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Effect of Fruit and Vegetables on Insulin Resistance (FIRST)

Primary Purpose

Cardiovascular Disease

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Fruit and vegetable intervention
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring Fruit, Vegetables, Intervention, Insulin resistance, Cardiovascular disease risk, Dose response, High risk of cardiovascular disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Queen's University Belfast
  • Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

4 portions fruit and vegetables daily for 12 weeks

7 portions of fruit and vegetables daily for 12 weeks

Outcomes

Primary Outcome Measures

Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)

Secondary Outcome Measures

Self-reported intake of fruit and vegetables (number of portions per day)
Cardiovascular risk factors
Biochemical markers of nutritional status

Full Information

First Posted
April 1, 2009
Last Updated
May 7, 2015
Sponsor
Queen's University, Belfast
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1. Study Identification

Unique Protocol Identification Number
NCT00874341
Brief Title
Effect of Fruit and Vegetables on Insulin Resistance
Acronym
FIRST
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease
Keywords
Fruit, Vegetables, Intervention, Insulin resistance, Cardiovascular disease risk, Dose response, High risk of cardiovascular disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
4 portions fruit and vegetables daily for 12 weeks
Arm Title
3
Arm Type
Active Comparator
Arm Description
7 portions of fruit and vegetables daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Fruit and vegetable intervention
Intervention Description
Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks)
Primary Outcome Measure Information:
Title
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)
Time Frame
Start and end of 12 week intervention
Secondary Outcome Measure Information:
Title
Self-reported intake of fruit and vegetables (number of portions per day)
Time Frame
Start and end of 12 week intervention
Title
Cardiovascular risk factors
Time Frame
Start and end of 12 week intervention
Title
Biochemical markers of nutritional status
Time Frame
Start and end of 12 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle McKinley, PhD
Organizational Affiliation
Queens University Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University Belfast
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24130354
Citation
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.
Results Reference
result
PubMed Identifier
27175553
Citation
Wallace 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.
Results Reference
derived
PubMed Identifier
27004617
Citation
McEvoy 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.
Results Reference
derived
PubMed Identifier
25972532
Citation
McEvoy 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.
Results Reference
derived

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Effect of Fruit and Vegetables on Insulin Resistance

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