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临床试验/NCT05837858
NCT05837858已完成不适用

Study on Biomarkers of Whole Grain Dietary Intake in Chinese Population

Peking University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.

研究概览

简要总结

The goal of this food intervention study is to screen/validate the whole grain food intake biomarker in health Chinese's population.

详细描述

Although increased consumption of whole grains (WGs) is associated with improved health outcomes, the dietary intake assessment and health mechanisms for WGs or WG-containing food remain unresolved. In addition, information regarding its consumption and health effects in Chinese people is scarce. Biomarkers of WGs intake would allow a more accurate assessment of its consumption in nutrition studies. The investigators want to perform a crossover study where participants were subjected to a WG-wheat flour or a refine wheat-flour Chinese diet. Using a metabolomics approach, the investigators aimed to identify the WG-specific metabolites present in plasma/urine after consumption WG or WG foods, including new candidate biomarkers of WG intake.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

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

Changes in metabolite profiles present in blood plasma and urine before the dietary intervention and in kinetics over 24 hours.

时间窗: Baseline and 0-24 hours after intervention food intake

Metabolite profiles analyzed using a non-targeted metabolomics approach and targeted metabolomics approach with a Orbitrap Mass Analyzer. Blood plasma samples collected at time 0 hours, 2 hours, 4 hours, and 24 hours. Urine fractions collected at 0-2 hours, 2-4 hours, 4-6 hours, 6-9 hours, 9-12 hours, 12-24 hours and 24-48 hours. Identification of biomarkers of acute intake of the foods of interest through the comparison of specific metabolomes after single dose of WG food or refined grain food in Chinese population.

次要结局

  • The influence of gut flora on whole grain markers(after the administration of the test meal)

研究者

发起方
Peking University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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