Effect of Fruit and Vegetables on Insulin Resistance

Cardiovascular Disease Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874341
• Other study ID #: FSA study N02042
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2009
• Last updated: May 7, 2015
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: May 2015
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Insulin Resistance

Intervention

Other:
• Fruit and vegetable intervention
Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks)

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast	Northern Ireland
United Kingdom	Royal Victoria Hospital	Belfast

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University, Belfast

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)		Start and end of 12 week intervention	No
Secondary	Self-reported intake of fruit and vegetables (number of portions per day)		Start and end of 12 week intervention	No
Secondary	Cardiovascular risk factors		Start and end of 12 week intervention	No
Secondary	Biochemical markers of nutritional status		Start and end of 12 week intervention	No