Effect of a Probiotic on Visceral Fat Accumulation

NCT02921217 | Unknown Phase 3

• 1 other identifier: BIFFAT
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Change of body weight

  Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)

• Change of BMI

  Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)

• Change of Waist circumference

  Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)

• Change of Abdominal subcutaneous fat

  Change from 0 weeks (V1) to 12 weeks (V3)

Study Arms (3)

ActivBPL1

EXPERIMENTAL

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

Dietary Supplement: Active Probiotic

InactivBPL1

EXPERIMENTAL

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

Dietary Supplement: Inactivated probiotic

Control

PLACEBO COMPARATOR

Control

Dietary Supplement: Control

Interventions

Active Probiotic DIETARY_SUPPLEMENT

Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),

ActivBPL1

Inactivated probiotic DIETARY_SUPPLEMENT

Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),

InactivBPL1

Control DIETARY_SUPPLEMENT

Placebo: 300 mg maltodextrin.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Use of antibiotics within 30-days period before the study
• 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
• Failing to follow study guidelines.

Sponsors & Collaborators

• Biopolis S.L.: lead
• Technological Centre of Nutrition and Health: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator
• University Rovira i Virgili: collaborator

Study Sites (1)

Technological Centre of Nutrition and Health (CTNS)

Reus, Tarragona, 43204, Spain

RECRUITING

Related 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. doi: 10.1016/j.metabol.2004.05.017.

  PMID: 15562393 BACKGROUND

Related Links

• Technological Centre of Nutrition and Health

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases; Body Weight; Insulin Resistance; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Study Officials

• Rosa Solà, Prof. MD

  University Rovira i Virgili / Hospital Universitari Sant Joan de Reus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosa Maria Valls, PhD

CONTACT

+34 636 944 723; estudis@ctns.cat

Anna Pedret, PhD

CONTACT

+34 636 944 723; estudis@ctns.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: October 3, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 3, 2016

Record last verified: 2016-09

Locations

ES (1)