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Effect of Fruit and Vegetables on Insulin Resistance (FIRST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874341
First Posted: April 2, 2009
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michelle McKinley, Queen's University, Belfast
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp) [ Time Frame: Start and end of 12 week intervention ]

Secondary Outcome Measures:
  • Self-reported intake of fruit and vegetables (number of portions per day) [ Time Frame: Start and end of 12 week intervention ]
  • Cardiovascular risk factors [ Time Frame: Start and end of 12 week intervention ]
  • Biochemical markers of nutritional status [ Time Frame: Start and end of 12 week intervention ]

Enrollment: 105
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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: April 1, 2009
First Posted: April 2, 2009
Last Update Posted: May 8, 2015
Last Verified: May 2015

Keywords provided by Michelle McKinley, 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