Effect of Whole Grain Diet on Insulin Sensitivity, Advanced Glycation End Products and Inflammatory Markers in Pre-diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Homeostatic model assessment(HOMA) index
研究概览
简要总结
Food products derived from cereal grains constitute a major part of the daily diet of many Americans . For example, a typical Chinese American eats rice about 9.5 times a week on an average. However, most of these foods are derived from refined grain. During the refining process grains are stripped of their bran and germ which results in depletion of several biologically active constituents including fiber, anti-oxidants, phytoestrogens and minerals. From observational studies there is evidence for a protective effect of whole-grain foods with regard to the development of type 2 diabetes. More recently, higher intake of whole grains was also associated with decreases in insulin resistance - a risk factor related to the development of type 2 diabetes.
In this randomized study the investigators plan to replicate this beneficial effect of improving insulin sensitivity in patients with pre-diabetes and go a step further by exploring the potential mechanisms by which this benefit may occur. The investigators will assess the effect of consuming a whole-grain-rich diet on levels of advanced glycation endproducts (AGE), RAGE (receptor for AGE) and markers of inflammation and oxidative stress - all of which have been shown to play an important role in the pathogenesis of diabetes mellitus. The investigators will also look for correlations between the levels of these markers with insulin sensitivity to identify potential mechanisms of pathogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years to unlimited, both genders.
- •At least one meal per day included rice in the seven days prior to enrolment.
- •No current diagnosis of Diabetes Mellitus (DM).
- •Fasting blood glucose value between 100 to 125 mg/dl and/or Hemoglobin A1c levels between 5.7%-6.4%.
- •≥ 2 visits with primary care physician to establish compliance
排除标准
- •Special diets (e.g. vegetarian)
- •Use of medications that would affect blood sugar levels (e.g. steroids)
- •Allergy to any type of grain
- •Body weight fluctuation over the past 180 days of ≥ 10%
- •Planning to significantly change level of physical activity during the time of study.
- •Planning to move out of town or take a vacation for ≥ 14 days during the time of the study
- •Current smoker
- •Consumption of greater than 2 alcoholic drinks per day
- •History of malignancy and overt cardiovascular disease (apart from hypertension).
结局指标
主要结局
Homeostatic model assessment(HOMA) index
时间窗: 6 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic Model Assessment (HOMA) Index
时间窗: 0
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
Homeostatic model assessment (HOMA) index.
时间窗: 12 weeks
Estimates insulin resistance and β-cell function from fasting glucose and insulin levels
次要结局
- IL-6(0, 6 and 12 weeks)
- Sirtuin 1(0, 6 and 12 weeks)
- Methylglyoxal (MG)(0, 6 and 12 weeks)
- Receptor for advanced glycation endproducts (RAGE)(0, 6 and 12 weeks)
- Carboxymethyl lysine (CML)(0, 6 and 12 weeks)