HyperlipidemiasNCT04036773
Food Pharmacy at Oregon Health & Science University (OHSU) Knight Cardiovascular Institute (KCVI)
A study testing Fruit and vegetable deliveries in people with Hyperlipidemias, run by Oregon Health and Science University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- Fruit and vegetable deliveries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health
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).
- Conditions
- Hyperlipidemias
- Being tested
- Fruit and vegetable deliveries
- Keywords
- diet, nutrition, hyperlipidemia, produce
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit and vegetable deliveriesDietary supplement
Weekly home deliveries of approximately 15 pounds of fresh fruits \& vegetables
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Dietary Supplement: Fruit and vegetable deliveries |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
Changes in weight measured by body mass index
weight and height will be combined to report BMI in kg/m^2
Measured: 6 months
Changes in waist circumference
Waist circumference will be measured in inches using a tape measure; desirable: < 40 inches (men), < 35 inches (women)
Measured: 6 months
Changes in total cholesterol
measured via blood draw, desirable < 200 mg/dL
Measured: 6 months
Changes in HDL-cholesterol
measured via blood draw, desirable > 40 mg/dL
Measured: 6 months
Changes in LDL-cholesterol
measured via blood draw, desirable < 100 mg/dL
Measured: 6 months
Changes in triglycerides
measured via blood draw, desirable < 150 mg/dL
Measured: 6 months
Changes in blood pressure
Measured by medical assistant in clinic, desirable < 120/80 mmHg
Measured: 6 months
Changes in blood glucose
measured via blood draw, desirable range is 60-99 mg/dL
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start14 Oct 2019
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tracy Severson, Oregon Health and Science University
- Investigators
- Tracy Severson, RDN, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036773
- Sponsor's protocol ID
- 19413
- Status last verified
- Apr 2022
- First submitted
- 23 Jul 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Fruit and Vegetable Provision Program on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT04036773
- Acronym / sponsor ID
- 19413
- Conditions
- Hyperlipidemias
- Keywords
- diet, nutrition, hyperlipidemia, produce
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Fruit and vegetable deliveries |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruit and vegetable deliveriesWeekly home deliveries of approximately 15 pounds of fresh fruits \& vegetables | Dietary supplement | Intervention Group |
Primary outcome
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.
8 secondary outcomes
Changes in weight measured by body mass index
Time frame: 6 months
Changes in waist circumference
Time frame: 6 months
Changes in total cholesterol
Time frame: 6 months
Changes in HDL-cholesterol
Time frame: 6 months
Changes in LDL-cholesterol
Time frame: 6 months
Changes in triglycerides
Time frame: 6 months
Changes in blood pressure
Time frame: 6 months
Changes in blood glucose
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Hyperlipidemias
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
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Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Severson, RDN principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruit and vegetable deliveries in people with Hyperlipidemias, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intake of fruits and vegetables measured by changes in Healthy Eating Index (HEI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.