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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33178
Enrollment
32
Registered
2009-07-09
Start date
2009-09-07
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

niet van toepassing inflammation oxidative stress recovery resilience

Interventions

Intervention: each intervention lasts four weeks: * High Vegetable treatment: consumption of 200 grams of vegetables daily
* Low Vegetable treatment: consumption of 50 grams of vegetables daily
* An energy restricted diet intervention with the habitual vegetable consumption.

Sponsors

Ministerie van Volksgezondheid, Welzijn en Sport (VWS)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 = 30 and

Exclusion criteria

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 (

Design outcomes

Primary

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

Secondary

MeasureTime frame
Additional blood variables. Effect of body weight loss on these parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)