Effect of a Probiotic on Visceral Fat Accumulation (NCT02921217) | Clinical Trial Compass
UnknownPhase 3
Effect of a Probiotic on Visceral Fat Accumulation
Spain129 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Change of abdominal visceral fat
Timeframe: Change from 0 weeks (V1) to 12 weeks (V3)