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| Name | Class |
|---|---|
| Technological Centre of Nutrition and Health | OTHER |
| Hospital Universitari Sant Joan de Reus | OTHER |
| University Rovira i Virgili | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ActivBPL1 | Experimental | Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) |
|
| InactivBPL1 | Experimental | Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) |
|
| Control | Placebo Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Probiotic | Dietary Supplement | Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g), |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Maria Valls, PhD | Contact | +34 636 944 723 | estudis@ctns.cat | |
| Anna Pedret, PhD | Contact | +34 636 944 723 | estudis@ctns.cat |
| Name | Affiliation | Role |
|---|---|---|
| Rosa Solà , Prof. MD | University Rovira i Virgili / Hospital Universitari Sant Joan de Reus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technological Centre of Nutrition and Health (CTNS) | Recruiting | Reus | Tarragona | 43204 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15562393 | Background | 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. |
| Label | URL |
|---|---|
| Technological Centre of Nutrition and Health | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002318 | Cardiovascular Diseases |
| D001835 | Body Weight |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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), |
|
| Control | Dietary Supplement | Placebo: 300 mg maltodextrin. |
|
| 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. | 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). | Change from 0 weeks (V1) to 12 weeks (V3) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D010335 | Pathologic Processes |