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| Name | Class |
|---|---|
| Netherlands: Ministry of Health, Welfare and Sports | OTHER_GOV |
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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. 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.
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.
Study population: The number of subjects participating in the study will be 32, healthy, lean and obese men, aged between 18-45 years.
Intervention: each intervention lasts four weeks:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High vegetable dose | Experimental | Consumption of 200 grams of vegetables daily, for four weeks. |
|
| Low vegetable dose | Experimental | Consumption of 50 grams of vegetables daily, for four weeks. |
|
| Weight loss interventio | Active Comparator | Consumption of - 1000 kcal daily, for four weeks to be used as a positive control for the vegetables interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vegetables | Dietary Supplement | 200 or 50 grams of vegetables daily for four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigate whether the maximal exercise performance test is a good concept for a challenge test, to examine 'health'. Health is defined as the ability to adapt in different circumstances. | after 4 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Compare outcomes on the exercise test after high or low vegetable consumption and after weight loss. Differences are expected between the lean and obese subjects. | after four weeks of intervention |
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Inclusion Criteria:
Healthy as assessed by the
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilrike Pasman, PhD | TNO | Principal Investigator |
| Ineke Klöpping-Ketelaars, PhD, MD | TNO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TNO Quality of Life, Metabolic ward | Zeist | Utrecht | 3700 AJ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23693065 | Derived | Schoen ED, Rubingh CM, Wopereis S, van Erk M. Controlling false discovery rates in factorial experiments with between-subjects and within-subjects tests. BMC Res Notes. 2013 May 21;6:204. doi: 10.1186/1756-0500-6-204. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014675 | Vegetables |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| energy restriction | Dietary Supplement | Consume about 1000 kcal less daily, for four weeks, as a positive control to the vegetables interventions. |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |