Effect of Fruit and Vegetables on Insulin Resistance

Phase 1

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: Fruit and vegetable intervention

• Registration Number: NCT00874341
• Lead Sponsor: Queen's University, Belfast

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Fruit and vegetable intervention	4 portions fruit and vegetables daily for 12 weeks
3	Fruit and vegetable intervention	7 portions of fruit and vegetables daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)	Start and end of 12 week intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Queen's University Belfast; 🇬🇧 Belfast, Northern Ireland, United Kingdom

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom