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

Not Applicable

Completed

• Conditions: Hyperlipidemias; Diabetes; Overweight and Obesity
• Interventions: Behavioral: TeleMOVE!; Behavioral: Culinary Rx

• Registration Number: NCT03330548
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2015-07-09
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Status Verified: 2021-03
• Primary Completion: 2021-03-05
• Study Completion: 2021-03-05
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TeleMOVE!	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
Culinary Rx	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.

Primary Outcome Measures

Name	Time	Method
Change in Low-density lipoprotein (LDL)	90 days, 6 months and one year from baseline	Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)

Secondary Outcome Measures

Name	Time	Method
Change in Weight	90 days, 6 months and one year from baseline	Weight in kilograms measured with subject in light clothing without shoes
Change in carotid plaque	90 days from baseline	Plaque volume
Change in Hemoglobin A1C (HgbA1c)	90 days, 6 months and one year from baseline	Hemoglobin A1c measured as %
Change in Total Cholesterol	90 days, 6 months and one year from baseline	Fasting total cholesterol measured in milligrams per deciliter (mg/dl)
Change in Dietary pattern	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.
Change in aortic pulse wave velocity	90 days from baseline	aortic pulse wave velocity

Trial Locations

Locations (1)

Phoenix VA Health Care System; 🇺🇸 Phoenix, Arizona, United States