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临床试验/NCT01912144
NCT01912144已完成不适用

Bioavailability of Coffee Phenolic Acids and Cardiovascular Health in Healthy Humans.

University of Leeds2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Quantitative absorption of chlorogenic acids metabolites

研究概览

简要总结

Phenolic acids are naturally-occurring constituents of plant-derived foods and beverages and are characterised by a phenol ring in their structure. The phenolic compounds we are going to focus on in this study are the Chlorogenic acids (CGAs), a family of esters conjugates formed between a Hydroxycinnamic acid and quinic acid (1) and that show a strong antioxidant activity (2).

HCAs represent about 50% of the total polyphenolic coumpounds intake in a typical UK diet (3) and for people who drink it, coffee is a/the major dietary source of/for HCAs (4). A few studies suggest protective effects for cardiovascular diseases (5), neurodegenerative diseases, type 2 diabetis and liver and kidneys cancer risk. However, many data in the field are obtained from in vitro and/or in animal, and it is difficult and dangerous to extrapolate between these and risk in humans of development or progression of particular health conditions, more human studies are therefore needed.

We aim to compare people that metabolise the best CGAs from coffee to those that metabolise them the least well. This will be achieved by measuring the metabolites in urine. The effect of CGAs on the human body does not only depend on the amount ingested, but also on the quality of the metabolism, we therefore also want to determine which mechanisms are responsible for inter-individual variations in order to identify any link with health biomarkers, these including non-cellular inflammation and cardiovascular risk indicators.

For this cohort study funded by the University of Leeds, approximately 60 healthy volunteers will be recruited at the School of Food Science & Nutrition. If they meet the selection criteria, participants will be asked to undergo a 36-hour wash-out period. During those 36 hours, participants won't be allowed to drink coffee, they will be asked to follow a diet low in phenolic acids and keep a record of their meals. On the first day of the study, a single dose of coffee rich in antioxidants will be given to the participant and urine will be collected from that time until 36 hours after coffee consumption. Participants will be followed again after 5 to 6 weeks.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-70 years
  • Normal Body Mass Index (BMI) 18-29 kg/m2
  • Non-smoker, former or weak smoker (max. 5 cigarettes per day)
  • No more than 4 alcoholic units as a regular and daily consumption

排除标准

  • diagnosed chronic disease (e.g. pancreas, kidneys, liver, heart)
  • haemophilia
  • long term prescribed medication (contraceptive medication allowed)
  • previous GI (gastrointestinal) tract operation
  • pregnant or breast feeding

研究组 & 干预措施

coffee

Other

Coffee beverage

干预措施: Coffee (Other)

结局指标

主要结局

Quantitative absorption of chlorogenic acids metabolites

时间窗: up to 7 months

Analysis using liquid chromatography with or without mass spectrometry, colorimetric and enzyme-linked immunosorbent assays.

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

Gary Williamson

Prof

University of Leeds

研究点 (2)

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