Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects (PRED)

Universidad Católica San Antonio de Murcia

Status

Completed

Conditions

PreDiabetes

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Dietary Supplement: nutraceutical

Study type

Interventional

Funder types

Other

Identifiers

NCT04132908

UCAMCFE-0006

Details and patient eligibility

About

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 will be measured analytically. Other secondary variables such as lipid profile, inflammatory markers, blood pressure, endothelial function and body composition will also be determined.

Enrollment

70 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.