Coffee, Exercise, and Oxidative Stress
Coffee and Oxidative Stress During Exercise in Healthy Humans
研究概览
详细说明
Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. However, even if chlorogenic acids are known to be antioxidants in the cup, reliable evidence remains to be observed in vivo.
After medical examination and approval, subjects will undergo 2 periods of 21 days. The first 7 days will consist of a dietary restriction to lower the polyphenols intake. Then subjects will drink at random one of the three treatments for 14 days (4 cups/day). Blood and urine samples will be collected throughout the study to evaluate in vivo effects on oxidative biomarkers. Furthermore, at day 21, subjects will undergo a physical regimen to increase acutely and transiently their oxidative damage. Blood and urine samples collected throughout this challenge will allow us to evaluate the effect of coffee intake in reducing oxidative damage created by exercise compared to placebo.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Lausanne、瑞士、1000
- Clinical Development Unit / Metabolic Unit
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy
- Normal and overweight subjects (BMI 19 - 29), with lean mass below the 90th percentile value
- Coffee drinkers with an average consumption of 1-3 cups per day
- Having given informed consent
- VO2 max as a function of age and gender, not higher than the values below:
Max oxygen uptake (VO2max, in ml/kg/min) in non athletes Age Males Females 20-29 49 41 30-39 47 39 40-49 45 37
Exclusion Criteria:
- Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, cholesterol, LDL, HDL, triglycerides, aspartate transaminase (ASAT), Alanine transaminase (ALAT), C reactive Protein (CRP), creatinin)
Subjects at cardio-vascular risk rated as intermediate or high (according to the Swiss Society of Cardiology, lipids group (www.agla.ch/p11-1-2.html), meaning those who show at least one of the following criteria:
- History of coronary disease / atherosclerosis
- Diabetes
- High level of risk (familial hypercholesterolemia, hyperlipoproteinemia type III, hypertension)
- Metabolic syndrome defined by the presence of at least 3 out of the following criteria :
Abdominal circumference > 102 cm in men, > 88 cm in women Fasting triglycerides ≥ 1.7 mmol/l HDL-cholesterol < 1.0 mmol/l in men, < 1.3 mmol/l in women Systolic arterial blood pressure ≥ 130 mm Hg and/or diastolic arterial blood pressure ≥ 85 mm Hg Plasma glucose ≥ 6.1 mmol/l
- Anemia (Erythrocytes < 4.6 T/l (male) or < 4.2 T/l (women); Hemoglobin Hb < 13 g/dl (male) or Hb < 12 g/dl (women); Hematocrit Ht < 40% (male) or Ht < 37% (women); sera iron < 0.6 mg/l or plasma ferritin < 120 microg /l (male) or < 60 microg/l (non menopausal women)
- Troubles of hemostasis as determined by platelets number, prothrombin time and activated partial thromboplastin time
- Have had a gastrointestinal surgery, except appendicectomy
- Pregnancy
- History of food or medication allergy
- Have a regular consumption of medication (only those impacting oxidative stress biomarkers (eg. impacting the metabolism of lipids / LDL / VLDL), oral contraception excepted)
- Have taken antibiotic therapy within the last 3 months
- Smokers (more than 5 cigarettes per day)
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- Have a high alcohol consumption (more than 2 drinks/day)
- Taking more than 3 cups of coffee per day
- Consumption of illicit drugs
- Subject who cannot be expected to comply with the study procedures, including consuming the test products.
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:coffee
4 cups of soluble coffee per day (2.5g per cup)
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maltodextrine with caffeine
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安慰剂比较:Maltodextrine with caffeine
4 cups per day containing 2.5 g of product each
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coffee versus placebo
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
oxidative stress
大体时间:Change in oxidative stress from baseline to the last day of a 14-day period of product intake
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Oxidative stress will be assessed though urine beta-isoprostane measurements
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Change in oxidative stress from baseline to the last day of a 14-day period of product intake
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Bioavailability of coffee antioxidative compounds
大体时间:Change in urine phenolic and chlorogenic acids from baseline to the last day of a 14-day period of product intake
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Measures of phenolic and chlorogenic acids in urine
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Change in urine phenolic and chlorogenic acids from baseline to the last day of a 14-day period of product intake
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合作者和调查者
调查人员
- 首席研究员:Maurice Beaumont, MD、Clinical Development Unit / Metabolic Unit
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 10.38.MET
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Placebo comparator的临床试验
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Mila (bMotion Technologies)完全的