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CompletedNCT03330548Updated Mar 11, 2021

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

An interventional study of TeleMOVE! and Culinary Rx in Hyperlipidemias, Overweight and Obesity and Diabetes, sponsored by Phoenix VA Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by Phoenix VA Health Care System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the detailed description

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. The specific aims are to conduct a preliminary examination of:

  1. The feasibility of Veterans to adopt a whole-food, plant-strong diet within five weeks, following a plant-strong protocol, or within 90 days following a Plant Strong Diet (PSD) using Culinary Rx, or by TeleMOVE! (standard of care control). Feasibility factors will evaluate acceptability and practicality by a measure of the recruitment process, attrition rate, reasons for dropping, perceived benefit, and comparison of dietary pattern changes before and after the intervention.

    a. Acceptability of a plant-strong diet.

  2. (Part 1) The effectiveness of a five-week whole-food, plant-strong diet on participants':

    1. Cardiovascular risk factors: Low-Density Lipoprotein, (LDL-C), High-Density Lipoprotein (HDL), Triglycerides (TG), Total Cholesterol (T Chol), C-Reactive Protein (CRP), basic chemistry panel, blood pressure, weight, waist circumference, and percent body fat.
    2. Dietary pattern, particularly the 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-food) are increased from baseline intake, and the nutrient composition (percent of calories from protein, fat, carbohydrate, and amount of fiber) of the diet changes.
  3. (Part 3) The effectiveness of completing Culinary Rx as compared to TeleMOVE! for 90 days on participants':

    1. Cardiovascular risk factors: Low-Density Lipoprotein, (LDL-C), High-Density Lipoprotein (HDL), Triglycerides (TG), Total Cholesterol (T Chol), HgbA1c, blood pressure, body mass index, weight, waist to hip ratio, and. medication usage (e.g., blood pressure, hypoglycemic, lipid lowering and anti-depressants).
    2. Dietary pattern, particularly the 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-food) are increased from baseline intake, and the nutrient composition (percent of calories from protein, fat, carbohydrate, and amount of fiber) of the diet changes.
    3. Long-term lifestyle changes as measured by sustainability of dietary pattern and cardiovascular risk changes that occurred at 90 days and were still present at six months and one year, (excluding change in plaque inflammation and endothelial function).
  4. Establish the ability of Positron Emission Tomography 18F-fluorodeoxyglucose radiopharmaceutical and magnetic resonance imaging (PET FDG-MRI) to assess serial change in plaque inflammation and plaque volume (Part 2) and then perform a pilot test to assess whether a 90-day PSD using Culinary Rx, or TeleMOVE! reduces plaque inflammation using FDG uptake on PET scan and structural changes on MRI (Part 3).

    1. Correlation analysis of aortic/carotid FDG uptake versus Framingham risk score from consecutive subjects who underwent PET FDG for clinical indications at Phoenix VA from January 1, 2010-May 31, 2015.
    2. Change in aortic/carotid plaque FDG uptake, plaque volume and aortic pulse wave velocity (measure of aortic/arterial stiffness) at baseline and following 90-day PSD using Culinary Rx, or TeleMOVE! (pilot prospective study).
02

Conditions studied

  • Hyperlipidemias
  • Overweight and Obesity
  • Diabetes

Keywords

  • Plant-based diet
  • Hyperlipidemia
  • Diabetes
  • Overweight
  • Veterans
03

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
87 participants (actual)

Study arms

  • 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!

  • 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

Interventions

  • BehavioralTeleMOVE!

    Active comparator- telehealth treatment program for weight management and health promotion

  • BehavioralCulinary Rx

    Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.

05

What researchers measure

Primary outcomes

  1. Change in Low-density lipoprotein (LDL)

    Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)

    Time frame: 90 days, 6 months and one year from baseline

Secondary outcomes

  1. Change in Dietary pattern

    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.

    Time frame: 90 days, 6 months and one year from baseline

  2. Change in carotid plaque

    Plaque volume

    Time frame: 90 days from baseline

  3. Change in aortic pulse wave velocity

    aortic pulse wave velocity

    Time frame: 90 days from baseline

  4. Change in Total Cholesterol

    Fasting total cholesterol measured in milligrams per deciliter (mg/dl)

    Time frame: 90 days, 6 months and one year from baseline

  5. Change in Weight

    Weight in kilograms measured with subject in light clothing without shoes

    Time frame: 90 days, 6 months and one year from baseline

  6. Change in Hemoglobin A1C (HgbA1c)

    Hemoglobin A1c measured as %

    Time frame: 90 days, 6 months and one year from baseline

06

Study locations

1 site
  • Phoenix VA Health Care System
    Phoenix, Arizona 85012, United States
07

References and documents

Individual participant data

Plan to share: No — The study start date was before January 18, 2017, so no plan is in place.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03330548
Lead sponsor
Phoenix VA Health Care System
Collaborators
Rouxbe Online Culinary School, Carl T. Hayden Medical Research Foundation
Responsible party
Diane Parrington (Deputy Associate Chief of Staff for Research, Phoenix VA Health Care System) — Principal investigator
First posted
Nov 6, 2017
Start date
Jul 9, 2015
Primary completion
Mar 5, 2021
Completion
Mar 5, 2021
Last update
Mar 11, 2021

Study contacts

Diane J Parrington, PhD
principal investigator · Phoenix VA Health Care System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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