Clinical-nutritional Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on the Glycemic Profile in Prediabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- endothelial function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 / m
- •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.
排除标准
- •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.
结局指标
主要结局
endothelial function
时间窗: 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.
nutritional record
时间窗: 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
时间窗: 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
Physical activity test
时间窗: 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)
glucose tolerance test
时间窗: 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.
blood samples
时间窗: 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
次要结局
未报告次要终点
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia