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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
129
Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
Placebo: 300 mg maltodextrin.
Technological Centre of Nutrition and Health (CTNS)
Reus, Tarragona, Spain
RECRUITINGChange 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).
Time frame: Change from 0 weeks (V1) to 12 weeks (V3)
Change of body weight
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)
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)
Time frame: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of Waist circumference
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)
Change of Abdominal subcutaneous fat
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)
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