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

April 1, 2009
August 19, 2011
January 2009
July 2011   (final data collection date for primary outcome measure)
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp) [ Time Frame: Start and end of 12 week intervention ] [ Designated as safety issue: No ]
Insulin resistance [ Time Frame: Start and end of 12 week intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00874341 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Fruit and Vegetables on Insulin Resistance
Dose−Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Disease
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)
  • No Intervention: 1
    1-2 portions of fruit and vegetables daily for 12 weeks
    Intervention: Other: Fruit and vegetable intervention
  • Active Comparator: 2
    4 portions fruit and vegetables daily for 12 weeks
    Intervention: Other: Fruit and vegetable intervention
  • Active Comparator: 3
    7 portions of fruit and vegetables daily for 12 weeks
    Intervention: Other: Fruit and vegetable intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00874341
FSA study N02042
No
Michelle McKinley, Queen's University, Belfast
Queen's University, Belfast
Not Provided
Principal Investigator: Michelle McKinley, PhD Queens University Belfast
Queen's University, Belfast
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP