Effect of Fruit and Vegetables on Insulin Resistance

NCT00874341 | Completed Phase 1

• 1 other identifier: FSA study N02042
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Disease

Keywords

Fruit; Vegetables; Intervention; Insulin resistance; Cardiovascular disease risk; Dose response; High risk of cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)

  Start and end of 12 week intervention

Secondary Outcomes (3)

• Self-reported intake of fruit and vegetables (number of portions per day)

  Start and end of 12 week intervention

• Cardiovascular risk factors

  Start and end of 12 week intervention

• Biochemical markers of nutritional status

  Start and end of 12 week intervention

Study Arms (3)

1

NO INTERVENTION

2

ACTIVE COMPARATOR

4 portions fruit and vegetables daily for 12 weeks

Other: Fruit and vegetable intervention

3

ACTIVE COMPARATOR

7 portions of fruit and vegetables daily for 12 weeks

Other: Fruit and vegetable intervention

Interventions

Fruit and vegetable intervention OTHER

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

2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (2)

Queen's University Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

Royal Victoria Hospital

Belfast, BT12 6BJ, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 24130354 RESULT

• 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.

  PMID: 27175553 DERIVED

• 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.

  PMID: 27004617 DERIVED

• 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.

  PMID: 25972532 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Insulin Resistance

Interventions

Fruit

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Michelle McKinley, PhD

  Queens University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Michelle McKinley

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

GB (2)