Cardiovascular DiseasePhase 1FIRSTNCT00874341
Effect of Fruit and Vegetables on Insulin Resistance
A Phase 1 study testing Fruit and vegetable intervention in people with Cardiovascular Disease, run by Queen's University, Belfast at 2 sites in United Kingdom.
Trial summary
Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit and vegetables may be associated with reduced insulin resistance and may reduce the risk of the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Fruit and vegetable intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2009to Jul 2011
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 27-35
- CVD risk >20% over 10 years (using the Joint British Society risk assessment tables)
- Low consumers of fruit and vegetables (<2 portions per day)
Who cannot join
- Diabetes
- Existing CVD
- Food intolerance/sensitivity preventing adherence to a high fruit and vegetable diet
- Subjects taking antioxidant supplements
- Surgery within the last 3 months
- Pregnancy/lactation
- Aspirin
- Subjects following a weight loss diet
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen's University Belfast
Belfast, Northern Ireland, BT12 6BJ
Royal Victoria Hospital
Belfast, BT12 6BJ
About this study
Official title: Dose-Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease
Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit and vegetables may be associated with reduced insulin resistance and may reduce the risk of the metabolic syndrome. If proven, this relationship may partly explain the inverse association between fruit and vegetable intake and cardiovascular disease risk. There are currently no published dietary interventions that have examined in detail the relationship between fruit and vegetable intake and insulin resistance. There is, however, some preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables may have a beneficial effect on insulin resistance. Evidence to date indicates that an investigation of the direct association between fruit and vegetable intakes and insulin resistance in a carefully controlled intervention study is warranted. This study will investigate the dose-response effect of fruit and vegetable intake on insulin resistance in people who are overweight and at high-risk of CVD using state-of-the-art techniques.
- Conditions
- Cardiovascular Disease
- Being tested
- Fruit and vegetable intervention
- Keywords
- Fruit, Vegetables, Intervention, Insulin resistance, Cardiovascular disease risk, Dose response, High risk of cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit and vegetable interventionOther
Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Active comparator | 4 portions fruit and vegetables daily for 12 weeks Receives: Other: Fruit and vegetable intervention |
| 3 | Active comparator | 7 portions of fruit and vegetables daily for 12 weeks Receives: Other: Fruit and vegetable intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)
Measured: Start and end of 12 week intervention
Secondary outcomes (3)
Self-reported intake of fruit and vegetables (number of portions per day)
Measured: Start and end of 12 week intervention
Cardiovascular risk factors
Measured: Start and end of 12 week intervention
Biochemical markers of nutritional status
Measured: Start and end of 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle McKinley, Queen's University, Belfast
- Investigators
- Michelle McKinley, PhD, Principal investigator, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874341
- Sponsor's protocol ID
- FSA study N02042
- Acronym
- FIRST
- Status last verified
- May 2015
- First submitted
- 1 Apr 2009
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wallace IR, McEvoy CT, Hunter SJ, Hamill LL, Ennis CN, Bell PM, Patterson CC, Woodside JV, Young IS, McKinley MC. Dose-response effect of fruit and vegetables on insulin resistance in people at high risk of cardiovascular disease: a randomized controlled trial. Diabetes Care. 2013 Dec;36(12):3888-96. doi: 10.2337/dc13-0718. Epub 2013 Oct 15.
PubMed 24130354Wallace IR, McKinley MC, McEvoy CT, Hamill LL, Ennis CN, McGinty A, Bell PM, Patterson CC, Woodside JV, Young IS, Hunter SJ. Serum 25-hydroxyvitamin D and insulin resistance in people at high risk of cardiovascular disease: a euglycaemic hyperinsulinaemic clamp study. Clin Endocrinol (Oxf). 2016 Sep;85(3):386-92. doi: 10.1111/cen.13100. Epub 2016 Jun 13.
PubMed 27175553McEvoy CT, Wallace IR, Hamill LL, Neville CE, Hunter SJ, Patterson CC, Woodside JV, Chakravarthy U, Young IS, McKinley MC. Increasing fruit and vegetable intake has no effect on retinal vessel caliber in adults at high risk of developing cardiovascular disease. Nutr Metab Cardiovasc Dis. 2016 Apr;26(4):318-25. doi: 10.1016/j.numecd.2015.10.010. Epub 2015 Nov 14.
PubMed 27004617McEvoy CT, Wallace IR, Hamill LL, Hunter SJ, Neville CE, Patterson CC, Woodside JV, Young IS, McKinley MC. Increasing Fruit and Vegetable Intake Has No Dose-Response Effect on Conventional Cardiovascular Risk Factors in Overweight Adults at High Risk of Developing Cardiovascular Disease. J Nutr. 2015 Jul;145(7):1464-71. doi: 10.3945/jn.115.213090. Epub 2015 May 13.
PubMed 25972532
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00874341
- Acronym / sponsor ID
- FIRST / FSA study N02042
- Conditions
- Cardiovascular Disease
- Keywords
- Fruit, Vegetables, Intervention, Insulin resistance, Cardiovascular disease risk, Dose response, High risk of cardiovascular disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Apr 2009 (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.
Current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit and vegetables may be associated with reduced insulin resistance and may reduce the risk of the metabolic syndrome. If proven, this relationship may partly explain the inverse association between fruit and vegetable intake and cardiovascular disease risk. There are currently no published dietary interventions that have examined in detail the relationship between fruit and vegetable intake and insulin resistance. There is, however, some preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables may have a beneficial effect on insulin resistance. Evidence to date indicates that an investigation of the direct association between fruit and vegetable intakes and insulin resistance in a carefully controlled intervention study is warranted. This study will investigate the dose-response effect of fruit and vegetable intake on insulin resistance in people who are overweight and at high-risk of CVD using state-of-the-art techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Active comparator | Other: Fruit and vegetable intervention4 portions fruit and vegetables daily for 12 weeks |
| 3 | Active comparator | Other: Fruit and vegetable intervention7 portions of fruit and vegetables daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 27-35
- CVD risk >20% over 10 years (using the Joint British Society risk assessment tables)
- Low consumers of fruit and vegetables (<2 portions per day)
Key exclusion criteria (8 listed)
- Diabetes
- Existing CVD
- Food intolerance/sensitivity preventing adherence to a high fruit and vegetable diet
- Subjects taking antioxidant supplements
- Surgery within the last 3 months
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 |
|---|---|---|
| Fruit and vegetable interventionDose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks) | Other | 2, 3 |
Primary outcome
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)
Time frame: Start and end of 12 week intervention
3 secondary outcomes
Self-reported intake of fruit and vegetables (number of portions per day)
Time frame: Start and end of 12 week intervention
Cardiovascular risk factors
Time frame: Start and end of 12 week intervention
Biochemical markers of nutritional status
Time frame: Start and end of 12 week intervention
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 8 May 2015.
- Results publication: PubMed 24130354Wallace IR, McEvoy CT, Hunter SJ, Hamill LL, Ennis CN, Bell PM, Patterson CC, Woodside JV, Young IS, McKinley MC. Dose-response effect of fruit and vegetables on insulin resistance in people at high risk of cardiovascular disease: a randomized controlled trial. Diabetes Care. 2013 Dec;36(12):3888-96. doi: 10.2337/dc13-0718. Epub 2013 Oct 15.
- Derived from this study: PubMed 27175553Wallace IR, McKinley MC, McEvoy CT, Hamill LL, Ennis CN, McGinty A, Bell PM, Patterson CC, Woodside JV, Young IS, Hunter SJ. Serum 25-hydroxyvitamin D and insulin resistance in people at high risk of cardiovascular disease: a euglycaemic hyperinsulinaemic clamp study. Clin Endocrinol (Oxf). 2016 Sep;85(3):386-92. doi: 10.1111/cen.13100. Epub 2016 Jun 13.
- Derived from this study: PubMed 27004617McEvoy CT, Wallace IR, Hamill LL, Neville CE, Hunter SJ, Patterson CC, Woodside JV, Chakravarthy U, Young IS, McKinley MC. Increasing fruit and vegetable intake has no effect on retinal vessel caliber in adults at high risk of developing cardiovascular disease. Nutr Metab Cardiovasc Dis. 2016 Apr;26(4):318-25. doi: 10.1016/j.numecd.2015.10.010. Epub 2015 Nov 14.
- Derived from this study: PubMed 25972532McEvoy CT, Wallace IR, Hamill LL, Hunter SJ, Neville CE, Patterson CC, Woodside JV, Young IS, McKinley MC. Increasing Fruit and Vegetable Intake Has No Dose-Response Effect on Conventional Cardiovascular Risk Factors in Overweight Adults at High Risk of Developing Cardiovascular Disease. J Nutr. 2015 Jul;145(7):1464-71. doi: 10.3945/jn.115.213090. Epub 2015 May 13.
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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.
Michelle McKinley, PhD principal investigator
Queens University Belfast
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fruit and vegetable intervention in people with Cardiovascular Disease, run by Queen's University, Belfast at 2 sites 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 3 inclusion and 8 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 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp) (time frame: Start and end of 12 week intervention). 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 NCT00874341, which also lists 4 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 8 May 2015.