Status:
COMPLETED
Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects
Lead Sponsor:
Universidad Católica San Antonio de Murcia
Conditions:
PreDiabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
It consists in the intake, during a period of 10 weeks, of a nutraceutical (natural extract of Sclerocarya birrea). It is a clinical trial, during which certain parameters of the glucidic metabolism w...
Eligibility Criteria
Inclusion
- Age: 18-65 years.
- 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
- Subjects with a history of any type of liver or kidney pathology.
- 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.
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04132908
Start Date
October 1 2016
End Date
January 4 2019
Last Update
December 13 2019
Active Locations (1)
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1
Catholic University of Murcia
Murcia, Spain, 30107