Vegetable Consumption in Relation to Health — 8374  

Obesity Clinical Trial

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

Status Completed

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.

Clinical Trial 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

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

• NCT number: NCT00959790
• Study type: Interventional
• Source: TNO
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Completion date: December 2010