Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Fruit and Vegetables on Insulin Resistance (FIRST)

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.
ClinicalTrials.gov Identifier: NCT00874341
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Michelle McKinley, Queen's University, Belfast

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 2, 2009
Last Update Posted Date May 8, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp) [ Time Frame: Start and end of 12 week intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Insulin resistance [ Time Frame: Start and end of 12 week intervention ]
Change History Complete list of historical versions of study NCT00874341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fruit and Vegetables on Insulin Resistance
Official Title  ICMJE Dose−Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Disease
Intervention  ICMJE 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)
Study Arms  ICMJE
  • No Intervention: 1
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2015)
105
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2009)
102
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874341
Other Study ID Numbers  ICMJE FSA study N02042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michelle McKinley, Queen's University, Belfast
Study Sponsor  ICMJE Queen's University, Belfast
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle McKinley, PhD Queens University Belfast
PRS Account Queen's University, Belfast
Verification Date May 2015

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