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Effect of Fruit and Vegetables on Insulin Resistance (FIRST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle McKinley, Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT00874341
First received: April 1, 2009
Last updated: August 19, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
 Other: Fruit and vegetable intervention
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp) [ Time Frame: Start and end of 12 week intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-reported intake of fruit and vegetables (number of portions per day) [ Time Frame: Start and end of 12 week intervention ] [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Time Frame: Start and end of 12 week intervention ] [ Designated as safety issue: No ]
  • Biochemical markers of nutritional status [ Time Frame: Start and end of 12 week intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
1-2 portions of fruit and vegetables daily for 12 weeks
 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)
Active Comparator: 2
4 portions fruit and vegetables daily for 12 weeks
 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)
Active Comparator: 3
7 portions of fruit and vegetables daily for 12 weeks
 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874341

Locations
United Kingdom
Queen's University Belfast
Belfast, Northern Ireland, United Kingdom, BT12 6BJ
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Michelle McKinley, PhD Queens University Belfast
  More Information

No publications provided

Responsible Party: Michelle McKinley, Dr Michelle McKinley, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT00874341     History of Changes
Other Study ID Numbers: FSA study N02042
Study First Received: April 1, 2009
Last Updated: August 19, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen's University, Belfast:
Fruit
Vegetables
Intervention
Insulin resistance
 Cardiovascular disease risk
Dose response
High risk of cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013