Clinical trial NCT03330548: Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
Official title: Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Overweight and Obesity
Diabetes
Keywords: Plant-based diet
Hyperlipidemia
Diabetes
Overweight
Veterans
Lead sponsor: Phoenix VA Health Care System
Sponsor class: FED
Collaborators: name: Rouxbe Online Culinary School
name: Carl T. Hayden Medical Research Foundation
First posted: 2017-11-06
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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).

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.

Primary outcomes:
measure: Change in Low-density lipoprotein (LDL)
timeFrame: 90 days, 6 months and one year from baseline
Secondary outcomes:
measure: Change in Dietary pattern
timeFrame: 90 days, 6 months and one year from baseline
measure: Change in carotid plaque
timeFrame: 90 days from baseline
measure: Change in aortic pulse wave velocity
timeFrame: 90 days from baseline
measure: Change in Total Cholesterol
timeFrame: 90 days, 6 months and one year from baseline
measure: Change in Weight
timeFrame: 90 days, 6 months and one year from baseline
measure: Change in Hemoglobin A1C (HgbA1c)
timeFrame: 90 days, 6 months and one year from baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System
state: Arizona
Study officials:
affiliation: Phoenix VA Health Care System
name: Diane J Parrington, PhD
role: PRINCIPAL_INVESTIGATOR
References: