Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
129 participants
INTERVENTIONAL
2016-07-31
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ActivBPL1
Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)
Active Probiotic
Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
InactivBPL1
Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145)
Inactivated probiotic
Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
Control
Control
Control
Placebo: 300 mg maltodextrin.
Interventions
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Active Probiotic
Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
Inactivated probiotic
Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
Control
Placebo: 300 mg maltodextrin.
Eligibility Criteria
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Inclusion Criteria
* Waist circumference ≥102 cm (men) or ≥88 cm (women) and \<150cm
* Written informed consent provided before the initial screening visit.
* 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.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Technological Centre of Nutrition and Health
OTHER
Hospital Universitari Sant Joan de Reus
OTHER
University Rovira i Virgili
OTHER
Biopolis S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Rosa Solà, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
University Rovira i Virgili / Hospital Universitari Sant Joan de Reus
Locations
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Technological Centre of Nutrition and Health (CTNS)
Reus, Tarragona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Technological Centre of Nutrition and Health
Other Identifiers
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BIFFAT
Identifier Type: -
Identifier Source: org_study_id
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