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

Universidad Católica San Antonio de Murcia70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

PreDiabetes

Interventions

Dietary Supplement: nutraceuticalDIETARY_SUPPLEMENT

Subjects will consume two capsules at breakfast and dinner for ten weeks.

PlaceboDIETARY_SUPPLEMENT

Subjects will consume two capsules at breakfast and dinner for ten weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Catholic University of Murcia

Murcia, Spain

Outcomes

Primary Outcomes

endothelial function

Changes in the dilatation of the Humeral artery.

Time frame: The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after ten weeks of product consumption. Up to 10 weeks

blood samples

Changes in glycemic profile

Time frame: It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks

Physical activity test

Change in physical activity with the World Physical Activity Questionnaire (GPAQ)

Time frame: Quality of life measurements are taken with physical activity test on two different occasions. The measurements are made at the beginning and after ten weeks of consumption of the product. Up to 10 weeks

nutritional record

Potential changes in the dietary survey were controlled with a food diary

Time frame: The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks

body composition

Changes in body composition were measured with a TANITA

Time frame: Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks

glucose tolerance test

Venous blood samples are taken from the finger at different times.

Time frame: The glucose measurements in venous blood are taken with a glucometer on three different occasions (1: at baseline before consumption of the product, 2: at five weeks and 3: ten weeks after ingestion of the layer product observe the changes) .

Data from ClinicalTrials.gov

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