Beneficial effects of vegetable consumption and a diet intervention on health in lean and obese men.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

1. Healthy as assessed by the
- health and lifestyle questionnaire, (P8374 F02; in Dutch)
- physical examination
- results of the pre-study laboratory tests
2. Males aged * 18 and * 45 years at Day 01 of the study
3. Body Mass Index (BMI): for the lean : >= 20 and <= 25 kg/m2; obese >= 30 and <= 35 kg/m2
4. Normal Dutch eating habits as assessed by P8374 F02
5. Used to consume vegetables daily and liking vegetables (P8374 F02 and F06)
6. Physically able to perform a maximal cycling exercise test
7. Voluntary participation
8. Having given written informed consent
9. Willing to comply with the study procedures
10. Appropriate veins for blood sampling according to TNO
11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
12. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

Exclusion Criteria

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, or 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 and/or (food) allergy
4. Using prescribed medication or taking pain killers on a regular basis (judged by the medical investigator) ;
5. Smoking
6. Exercise regularly and exceed the Dutch Standard of Healthy Physical Activity of 2.5 hours/week
7. Alcohol consumption > 28 units/week
8. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
9. Reported slimming or medically prescribed diet
10. Recent blood donation (<1 month prior to the start of the study)
11. Not willing to give up blood donation during the study
12. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
13. Not having a general practitioner
14. 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: A challenge test will be used as a physical<br /><br>stress test to examine whether subjects show more or less resilience to the<br /><br>test. The reaction and recovery of the human system to the exercise test may be<br /><br>used as indicators of health status on different biological analyses<br /><br>(transcriptomics; metabolomics; rules based medicine pm). Different analyses to<br /><br>measure oxidative stress will be performed. Also standard health biomarkers<br /><br>will be determined to examine the intervention effects.</p><br>

Secondary Outcome Measures