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临床试验/NCT02898571
NCT02898571Unknown不适用

Cross-over Double-blind Intervention to Investigate the Effects of Defined Antioxidant-containing Drinks on Time Course of Antioxidant Capacity

Newcastle University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Antioxidant capacity

研究概览

简要总结

The aim of this project is to measure the differences in antioxidant capacity at different time points after consuming a single dose of antioxidant-containing drink (vitamin C or epicatechin) compared with a control drink in 10 volunteers, and then match the data with the proposed modelling corresponding to either homeostasis or accumulation. Additionally it will also determine whether the effect on changes of antioxidant capacity in response to epicatechin and vitamin c is equal.

详细描述

The sample size is 10 volunteers. This was based on an estimate of the number of datasets required to ensure that at least some of the datasets show time courses that are suitable for the demonstration. The trial uses a cross-over double-blind placebo-controlled design.

A participant information sheet will be given to the participant to read at least 24 hours prior to the screening. Eligibility of participants will be checked during the screening session. The participant anthropometric measurements (height, weight, body fat) will be taken and a Health Questionnaire will be filled completed.

Inclusion Criteria: Healthy adults, BMI 18.5-30

Exclusion Criteria: Any disease or medication that affects metabolism or digestion, smokers, common cold or other inflammatory illness at the time of bio-sample collection. Any other physical or mental condition that in the judgement of the experimenter would mean that participation in the study would be an undue burden on the volunteer.

At the screening session, the participant will be informed the relevant details of the study. Specifically they must avoid consumption of fruits, vegetables and whole grain products, coffee and tea, beer and wine for 48 hours before the start of the intervention and 24 hours after it (however cola, 7-up and similar caffeine-containing drinks without any real fruits or herbs are fine). After they have had opportunity to ask any questions regarding the testing procedures, if they are happy to take part, they will be free to ask and sign a consent form.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adults,
  • •BMI 18.5-30

排除标准

  • •Any disease or medication that affects metabolism or digestion, smokers, common cold or other inflammatory illness at the time of bio-sample collection. Any other physical or mental condition that in the judgement of the experimenter would mean that participation in the study would be an undue burden on the volunteer

研究组 & 干预措施

Placebo

Placebo Comparator

360ml water based drink containing 50g mix of glucose and fructose plus flavouring

干预措施: Placebo (Dietary Supplement)

Vitamin C

Experimental

360ml water based drink containig 60mg vitamin C and 50g mix of glucose and fructose plus flavouring

干预措施: Vitamin C (Dietary Supplement)

Epicatechin

Experimental

360ml water based drink containig 80mg epicatechin and 50g mix of glucose and fructose plus flavouring

干预措施: epicatechin (Dietary Supplement)

结局指标

主要结局

Antioxidant capacity

时间窗: Baseline 0, 0.5, 1, 1.5, 2, 2.5, 3.5, 5, 6, 8 and 24 hours post dose

measure the differences in antioxidant capacity at different time point after consuming a single dose of antioxidant-containing drink (vitamin C or epicatechin) compared with a control and then match the data with the proposed modelling corresponding to either homoeostasis or accumulation.

次要结局

  • Antioxidant capacity of epicatechin and vitamin-C(Baseline 0, 0.5, 1, 1.5, 2, 2.5, 3.5, 5, 6, 8 and 24 hours post dose)

研究者

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

Anthony Watson

NU-Food Facility Manager

Newcastle University

研究点 (1)

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