Effect of a Probiotic on Visceral Fat Accumulation

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02921217
• Other study ID #: BIFFAT
• Status: Recruiting
• Phase: Phase 3
• First received: July 20, 2016
• Last updated: September 30, 2016
• Start date: July 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2016
• Source: Biopolis S.L.
• Contact: Rosa Maria Valls, PhD
• Phone: +34 636 944 723
• Email: estudis[@]ctns.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intra-Abdominal Fat
• Obesity
• Subcutaneous Fat, Abdominal

Intervention

Dietary Supplement:
• Active Probiotic
Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
• Inactivated probiotic
Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
• Control
Placebo: 300 mg maltodextrin.

Locations

Country	Name	City	State
Spain	Technological Centre of Nutrition and Health (CTNS)	Reus	Tarragona

Sponsors (4)

Lead Sponsor	Collaborator
Biopolis S.L.	Hospital Universitari Sant Joan de Reus, Technological Centre of Nutrition and Health, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   Technological Centre of Nutrition and Health