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CompletedNCT01591057BIOFAVUpdated Nov 27, 2012

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

An interventional study of 2 portions of fruit and vegetables per day and 5 portions of fruit and vegetables per day in Healthy, sponsored by Queen's University, Belfast. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-11-27.

Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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.

Read the 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).

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Conditions studied

  • Healthy

Keywords

  • fruit
  • vegetables
  • biomarkers
  • randomised controlled feeding study
  • Fruit and vegetable intake biomarkers in healthy adults
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In context

Lead sponsor

Queen's University, Belfast is the lead sponsor of 113 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18-65 years
  • Usual consumption of fruit and vegetables \<= 2 portions/day

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    2 Portions

    Dietary Supplement: 2 portions of fruit and vegetables per day

  • Experimental
    5 portions

    Dietary Supplement: 5 portions of fruit and vegetables per day

  • Experimental
    8 portions

    Dietary Supplement: 8 portions of fruit and vegetables per day

Interventions

  • Dietary supplement2 portions of fruit and vegetables per day

    Consume 2 portions of fruit and vegetables per day

    Also known as: 2 portions/day

  • Dietary supplement5 portions of fruit and vegetables per day

    Consume 5 portions of fruit and vegetables per day

    Also known as: 5 portions/day

  • Dietary supplement8 portions of fruit and vegetables per day

    Consume 8 portions of fruit and vegetables per day

    Also known as: 8 portions/day

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What researchers measure

Primary outcomes

  1. Change in biomarkers of fruit and vegetable consumption

    Time frame: Baseline and 4 weeks

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Study locations

1 site
  • Queen's University Belfast
    Belfast, BT12 6BJ, United Kingdom
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References and documents

Publications

  • Appleton KM, McGrath AJ, McKinley MC, Draffin CR, Hamill LL, Young IS, Woodside JV. The value of facial attractiveness for encouraging fruit and vegetable consumption: analyses from a randomized controlled trial. BMC Public Health. 2018 Mar 1;18(1):298. doi: 10.1186/s12889-018-5202-6. PubMed 29490640 ↗
  • McGrath AJ, Hamill LL, Cardwell CR, Draffin CR, Neville CE, Appleton KM, McEneny J, McKinley MC, Young IS, Woodside JV. Combining vitamin C and carotenoid biomarkers better predicts fruit and vegetable intake than individual biomarkers in dietary intervention studies. Eur J Nutr. 2016 Jun;55(4):1377-88. doi: 10.1007/s00394-015-0953-7. Epub 2015 Jun 17. PubMed 26081648 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01591057
Lead sponsor
Queen's University, Belfast
Responsible party
Jayne Woodside, PhD (Reader in Clinical Biochemistry, Queen's University, Belfast) — Principal investigator
First posted
May 3, 2012
Start date
Jun 2011
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Nov 27, 2012

Study contacts

Jayne V Woodside, PhD
principal investigator · Queen's University, Belfast

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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