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Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330548
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : January 29, 2020
Sponsor:
Collaborators:
Rouxbe Cooking School
Carl T. Hayden Medical Research Foundation
Information provided by (Responsible Party):
Diane Parrington, Phoenix VA Health Care System

Brief Summary:
The purpose of this study is to conduct a preliminary test of the effectiveness of various educational interventions to promote adoption of a whole-food, plant-strong diet and reduce specific cardiovascular risk factors in Veterans, and subsequently perform a preliminary pilot study on whether this dietary approach will change plaque inflammation and endothelial function.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Overweight and Obesity Diabetes Behavioral: TeleMOVE! Behavioral: Culinary Rx Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized 2:1 into Culinary Rx or TeleMOVE! prior to baseline measures. We plan to enroll a subset of the 80 participants to undergo a PET-MRI sub-study (total of 21 participants). This cohort requires participants to have a pooled cohort risk score of ≥ 7.5%, be willing and able to undergo FDG-PET-MRI. [The ACC/AHA pooled risk calculator utilizes information such as age, lipid profile, hypertension to estimate 10 year risk of ASCVD.
Masking: Single (Outcomes Assessor)
Masking Description: The assessor for the imaging studies will be blinded to the study arms of the subjects.
Primary Purpose: Treatment
Official Title: Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
Actual Study Start Date : July 9, 2015
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Active Comparator: TeleMOVE!
Veterans randomized to the control arm will participate in TeleMOVE!, an arm of the Management of Overweight Veterans (MOVE!) program. TeleMOVE! is telehealth treatment program within the VA designed to improve the lives of Veterans by assisting with weight management and health promotion. This program includes daily interaction with in-home messaging technologies and clinician contact as needed
Behavioral: TeleMOVE!
Active comparator- telehealth treatment program for weight management and health promotion

Experimental: Culinary Rx
Veterans randomized to the experimental arm will participate in Culinary Rx. Culinary Rx is an online instructional cooking and nutrition course that healthcare professionals can prescribe to patients who need to transition away from a Standard American Diet to a more health-supportive, whole foods, plant-based lifestyle. In partnership with The Plantrician Project, this course will focus on teaching the foundational cooking skills needed for long-term behavioral change, coupled with lifestyle education around nutrition and resources that will help users successfully face the many challenges inherent to dietary change.
Behavioral: Culinary Rx
Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.




Primary Outcome Measures :
  1. Change in Low-density lipoprotein (LDL) [ Time Frame: 90 days, 6 months and one year from baseline ]
    Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)


Secondary Outcome Measures :
  1. Change in Dietary pattern [ Time Frame: 90 days, 6 months and one year from baseline ]
    Degree to which meat, fish, dairy and added oils are decreased or eliminated from the dietary pattern; as well as the degree to which the consumption of fruits and vegetables (particularly whole-foods) are increased from baseline intake.

  2. Change in carotid plaque [ Time Frame: 90 days from baseline ]
    Plaque volume

  3. Change in aortic pulse wave velocity [ Time Frame: 90 days from baseline ]
    aortic pulse wave velocity

  4. Change in Total Cholesterol [ Time Frame: 90 days, 6 months and one year from baseline ]
    Fasting total cholesterol measured in milligrams per deciliter (mg/dl)

  5. Change in Weight [ Time Frame: 90 days, 6 months and one year from baseline ]
    Weight in kilograms measured with subject in light clothing without shoes

  6. Change in Hemoglobin A1C (HgbA1c) [ Time Frame: 90 days, 6 months and one year from baseline ]
    Hemoglobin A1c measured as %



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria: U.S. Veterans only

    1. Age >18 and < 90
    2. BMI >25 and < 40
    3. Subject has hypertension, diabetes, hyperlipidemia, or overweight/obesity based upon recognized body mass index (BMI) standards) and an interest and desire to make a lifestyle change.Ability to tolerate two FDG-PET-MRI scans.
    4. Active telephone contact information (either land line or cell phone)
    5. No contraindication to be on a PSD.
    6. Access to transportation and a functioning kitchen
    7. The ability to prepare meals independently.
    8. Access to a computer or tablet with internet access
    9. Digital camera or Smartphone

For the FDG-PET-MRI subset/portion of the study, there are additional inclusion criteria:

Inclusion criteria:

  1. Pooled risk cohort score ≥ 7.5%.
  2. No contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes).

Exclusion Criteria:

  • 1. Significant unplanned weight loss within the last six months 2. BMI < 25 or > 40 3. Uncontrolled insulin-dependent diabetes with a current HbA1C of over 9% 4. Contraindication to undertake a PSD 5. Age <18 years old 6. Pregnancy/lactation 7. Taking prescribed weight loss medication(s) 8. Currently following a plant-strong diet, vegan, or medical weight loss program diet 9. Celiac disease diagnosed within the last six months 10. End-stage hepatic disease or renal disease requiring dialysis 11. Active cancer or receiving chemotherapy or radiation therapy 12. Active alcohol or substance abuse problems 13. History of eating disorders 14. Fasting triglyceride level above 350 mg/dL 15. Any psychological issues that prevent compliance 16. Unable to speak the English language 17. Have limited mobility 18. Homeless or in housing with limited kitchen access

For the FDG-PET-MRI subset/portion of the study, there are additional exclusion criteria:

  1. Inability to tolerate PET scans.
  2. Contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes)
  3. Women of childbearing potential who do not have medical documentation of surgically induced menopause.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330548


Contacts
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Contact: Diane J Parrington, PhD 602-277-5551 ext 7532 diane.parrington@va.gov

Locations
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United States, Arizona
Phoenix VA Health Care System Recruiting
Phoenix, Arizona, United States, 85012
Contact: Diane J Parrington, PhD    602-277-5551 ext 7532      
Sponsors and Collaborators
Phoenix VA Health Care System
Rouxbe Cooking School
Carl T. Hayden Medical Research Foundation
Investigators
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Principal Investigator: Diane J Parrington, PhD Phoenix VA Health Care System
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Responsible Party: Diane Parrington, Deputy Associate Chief of Staff for Research, Phoenix VA Health Care System
ClinicalTrials.gov Identifier: NCT03330548    
Other Study ID Numbers: Parrington1092
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study start date was before January 18, 2017, so no plan is in place.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diane Parrington, Phoenix VA Health Care System:
Plant-based diet
Hyperlipidemia
Diabetes
Overweight
Veterans
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Overweight
Body Weight
Signs and Symptoms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases