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OpenTrials
Completed

NCT Number: NCT00874341

Effect of Fruit and Vegetables on Insulin Resistance

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Queen's University Belfast, Belfast, Northern Ireland, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Insulin resistance (two-step euglycaemic-hyperinsulinaemic clamp)

    Time frame: Start and end of 12 week intervention

Secondary outcomes

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

    Time frame: Start and end of 12 week intervention

  2. Cardiovascular risk factors

    Time frame: Start and end of 12 week intervention

  3. Biochemical markers of nutritional status

    Time frame: Start and end of 12 week intervention

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Official study title

Dose-Response Effect of Fruit and Vegetables on Insulin Resistance in Healthy People Who Are Overweight and at High Risk of Cardiovascular Disease

Acronym: FIRST

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2009
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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