PreDiabetes
Conditions
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 will be measured analytically. Other secondary variables such as lipid profile, inflammatory markers, blood pressure, endothelial function and body composition will also be determined.
Interventions
DIETARY_SUPPLEMENTDietary Supplement: nutraceutical
Subjects will consume two capsules at breakfast and dinner for ten weeks.
DIETARY_SUPPLEMENTPlacebo
Subjects will consume two capsules at breakfast and dinner for ten weeks.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endothelial function | 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 | Changes in the dilatation of the Humeral artery. |
| blood samples | 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 | Changes in glycemic profile |
| Physical activity test | 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 | Change in physical activity with the World Physical Activity Questionnaire (GPAQ) |
| nutritional record | 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 | Potential changes in the dietary survey were controlled with a food diary |
| body composition | 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 | Changes in body composition were measured with a TANITA |
| glucose tolerance test | 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) . | Venous blood samples are taken from the finger at different times. |
Countries
Spain
Outcome results
None listed