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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sclerocarya birrea | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement: nutraceutical | Dietary Supplement | Subjects will consume two capsules at breakfast and dinner for ten weeks. |
|
| 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 |
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Inclusion Criteria:
Age: 18-65 years.
Diagnosis of prediabetes according to the American Diabetes Association.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Murcia | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Subjects will consume two capsules at breakfast and dinner for ten weeks. |
|
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 |
| D004700 | Endocrine System Diseases |