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Clinical Trials/NCT00874341
NCT00874341
Completed
Phase 1

Dose-Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease

Queen's University, Belfast2 sites in 1 country105 target enrollmentJanuary 2009

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
Queen's University, Belfast
Enrollment
105
Locations
2
Primary Endpoint
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
July 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle McKinley

Dr Michelle McKinley

Queen's University, Belfast

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

  • 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
  • Subjects following a weight loss diet

Outcomes

Primary Outcomes

Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)

Time Frame: Start and end of 12 week intervention

Secondary Outcomes

  • Cardiovascular risk factors(Start and end of 12 week intervention)
  • Biochemical markers of nutritional status(Start and end of 12 week intervention)
  • Self-reported intake of fruit and vegetables (number of portions per day)(Start and end of 12 week intervention)

Study Sites (2)

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