Effect of Fruit and Vegetables on Insulin Resistance (FIRST)

Q

Queen's University Belfast

Status and phase

Completed
Phase 1

Conditions

Cardiovascular Disease

Treatments

Other: Fruit and vegetable intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT00874341
FSA study N02042

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 3 patient groups

1
No Intervention group
2
Active Comparator group
Description:
4 portions fruit and vegetables daily for 12 weeks
Treatment:
Other: Fruit and vegetable intervention
3
Active Comparator group
Description:
7 portions of fruit and vegetables daily for 12 weeks
Treatment:
Other: Fruit and vegetable intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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