Vegetable Consumption in Relation to Health

NCT00959790 | Completed

• 1 other identifier: P8374
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health; Obesity; Oxidative Stress

Keywords

Health; Obesity; Oxidative stress; Challenge concept; Vegetables

Outcome Measures

Primary Outcomes (1)

• 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

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.

  after four weeks of intervention

Study Arms (3)

High vegetable dose

EXPERIMENTAL

Consumption of 200 grams of vegetables daily, for four weeks.

Dietary Supplement: Vegetables

Low vegetable dose

EXPERIMENTAL

Consumption of 50 grams of vegetables daily, for four weeks.

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.

Dietary Supplement: energy restriction

Interventions

Vegetables DIETARY_SUPPLEMENT

200 or 50 grams of vegetables daily for four weeks

High vegetable dose; Low vegetable dose

energy restriction DIETARY_SUPPLEMENT

Consume about 1000 kcal less daily, for four weeks, as a positive control to the vegetables interventions.

Weight loss interventio

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• TNO: lead
• Netherlands: Ministry of Health, Welfare and Sports: collaborator

Study Sites (1)

TNO Quality of Life, Metabolic ward

Zeist, Utrecht, 3700 AJ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 23693065 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Wilrike Pasman, PhD

  TNO

  PRINCIPAL INVESTIGATOR

• Ineke Klöpping-Ketelaars, PhD, MD

  TNO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: TNO, Zeist, The Netherlands

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

NL (1)