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

NCT01591057 | Completed DMC

• 1 other identifier: 11/07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

fruit; vegetables; biomarkers; randomised controlled feeding study; Fruit and vegetable intake biomarkers in healthy adults

Outcome Measures

Primary Outcomes (1)

• Change in biomarkers of fruit and vegetable consumption

  Baseline and 4 weeks

Study Arms (3)

2 Portions

EXPERIMENTAL

Dietary Supplement: 2 portions of fruit and vegetables per day

5 portions

EXPERIMENTAL

Dietary Supplement: 5 portions of fruit and vegetables per day

8 portions

EXPERIMENTAL

Dietary Supplement: 8 portions of fruit and vegetables per day

Interventions

2 portions of fruit and vegetables per day DIETARY_SUPPLEMENT

Consume 2 portions of fruit and vegetables per day

Also known as: 2 portions/day

2 Portions

5 portions of fruit and vegetables per day DIETARY_SUPPLEMENT

Consume 5 portions of fruit and vegetables per day

Also known as: 5 portions/day

5 portions

8 portions of fruit and vegetables per day DIETARY_SUPPLEMENT

Consume 8 portions of fruit and vegetables per day

Also known as: 8 portions/day

8 portions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Queen's University Belfast

Belfast, BT12 6BJ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29490640 DERIVED

• 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.

  PMID: 26081648 DERIVED

Study Officials

• Jayne V Woodside, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Clinical Biochemistry

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 3, 2012
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

GB (1)