Health8374NCT00959790
Vegetable Consumption in Relation to Health
A study testing Vegetables and energy restriction in people with Health and Obesity, run by TNO at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health, Obesity, Oxidative Stress
- What is being tested?
- Vegetables and energy restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
TNO Quality of Life, Metabolic ward
Zeist, Utrecht, 3700 AJ
About this study
Official title: Beneficial Effects of Vegetable Consumption and a Diet Intervention on Health in Lean and Obese Men.
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.
Read more
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.
Read the 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, aged between 18-45 years.
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.
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.
- Conditions
- Health, Obesity, Oxidative Stress
- Being tested
- Vegetables, energy restriction
- Keywords
- Health, Obesity, Oxidative stress, Challenge concept, Vegetables
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VegetablesDietary supplement
200 or 50 grams of vegetables daily for four weeks
energy restrictionDietary supplement
Consume about 1000 kcal less daily, for four weeks, as a positive control to the vegetables interventions.
| Study group | Role | What they receive |
|---|---|---|
| High vegetable dose | Experimental | Consumption of 200 grams of vegetables daily, for four weeks. Receives: Dietary Supplement: Vegetables |
| Low vegetable dose | Experimental | Consumption of 50 grams of vegetables daily, for four weeks. Receives: Dietary Supplement: Vegetables |
| Weight loss interventio | Active comparator | Consumption of - 1000 kcal daily, for four weeks to be used as a positive control for the vegetables interventions. Receives: Dietary Supplement: energy restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 4 weeks intervention
Secondary outcomes (1)
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.
Measured: after four weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TNO
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Responsible party
- Principal investigator, W.J. Pasman, TNO
- Investigators
- Wilrike Pasman, PhD, Principal investigator, TNOIneke Klöpping-Ketelaars, PhD, MD, Study director, TNO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959790
- Sponsor's protocol ID
- P8374
- Acronym
- 8374
- Status last verified
- Feb 2012
- First submitted
- 14 Aug 2009
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23693065
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Vegetable Consumption and a Diet Intervention on Health in Lean and Obese Men.
- ClinicalTrials.gov ID
- NCT00959790
- Acronym / sponsor ID
- 8374 / P8374
- Conditions
- Health, Obesity, Oxidative Stress
- Keywords
- Health, Obesity, Oxidative stress, Challenge concept, Vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TNOUniversity, hospital or other
- Collaborators
- Netherlands: Ministry of Health, Welfare and Sports
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, aged between 18-45 years.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High vegetable dose | Experimental | Dietary Supplement: VegetablesConsumption of 200 grams of vegetables daily, for four weeks. |
| Low vegetable dose | Experimental | Dietary Supplement: VegetablesConsumption of 50 grams of vegetables daily, for four weeks. |
| Weight loss interventio | Active comparator | Dietary Supplement: energy restrictionConsumption of - 1000 kcal daily, for four weeks to be used as a positive control for the vegetables interventions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegetables200 or 50 grams of vegetables daily for four weeks | Dietary supplement | High vegetable dose, Low vegetable dose |
| energy restrictionConsume about 1000 kcal less daily, for four weeks, as a positive control to the vegetables interventions. | Dietary supplement | Weight loss interventio |
Primary outcome
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.
Time frame: after 4 weeks intervention
1 secondary outcome
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.
Time frame: after four weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Derived from this study: PubMed 23693065Schoen 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.
Related trials for Health
RecruitingObservational study
Reproductive Axis Maturation in the Early Post-Menarchal Years
Reproductive Physiological Processes, Pediatrics
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
RecruitingObservational study
Targeted Health Dialogues in Primary Care
Health Behaviors, Risk Factors
Enrolling by invitation
Techquity by FAITH!
Health Equity, Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilrike Pasman, PhD principal investigator
TNO
Ineke Klöpping-Ketelaars, PhD, MD study director
TNO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetables and energy restriction in people with Health and Obesity, run by TNO at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: after 4 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012; AzTrials last refreshed its copy on 30 Oct 2026.