Screening Whole Grain Dietary Intake Biomarkers and Validating the Dose-response Relationship in a Randomized Controlled Study in China.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- whole grain plasma and urine biomarkers discovery and identification
研究概览
简要总结
Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains.
详细描述
An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour administered were 0 g, 25g, 50 g and 100 g. Experimental period with a total of 6 days was subdivided into two parts: -5 days to 0 h defined as the run-in period, 0-24 h (after the dose-related test meal), defined as the test day.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •age 18-40 years
- •BMI 18.5-23.9 kg/m2.
排除标准
- •pregnancy or breastfeeding
- •vegetarian;
- •acute and chronic diseases;
- •allergic to wheat;
- •frequent nutrients supplement use;
- •medication use of antibiotics within 1-month;
- •more than 3 kg weight change within 3-month;
- •unwillingness to follow dietary restrictions;
结局指标
主要结局
whole grain plasma and urine biomarkers discovery and identification
时间窗: Baseline and 0~24 hours after intervention food intake
Discovery of whole grain plasma and urine biomarkers after acute intakes of WG wheat food using LC-MS untargeted metabolomics approach in a designed study, identify the specific biomarkers for WG wheat with high confidence levels.
次要结局
- Validate the performance of the potential WG biomarkers.(Baseline and 0~24 hours after intervention food intake)