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临床试验/NCT07391696
NCT07391696进行中(未招募)不适用

Coffee Intake Biomarker Validation and Association With Respiratory Diseases

National University of Singapore1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Urinary and serum metabolite changes associated with coffee consumption

研究概览

简要总结

This proposed project aims to identify and validate biomarkers of coffee exposure in the Singapore population, and assess the association between coffee consumption (via biomarker measurements) and risk of respiratory diseases in a prospective multi-ethnic cohort in Singapore.

Specific Aim 1: To identify and quantify urinary/serum metabolite changes that are associated with coffee consumption in a dose-response intervention study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Regular coffee drinkers aged 21-64 years old, Chinese ethnicity

排除标准

  • Healthy individuals who are regular coffee and/or tea drinkers, aged 21-64 years old of Chinese ethnicity with no severe medical conditions and are physically-abled, can participate in the research. However, you cannot participate in or will be released from this study if the following conditions or situations apply to you:
  • Ineligible screening survey which will consist of basic demographic information and questions pertaining to inclusion/exclusion criteria such as age, gender, current medications, chronic illness, etc
  • Dislike drinking coffee and tea
  • Pregnant or breastfeeding
  • Certain medications including Zanaflex, Sirasalud, Ketanest S, Spravato and Ephedrine Sulfate (See full list of medication)
  • Present medical conditions: cancer, cardiometabolic diseases, endocrine diseases, depression, anxiety, caffeine/lactose intolerant, fear of needles and/or blood disorders
  • Recent history of major surgical operations
  • Past or current user of oral/systemic hormone treatment or therapies
  • Taken antibiotics in the last 3 months
  • Taking nutritional supplements (that contains coffee/tea-related compounds naturally found in other plants)
  • Not willing to travel to the University for the study
  • Unable to commit to completing all the sessions in the 10-week intervention study

研究组 & 干预措施

Coffee Dose-Response Intervention

Experimental

Participants receive sequential dietary interventions with Coffee A, Coffee B/C, and Tea A across 12 weeks, interspersed with washout periods. Biological samples and dietary records are collected throughout.

干预措施: Coffee A (Dietary Supplement)

Coffee Dose-Response Intervention

Experimental

Participants receive sequential dietary interventions with Coffee A, Coffee B/C, and Tea A across 12 weeks, interspersed with washout periods. Biological samples and dietary records are collected throughout.

干预措施: Coffee B (Dietary Supplement)

Coffee Dose-Response Intervention

Experimental

Participants receive sequential dietary interventions with Coffee A, Coffee B/C, and Tea A across 12 weeks, interspersed with washout periods. Biological samples and dietary records are collected throughout.

干预措施: Tea (Dietary Supplement)

结局指标

主要结局

Urinary and serum metabolite changes associated with coffee consumption

时间窗: 12week

Urine and serum samples will undergo a combination of targeted and untargeted metabolomic profiling at the Singapore Phenome Centre located at NTU. Briefly, thawed urine, serum, coffee and tea samples will be analysed directly on the UHPLC-TQ-MS. Secondly, to explore potentially novel biomarkers and/or metabolites related to the consumption of the two types of coffee relevant to Singapore (black coffee and coffee with additives), untargeted metabolomics will be conducted on the urine and serum samples.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seow Wei Jie

Assistant Professor

National University of Singapore

研究点 (1)

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