Effect of Fruit and Vegetables on Insulin Resistance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

4 portions fruit and vegetables daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Fruit and vegetable intervention

Intervention Type OTHER

Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks)

3

7 portions of fruit and vegetables daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Fruit and vegetable intervention

Intervention Type OTHER

Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks)

Interventions

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Fruit and vegetable intervention

Dose-response effect of fruit and vegetable intake (1-2 vs 4 vs 7 portions per day for 12 weeks)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes