Vegetable Consumption in Relation to Health

Obesity Clinical Trial

— 8374  

Official title:

Beneficial Effects of Vegetable Consumption and a Diet Intervention on Health in Lean and Obese Men.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959790
• Other study ID #: P8374
• Status: Completed
• Phase: N/A
• First received: August 14, 2009
• Last updated: February 27, 2012
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2012
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care InspectorateNetherlands: Medical Ethics Review Committee (METC)Netherlands: Ministry of Health, Welfare and SportNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 between 18 and 45 years at Day 01 of the study

3. Body Mass Index (BMI): for the lean : between 20 and 25 kg/m2; obese between 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Health
• Obesity
• Oxidative Stress

Intervention

Dietary Supplement:
• Vegetables
200 or 50 grams of vegetables daily for four weeks
• energy restriction
Consume about 1000 kcal less daily, for four weeks, as a positive control to the vegetables interventions.

Locations

Country	Name	City	State
Netherlands	TNO Quality of Life, Metabolic ward	Zeist	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
TNO	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No