Effect of Fruit and Vegetable Intake on Markers of Fruit and Vegetable Consumption

Study Overview
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Brief Summary
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This study will examine what contribution of 'markers' of fruit and vegetable (FV) intake in blood and urine is most closely related to FV intake. 30 healthy volunteers will be fed either 2, 5 or 8 portions of FV per day for 4 weeks (ten participants per group, randomly assigned). Volunteers will have all their food provided during the study, and will consume two meals each weekday at the University. Volunteers will complete diet and lifestyle questionnaires at the start and end of the study and will have blood and urine samples collected at 0, 2 and 4 weeks.

Detailed Description
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Single biomarkers of FV consumption, such as Vitamin C and certain carotenoids and flavonoids, have been proposed, but associations between these compounds and FV intake are relatively weak. The investigators propose that, given the complexity of FV, production of an algorithm based on a wide variety of bioactive compounds found in FV might better predict FV consumption. A controlled feeding study (30 volunteers randomised to 2, 5 or 8 portions of FV day for 4 weeks) will allow development of such an algorithm. Volunteers will be recruited by advertisement from QUB and the general public, and will have all their food provided for the 4 week period (two meals per day during the week to be consumed under supervision at the University).

Official Title
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Effect of Increased Fruit and Vegetable Intake on Biomarkers of Fruit and Vegetable Consumption

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 2 portions of fruit and vegetables per day
* Dietary Supplement: 5 portions of fruit and vegetables per day
* Dietary Supplement: 8 portions of fruit and vegetables per day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years Usual consumption of fruit and vegetables <= 2 portions/day Exclusion Criteria: Use of any high dose vitamin, mineral or dietary supplements Current smoker BMI > 35 kg/m2 Inability to provide informed consent Excessive alcohol consumption (>28 Units/week men or >21 Units/week women) Food sensitivities or allergies that would interfere with a tolerance of a fruit and vegetable rich diet Medical conditions or dietary restrictions that would substantially limit inability to complete the study requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 Portions<br> | Dietary Supplement: 2 portions of fruit and vegetables per day<br>* Consume 2 portions of fruit and vegetables per day<br>* Other names: 2 portions/day;|
| Experimental: 5 portions<br> | Dietary Supplement: 5 portions of fruit and vegetables per day<br>* Consume 5 portions of fruit and vegetables per day<br>* Other names: 5 portions/day;|
| Experimental: 8 portions<br> | Dietary Supplement: 8 portions of fruit and vegetables per day<br>* Consume 8 portions of fruit and vegetables per day<br>* Other names: 8 portions/day;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biomarkers of fruit and vegetable consumption |  | Baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fruit, vegetables, biomarkers, randomised controlled feeding study, Fruit and vegetable intake biomarkers in healthy adults