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Completed

NCT Number: NCT01591057

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University Belfast

Belfast, BT12 6BJ, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 portions of fruit and vegetables per day

Dietary Supplement

Consume 2 portions of fruit and vegetables per day

Other names: 2 portions/day

5 portions of fruit and vegetables per day

Dietary Supplement

Consume 5 portions of fruit and vegetables per day

Other names: 5 portions/day

8 portions of fruit and vegetables per day

Dietary Supplement

Consume 8 portions of fruit and vegetables per day

Other names: 8 portions/day

Primary outcomes

  1. Change in biomarkers of fruit and vegetable consumption

    Time frame: Baseline and 4 weeks

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Official study title

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

Acronym: BIOFAV

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 3, 2012
Registry last updated
Nov 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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