Status:
COMPLETED
Vegetable Consumption in Relation to Health
Lead Sponsor:
TNO
Collaborating Sponsors:
Netherlands: Ministry of Health, Welfare and Sports
Conditions:
Health
Obesity
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
Rationale: Consumption of vegetables is generally considered to be associated with several positive effects on health. Vegetables are a heterogeneous group of our diet which is rich in bio-actives. Th...
Detailed Description
Study design: The study is designed as a randomized, cross-over and parallel, open study. Study population: The number of subjects participating in the study will be 32, healthy, lean and obese men, ...
Eligibility Criteria
Inclusion
- Healthy as assessed by the
- health and lifestyle questionnaire, (P8374 F02; in Dutch)
- physical examination
- results of the pre-study laboratory tests
- Males aged between 18 and 45 years at Day 01 of the study
- Body Mass Index (BMI): for the lean : between 20 and 25 kg/m2; obese between 30 and 35 kg/m2
- Normal Dutch eating habits as assessed by P8374 F02
- Used to consume vegetables daily and liking vegetables (P8374 F02 and F06)
- Physically able to perform a maximal cycling exercise test
- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Appropriate veins for blood sampling according to TNO
- 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
- 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, or inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension and/or (food) allergy
- Using prescribed medication or taking pain killers on a regular basis (judged by the medical investigator) ;
- Smoking
- Exercise regularly and exceed the Dutch Standard of Healthy Physical Activity of 2.5 hours/week
- Alcohol consumption \> 28 units/week
- Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Recent blood donation (\<1 month prior to the start of the study)
- Not willing to give up blood donation during 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 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 :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00959790
Start Date
January 1 2009
End Date
December 1 2010
Last Update
February 28 2012
Active Locations (1)
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1
TNO Quality of Life, Metabolic ward
Zeist, Utrecht, Netherlands, 3700 AJ