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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical-nutritional Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on the Glycemic Profile in Prediabetic Subjects

Conditions
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PreDiabetes

Intervention / Treatment
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* Dietary Supplement: Dietary Supplement: nutraceutical
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sclerocarya birrea<br> | Dietary Supplement: Dietary Supplement: nutraceutical<br>* Subjects will consume two capsules at breakfast and dinner for ten weeks.<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Subjects will consume two capsules at breakfast and dinner for ten weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function | Changes in the dilatation of the Humeral artery. | 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 | 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) | 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 | 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 | 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. | 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) . | 
| blood samples | Changes in lipidic profile:( total cholesterol, HDL and LDL) , it will be measured in mg/dl. | 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 |