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Effect of Fruit and Vegetable Intake on Markers of Fruit and Vegetable Consumption (BIOFAV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01591057
First Posted: May 3, 2012
Last Update Posted: November 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jayne Woodside, PhD, Queen's University, Belfast
  Purpose
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.

Condition Intervention
Healthy 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Increased Fruit and Vegetable Intake on Biomarkers of Fruit and Vegetable Consumption

Further study details as provided by Jayne Woodside, PhD, Queen's University, Belfast:

Primary Outcome Measures:
  • Change in biomarkers of fruit and vegetable consumption [ Time Frame: Baseline and 4 weeks ]

Estimated Enrollment: 30
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Portions Dietary Supplement: 2 portions of fruit and vegetables per day
Consume 2 portions of fruit and vegetables per day
Other Name: 2 portions/day
Experimental: 5 portions Dietary Supplement: 5 portions of fruit and vegetables per day
Consume 5 portions of fruit and vegetables per day
Other Name: 5 portions/day
Experimental: 8 portions Dietary Supplement: 8 portions of fruit and vegetables per day
Consume 8 portions of fruit and vegetables per day
Other Name: 8 portions/day

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591057


Locations
United Kingdom
Queen's University Belfast
Belfast, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Jayne V Woodside, PhD Queen's University, Belfast
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jayne Woodside, PhD, Reader in Clinical Biochemistry, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT01591057     History of Changes
Other Study ID Numbers: 11/07
First Submitted: April 27, 2012
First Posted: May 3, 2012
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Jayne Woodside, PhD, Queen's University, Belfast:
fruit
vegetables
biomarkers
randomised controlled feeding study
Fruit and vegetable intake biomarkers in healthy adults