Coffee, Exercise, and Oxidative Stress

NCT01832701 | Completed

• 1 other identifier: 10.38.MET
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (14d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma after an acute stress caused by exercise.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• oxidative stress

  Oxidative stress will be assessed though urine beta-isoprostane measurements

  Change in oxidative stress from baseline to the last day of a 14-day period of product intake

Secondary Outcomes (1)

• Bioavailability of coffee antioxidative compounds

  Change in urine phenolic and chlorogenic acids from baseline to the last day of a 14-day period of product intake

Study Arms (2)

coffee

EXPERIMENTAL

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

Other: Placebo comparator

Maltodextrine with caffeine

PLACEBO COMPARATOR

4 cups per day containing 2.5 g of product each

Other: Coffee

Interventions

Coffee OTHER

coffee versus placebo

Maltodextrine with caffeine

Placebo comparator OTHER

maltodextrine with caffeine

coffee

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Development Unit / Metabolic Unit

Lausanne, 1000, Switzerland

Location

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maurice Beaumont, MD

  Clinical Development Unit / Metabolic Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 16, 2013
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

CH (1)