Completed

Coffee and Oxidative Stress During Exercise in Healthy Humans

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Placebo comparator

+ Coffee

Other
Who is being recruted

From 20 to 50 Years
See all eligibility criteria
How is the trial designed

Placebo-Controlled
Interventional
Study Start: March 2012
See protocol details

Summary

Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: April 21, 2014
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: April 21, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

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.
Criteria

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
4 cups of soluble coffee per day (2.5g per cup)

Group II

Placebo
4 cups per day containing 2.5 g of product each

Study 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
CompletedOne Study Center