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OpenTrials
Completed

NCT Number: NCT04036773

Food Pharmacy at Oregon Health & Science University (OHSU) Knight Cardiovascular Institute (KCVI)

Participants in the intervention group of this study will receive weekly home deliveries of fruit & vegetables for 3 months. The primary objective of this study is to determine if increased access to fruits and vegetables leads to sustained dietary changes, measured through changes in the Healthy Eating Index (HEI). Secondary objectives are to determine whether increased fruit and vegetable access (increased HEI) ultimately leads to improved cardiovascular (CV) health indicators (e.g., body mass index, waist circumference, blood pressure, and levels of blood lipids and hemoglobin A1c).

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 19 years and older
  • Established patient at OHSU Center for Preventive Cardiology
  • Not requiring changes to medication regimen for the 6-month study duration
  • Must be eligible to register with produce delivery company (reside in Portland-metro area; have access to a computer with internet service; able to read English)

Exclusion criteria

  • Triglycerides > 500 mg/dL
  • Heavy alcohol use (> 3 drinks/day)
  • Uncontrolled hypertension (BP > 140/90)
  • LDL-C > 160 mg/dL
  • Uncontrolled diabetes mellitus (HbA1c > 8%)
  • Failure to provide informed consent
  • Current pregnancy
  • Healthy Eating Index (HEI) score of ≥ 80

Treatment and study plan

Fruit and vegetable deliveries

Dietary Supplement

Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables

Primary outcomes

  1. Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)

    Time frame: 6 months

    The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans.

Secondary outcomes

  1. Changes in weight measured by body mass index

    Time frame: 6 months

    weight and height will be combined to report BMI in kg/m^2

  2. Changes in waist circumference

    Time frame: 6 months

    Waist circumference will be measured in inches using a tape measure; desirable: < 40 inches (men), < 35 inches (women)

  3. Changes in total cholesterol

    Time frame: 6 months

    measured via blood draw, desirable < 200 mg/dL

  4. Changes in HDL-cholesterol

    Time frame: 6 months

    measured via blood draw, desirable > 40 mg/dL

  5. Changes in LDL-cholesterol

    Time frame: 6 months

    measured via blood draw, desirable < 100 mg/dL

  6. Changes in triglycerides

    Time frame: 6 months

    measured via blood draw, desirable < 150 mg/dL

  7. Changes in blood pressure

    Time frame: 6 months

    Measured by medical assistant in clinic, desirable < 120/80 mmHg

  8. Changes in blood glucose

    Time frame: 6 months

    measured via blood draw, desirable range is 60-99 mg/dL

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2019
Registry last updated
Apr 20, 2022

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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