The primary objective of the present study is to set-up a methodology to investigate health based on the resilience to challenge. A secondary objective is the effectiveness of the challenge concept with a food intervention. The vegetable…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
niet van toepassing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Additional blood variables.
Effect of body weight loss on these parameters.
Background summary
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. The vegetables contain a range of vitamins,
minerals, dietary fibres and phytochemicals like potassium, flavonoids,
carotenoids, and vitamin C. The recommended intake of vegetables by the Dutch
Health Council is 200 grams daily (Health Council, 2006).
Health in this project is defined as the possibility of a subject to change and
adapt easily in response to a certain challenge. Healthy subjects show
resilience in different physiological processes related to oxidative stress,
metabolic stress, neurological stress and inflammatory stress. The
reaction/response to a challenge might be changed when subjects have consumed
more or less vegetables and have an improved health status. The response might
also differentiate between subjects differing in BMI (healthy weight versus
overweight/obese). Supplementation of vegetables will be provided in two
conditions: a low and a high daily intake (50 versus 200 grams daily). An
intervention known to have positive effects on health is weight loss. This will
be studied in relation to health (the reaction to the challenge test) as well.
A beneficial effect is present when 5% improvement of health markers is shown
with vegetable supplementation, similar as is known from weight loss studies.
Study objective
The primary objective of the present study is to set-up a methodology to
investigate health based on the resilience to challenge. A secondary objective
is the effectiveness of the challenge concept with a food intervention. The
vegetable supplementation study is a first example to test the challenge
concept. Therefore, vegetable consumption according to the recommendations of
the Dutch Health Council of 200 grams of vegetables daily will be studied with
an exercise challenge test, to investigate the beneficial *health* effects.
Study design
The study is designed as a randomized, cross-over and parallel, open study.
Intervention
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.
Study burden and risks
Healthy lean and obese subjects will participate in a vegetable intervention
study to examine the difference in physiological responses due to body weight
differences. Lean and obese subjects might represent a range in disease state,
with the obese being representatives for disease in whom less flexibility to
challenges are expected. In the study subjects undergo three treatments,
lasting four weeks each, therefore they are in study for 12 weeks. After three
weeks abdominal subcutaneous fat samples will be collected. At the end of each
treatment period subjects will visit TNO for a test day. Blood samples will be
drawn and a maximal exercise stress test will be performed in combination with
a sugar test to determine the intestinal permeability. Urine will be collected
for 24 hours after the exercise test and a blood sample will be drawn 24 hours
after exercise as well. No risk or real burden is of concern in this study.
Gedelegeerd sponsor BU Biosciences, PO Box 360
3700 AJ Zeist
Nederland
Gedelegeerd sponsor BU Biosciences, PO Box 360
3700 AJ Zeist
Nederland
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL28861.028.09 |