Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00868205
Eligibility Criteria:
Inclusion Criteria:
1. Healthy as assessed by the
* health and lifestyle questionnaire, (P8353 F02; in Dutch)
* results of the pre-study laboratory tests
2. Males and females aged \>= 35 and \<= 65 years at Week 01 of the study
3. Body Mass Index (BMI) \>= 20.0 but \<= 34.9 kg/m2
4. Blood pressure (automated measurement at site): systolic blood pressure \<= 139 mm Hg and diastolic blood pressure \<= 89 mm Hg
5. Fasting glucose \<= 6.9 mmol/L
6. 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
7. 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
8. Habitual caffeinated coffee drinker who consumes \> 1 cup per day on at least 5 days per week as assessed by P8353 F02
9. Voluntary participation
10. Having given written informed consent
11. Willing to comply with the study procedures
12. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
13. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion Criteria:
Subjects with one or more of the following characteristics will be excluded from participation:
1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
2. 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
3. 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
4. Hypertension as indicated by a systolic BP \>= 140 mm Hg or a diastolic BP \>= 90 mm Hg
5. Hypercholesterolemia as indicated by a fasting LDL-cholesterol \>= 4.9 mmol/L at a single screening visit or the use of anti-hypercholesterolemia drugs
6. Diabetes as indicated by a fasting blood glucose \>= 7.0 mmol/L at a single screening visit
7. Having (a history of) (severe) gastro-intestinal complaints
8. Using medication for high blood pressure, high cholesterol level, gastro-intestinal complaints, or antidepressants. With the exception of medication for heartburn
9. 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
10. 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)
11. The use of any non-study caffeinated/decaffeinated coffee beverage or caffeinated/decaffeinated espresso-based beverage (espresso, cappuccino, latte, frappuccino, or frappe
12. Alcohol consumption \> 28 units/week for males and \> 21 units/week for females
13. 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)
14. Changing smoking habits (\> 5 cigarettes per day)
15. Exercising heavily (\> 7 hours/week)
16. Not willing to give up supplement (antioxidant containing) use (to be specified)
17. Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
18. Reported slimming or medically prescribed diet
19. Reported vegan, vegetarian or macrobiotic
20. Recent blood donation (\<1 month prior to the start of the study)
21. Not willing to give up blood donation during the study.
22. Pregnant or lactating or wishing to become pregnant in the period of the study
23. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
24. Not having a general practitioner
25. 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT00868205
Study Brief:
Protocol Section:
NCT00868205