Status:
COMPLETED
Coffee and In-vivo Oxidative Stress
Lead Sponsor:
TNO
Collaborating Sponsors:
Mondelēz International, Inc.
Conditions:
Healthy
Eligibility:
All Genders
35-65 years
Phase:
PHASE2
Brief Summary
Food and beverage intake that leads to a decrease in the level of in vivo markers of oxidative stress indicates that such foods and beverages act as antioxidants (AOX) in humans. Coffee drinking at a ...
Detailed Description
Objective: The main objective of the present study is to determine the short- and mid-term effects of a coffee, on oxidative stress parameters in humans. Study design: randomized, placebo-controlled,...
Eligibility Criteria
Inclusion
- Healthy as assessed by the
- health and lifestyle questionnaire, (P8353 F02; in Dutch)
- results of the pre-study laboratory tests
- Males and females aged \>= 35 and \<= 65 years at Week 01 of the study
- Body Mass Index (BMI) \>= 20.0 but \<= 34.9 kg/m2
- Blood pressure (automated measurement at site): systolic blood pressure \<= 139 mm Hg and diastolic blood pressure \<= 89 mm Hg
- Fasting glucose \<= 6.9 mmol/L
- No smoking or moderate smoking of 1 to 19 cigarettes per day, with the proportion of smokers and nonsmokers representative of the European adult population aged 35-65 years
- Normal European eating habits as assessed by P8353 F02. Fruit and vegetable consumption at a level representative or less for the European population as assessed by P8353 F06
- Habitual caffeinated coffee drinker who consumes \> 1 cup per day on at least 5 days per week as assessed by P8353 F02
- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion
- Subjects with one or more of the following characteristics will be excluded from participation:
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome (including cardiovascular disease or hypertension at repeated measurements, hypercholesterolemia, hyperglycaemia, kidney or liver disease, cancer, mental illness) based on the health questionnaire
- Hypertension as indicated by a systolic BP \>= 140 mm Hg or a diastolic BP \>= 90 mm Hg
- Hypercholesterolemia as indicated by a fasting LDL-cholesterol \>= 4.9 mmol/L at a single screening visit or the use of anti-hypercholesterolemia drugs
- Diabetes as indicated by a fasting blood glucose \>= 7.0 mmol/L at a single screening visit
- Having (a history of) (severe) gastro-intestinal complaints
- Using medication for high blood pressure, high cholesterol level, gastro-intestinal complaints, or antidepressants. With the exception of medication for heartburn
- Not willing to give up the use of coffee, tea, dark chocolate (and foods/beverages containing dark chocolate), vitamin supplements, mineral supplements, herbal products (food, beverage, or supplements), antioxidant dietary supplements, omega-3 fatty acid supplements including flaxseed oil and fish oil supplements, red wine or rose wines, port, sherry, or specific fortified foods
- Not willing to give up the consumption of coffee beans as food or in foods or the consumption of coffee or espresso in foods (e.g. Tiramisu)
- The use of any non-study caffeinated/decaffeinated coffee beverage or caffeinated/decaffeinated espresso-based beverage (espresso, cappuccino, latte, frappuccino, or frappe
- Alcohol consumption \> 28 units/week for males and \> 21 units/week for females
- Eating lots of fruit and vegetables (i.e. more than 400 gram vegetables per day and more than 4 servings of fruit per day at screening and during the study. This is twice that of the Dutch dietary recommendations for fruit and vegetable intake)
- Changing smoking habits (\> 5 cigarettes per day)
- Exercising heavily (\> 7 hours/week)
- Not willing to give up supplement (antioxidant containing) use (to be specified)
- Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Reported vegan, vegetarian or macrobiotic
- Recent blood donation (\<1 month prior to the start of the study)
- Not willing to give up blood donation during the study.
- Pregnant or lactating or wishing to become pregnant in the period of the study
- Personnel of TNO Quality of Life, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00868205
Start Date
March 1 2009
End Date
March 1 2010
Last Update
February 28 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
TNO Quality of Life
Zeist, Utrecht, Netherlands, 3700 AJ