Health Effects of Grain Foods in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Glycemia
研究概览
简要总结
This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium.
详细描述
This 16-week, randomized, controlled, parallel-arm, clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics, appetite, food/energy intake, body weight, and blood pressure as well as acute and longer-term glycemia and lipemia. It will also examine the effects of foods varying in grain/carbohydrate composition on the microbiome and microbiota functionality. One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups. These groups will be defined by the diets they are prescribed. All will be prescribed diets containing approximately 50%; 35% and 15% energy from carbohydrate, fat and protein, respectively. Grain foods will comprise 50% of the carbohydrate component (i.e., 25% of total energy). The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars. The grain foods meeting these criteria will have the following composition:
Group 1 - High Whole Grain, Low Sugar 6 servings of whole grain and <13% energy from added sugars.
Group 2 - Low Whole Grain, Low Sugar 3 servings of whole grain and <13% energy from added sugars.
Group 3 - High Whole Grain, High Sugar 6 servings of whole grain and >13% energy from added sugars.
Group 4 - Low Whole Grain, High Sugar 3 servings of whole grain and >13% energy from added sugars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female; 21 to 60 years old; Hemoglobin A1c concentration between 5.7 and 6.4%
- •Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same dose for the duration of the trial.
- •low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy).
排除标准
- •Grain or dairy sensitivities or allergies or celiac disease; sensitivity or allergy to other foods that would result in refusal to eat a class of foods.
- •intended weight loss or gain during the study period; intended change of activity level during the study period
- •use of blood thinners
- •prior gastrointestinal surgery.
结局指标
主要结局
Glycemia
时间窗: 12 weeks
blood sugar
次要结局
- Appetite(12 weeks)
- Taste Hedonics(12 weeks)
- Energy Intake(12 weeks)
- Lipemia(12 weeks)
- Systolic and Diastolic Blood Pressure(12 weeks)
- Body Weight(12 weeks)
研究者
Richard Mattes
Distinguished Professor
Purdue University