & Degree
Anna Pedret, PhD
First Name & Middle Initial & Last Name & Degree
Ignasi Papell-Garcia, BSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15562393
Citation
Vaccaro O, Masulli M, Cuomo V, Rivellese AA, Uusitupa M, Vessby B, Hermansen K, Tapsell L, Riccardi G. Comparative evaluation of simple indices of insulin resistance. Metabolism. 2004 Dec;53(12):1522-6. doi: 10.1016/j.metabol.2004.05.017.
Results Reference
background
Links:
URL
http://www.ctns.cat
Description
Technological Centre of Nutrition and Health

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Effect of a Probiotic on Visceral Fat Accumulation

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