HealthyBIOFAVNCT01591057
Effect of Fruit and Vegetable Intake on Markers of Fruit and Vegetable Consumption
A study testing 2 portions of fruit and vegetables per day, 5 portions of fruit and vegetables per day and 8 portions of fruit and vegetables per day in people with Healthy, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 2 portions of fruit and vegetables per day, 5 portions of fruit and vegetables per day and 8 portions of fruit and vegetables per day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years
- Usual consumption of fruit and vegetables <= 2 portions/day
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Increased Fruit and Vegetable Intake on Biomarkers 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.
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).
- Conditions
- Healthy
- Being tested
- 2 portions of fruit and vegetables per day, 5 portions of fruit and vegetables per day, 8 portions of fruit and vegetables per day
- Keywords
- fruit, vegetables, biomarkers, randomised controlled feeding study, Fruit and vegetable intake biomarkers in healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 portions of fruit and vegetables per dayDietary supplement
Also called 2 portions/day
Consume 2 portions of fruit and vegetables per day
5 portions of fruit and vegetables per dayDietary supplement
Also called 5 portions/day
Consume 5 portions of fruit and vegetables per day
8 portions of fruit and vegetables per dayDietary supplement
Also called 8 portions/day
Consume 8 portions of fruit and vegetables per day
| Study group | Role | What they receive |
|---|---|---|
| 2 Portions | Experimental | Not described Receives: Dietary Supplement: 2 portions of fruit and vegetables per day |
| 5 portions | Experimental | Not described Receives: Dietary Supplement: 5 portions of fruit and vegetables per day |
| 8 portions | Experimental | Not described Receives: Dietary Supplement: 8 portions of fruit and vegetables per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarkers of fruit and vegetable consumption
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayne Woodside, PhD, Queen's University, Belfast
- Investigators
- Jayne V Woodside, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591057
- Sponsor's protocol ID
- 11/07
- Acronym
- BIOFAV
- Status last verified
- Nov 2012
- First submitted
- 27 Apr 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 29490640McGrath 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Increased Fruit and Vegetable Intake on Biomarkers of Fruit and Vegetable Consumption
- ClinicalTrials.gov ID
- NCT01591057
- Acronym / sponsor ID
- BIOFAV / 11/07
- Conditions
- Healthy
- Keywords
- fruit, vegetables, biomarkers, randomised controlled feeding study, Fruit and vegetable intake biomarkers in healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years
- Usual consumption of fruit and vegetables <= 2 portions/day
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 portions of fruit and vegetables per dayAlso: 2 portions/dayConsume 2 portions of fruit and vegetables per day | Dietary supplement | 2 Portions |
| 5 portions of fruit and vegetables per dayAlso: 5 portions/dayConsume 5 portions of fruit and vegetables per day | Dietary supplement | 5 portions |
| 8 portions of fruit and vegetables per dayAlso: 8 portions/dayConsume 8 portions of fruit and vegetables per day | Dietary supplement | 8 portions |
Primary outcome
Change in biomarkers of fruit and vegetable consumption
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 29490640Appleton 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.
- Derived from this study: PubMed 26081648McGrath 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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayne V Woodside, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 portions of fruit and vegetables per day, 5 portions of fruit and vegetables per day and 8 portions of fruit and vegetables per day in people with Healthy, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biomarkers of fruit and vegetable consumption (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01591057, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.