Evaluation of Postprandial Effects of High Molecular Weight Polyphenols in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Postprandial insulin
研究概览
简要总结
The aim of this is study is to evaluate the effects of a single intake of a mixture of cacao and carob (rich in high molecular weight polyphenols) in postprandial metabolism in subjects with type 2 diabetes. Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used food extracts, ignoring high molecular weight polyphenols as relevant bioactive compounds. In this study, the potential of this kind of polyphenols for regulating postprandial disturbances in type 2 diabetes subjects, since these alterations increased the cardiovascular risk in these subjects, will be evaluated. The study has been designed in order to differentially evaluate the effect of intact polyphenols and that of microbial-derived phenolic metabolites.
详细描述
Twenty-five subjects with a recent diagnosis of type 2 diabetes will be recruited. Detailed inclusion and exclusion criteria are provided below.
The whole intervention has been divided in 3 treatments A, B and C, performed every 2 weeks in randomized order for each subject. In every treatment, subjects will attend to the Unit of Human Nutrition of the ICTAN-CSIC in fasting state and they will receive a high-sugar high-fat breakfast. Treatment A will be used as control and will only consist of breakfast. Treatment B is characterized by the administration of a mixture of cocoa and carob solved in milk together with breakfast. In treatment C, volunteers will consume the same amount of product 10 hours before attending to their visit, where the breakfast will be administrated once again. Food and drinks provided in the three visits (including milk used in treatment B) will be similar. The aim of treatment B is to elucidate the role of intact polyphenols, while treatment C will evaluate the effect of microbial-derived polyphenol metabolites.
Blood samples will be collected before breakfast and at times 60-120-180-240-270 min. Urine will be collected during their permanence at the Unit of Human nutrition of the ICTAN-CSIC. Feces will be collected as soon as they are generated after receiving treatments A and C. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, GLP-1, hepatic enzymes. Urine and feces will be used to evaluate phenolic metabolites. Additionally, a satiety test will be provided. It is expected that cocoa and carob supplementation, as compared to the control treatment, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the decrease in postprandial insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Since no placebo was found, the subjects will know the treatment they are receiving in each case. Nevertheless, the outcome assessor will not know to which treatment corresponds each sample.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes during the last 2 years and current treatment with metformin
- •Overweight or obesity (IMC = 26-40 kg/m2)
排除标准
- •Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- •Subjects with diagnoses of cardiovascular diseases or thyroid diseases.
- •Values above the following ones: glucose, > 125 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- •Previous bariatric surgery.
- •Volunteers currently participating in other studies or weight loss plans.
- •Pregnant or breastfeeding women.
- •Adherence to vegetarian diets or usual consumption of dietary supplements.
- •Intolerance or allergy to some of the foods provided in the study
结局指标
主要结局
Postprandial insulin
时间窗: Up to two months
Changes of postprandial insulin as result of supplementation with cocoa and carob
次要结局
- Postprandial glucose(Up to four months)
- Postprandial uric acid(Up to four months)
- Postprandial triglycerides(Up to four months)
- Postprandial phenolic metabolites(Up to six months)
- Postprandial GLP-1(Up to five months)
- Satiety measured by a Visual Analogue Scale (see "Description" for details)(Up to three months)
研究者
Jara Pérez-Jiménez
Principal Investigator
National Research Council, Spain