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

Hyperlipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036773
• Other study ID #: 19413
• Status: Completed
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: April 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Fruit and vegetable deliveries
Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI)	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.	6 months
Secondary	Changes in weight measured by body mass index	weight and height will be combined to report BMI in kg/m^2	6 months
Secondary	Changes in waist circumference	Waist circumference will be measured in inches using a tape measure; desirable: < 40 inches (men), < 35 inches (women)	6 months
Secondary	Changes in total cholesterol	measured via blood draw, desirable < 200 mg/dL	6 months
Secondary	Changes in HDL-cholesterol	measured via blood draw, desirable > 40 mg/dL	6 months
Secondary	Changes in LDL-cholesterol	measured via blood draw, desirable < 100 mg/dL	6 months
Secondary	Changes in triglycerides	measured via blood draw, desirable < 150 mg/dL	6 months
Secondary	Changes in blood pressure	Measured by medical assistant in clinic, desirable < 120/80 mmHg	6 months
Secondary	Changes in blood glucose	measured via blood draw, desirable range is 60-99 mg/dL	6 months