Clinical trial NCT02921217: Effect of a Probiotic on Visceral Fat Accumulation
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
Overall status: UNKNOWN
Phase: PHASE3
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
Lead sponsor: Biopolis S.L.
Sponsor class: INDUSTRY
Collaborators: name: Technological Centre of Nutrition and Health
name: Hospital Universitari Sant Joan de Reus
name: University Rovira i Virgili
First posted: 2016-10-03
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change of abdominal visceral fat
timeFrame: Change from 0 weeks (V1) to 12 weeks (V3)
Secondary outcomes:
measure: Change of body weight
timeFrame: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
measure: Change of BMI
timeFrame: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
measure: Change of Waist circumference
timeFrame: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
measure: Change of Abdominal subcutaneous fat
timeFrame: Change from 0 weeks (V1) to 12 weeks (V3)
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Technological Centre of Nutrition and Health (CTNS)
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili / Hospital Universitari Sant Joan de Reus
name: Rosa Solà, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
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.