Coffee and Oxidative Stress During Exercise in Healthy Humans
Placebo comparator
+ Coffee
Summary
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Clinical Development Unit / Metabolic Unit
Lausanne, SwitzerlandOpen Clinical Development Unit / Metabolic Unit in Google Maps