Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects
NCT ID: NCT04132908
Last Updated: 2019-12-13
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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COMPLETED
NA
70 participants
INTERVENTIONAL
2016-10-01
2019-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sclerocarya birrea
Dietary Supplement: nutraceutical
Subjects will consume two capsules at breakfast and dinner for ten weeks.
Placebo
Placebo
Subjects will consume two capsules at breakfast and dinner for ten weeks.
Interventions
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Dietary Supplement: nutraceutical
Subjects will consume two capsules at breakfast and dinner for ten weeks.
Placebo
Subjects will consume two capsules at breakfast and dinner for ten weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of prediabetes according to the American Diabetes Association.
* Altered fasting glucose (95-125 mg / dl).
* Glucose intolerance (oral glucose tolerance test with glycemia at 2 hours between 140 - 199 mg / dl).
* Hemoglobin glycated between 5.7 and 6.4%.
* Subjects with body mass index between 18-35 Kg / m2.
* Stable food habits: there is no gain or weight loss of more than 5 kg in the ten weeks.
* I do not consume foods rich in Screrocaria Birrea.
Exclusion Criteria
* Use of medications that may interfere with glucose metabolism.
* Consumption of alcohol greater than 20 g / day.
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Participation in another clinical trial in the three months prior to the study
* Lack of will or inability to comply with clinical trial procedures.
* Pregnancy.
18 Years
75 Years
ALL
Yes
Sponsors
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Universidad Católica San Antonio de Murcia
OTHER
Responsible Party
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Francisco Javier López Román
Principal Investigator
Locations
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Catholic University of Murcia
Murcia, , Spain
Countries
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Other Identifiers
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UCAMCFE-0006
Identifier Type: -
Identifier Source: org_study_id