Effectiveness of Pasta and Other Starchy Foods With a Low Glycemic Response to Promote Cardio-metabolic and Emotional Well-being.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- The effects of Low-GI and Hi-GI diets
研究概览
简要总结
the aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.
详细描述
The overall aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a low glycemic response (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a high glycemic response (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• BMI 25-37 kg/m2 with a waist circumference > 102 cm (males) or > 88 cm (females) and one additional feature of Metabolic Syndrome according to ATPIII [1], including blood pressure > 130/85 or treatment, fasting plasma glucose >100mg/dL, fasting triglycerides >150 mg/dL, HDL cholesterol < 40 mg/dL (males) or 50 mg/dL (females),
- •weight stable (± 3 kg in previous 3 mo);
- •no acute illness; and non-diabetic.
排除标准
- •age <30 and >69years;
- •fasting triglycerides ≥400 mg/dL;
- •fasting cholesterol >240 mg/dL or low-density lipoprotein cholesterol>160 mg/dL
- •fasting glucose >126 mg/dL,
- •systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg
- •a BMI >37 kg/m2, weight changes during the previous 3 months (greater than ± 3 kg),
- •stable intensive physical activity regimen during the previous 3 months (>3 h/wk of moderate or high intensity exercise, resistance or aerobic training).
- •cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;
- •renal and liver failure (creatinine >1.7 mg/dl and ALT/AST >2 times than normal values, respectively);
- •anaemia (Hb <12 g/dL);
- •diabetes mellitus.
- •If you are pregnant
结局指标
主要结局
The effects of Low-GI and Hi-GI diets
时间窗: 15weeks
All subjects will consume the same quantities of metabolizable carbohydrate (270 g/d) with 135 g of carbohydrates assigned to the GI intervention foods. The 135 g of carbohydrates will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Fiber is set as 35 g/d for both intervention groups. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be \<55 (Low-GI group) or \>70 (Hi-GI group).
次要结局
- Insulin Sensitivity(15 weeks)
研究者
Wayne Campbell
Principal Investigator
Purdue University