Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 87
- Locations
- 2
- Primary Endpoint
- Change in Low-density lipoprotein (LDL)
Study Overview
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:
- 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':
-
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.
-
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.
-
(Part 3) The effectiveness of completing Culinary Rx as compared to TeleMOVE! for 90 days on participants':
-
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).
-
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.
-
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).
-
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The assessor for the imaging studies will be blinded to the study arms of the subjects.
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria: U.S. Veterans only
- •Age >18 and < 90
- •BMI >25 and < 40
- •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.
- •Active telephone contact information (either land line or cell phone)
- •No contraindication to be on a PSD.
- •Access to transportation and a functioning kitchen
- •The ability to prepare meals independently.
- •Access to a computer or tablet with internet access
- •Digital camera or Smartphone
- •For the FDG-PET-MRI subset/portion of the study, there are additional inclusion criteria:
- •Inclusion criteria:
- •Pooled risk cohort score ≥ 7.5%.
- •No contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes).
Exclusion Criteria
- •Significant unplanned weight loss within the last six months
- •BMI < 25 or > 40
- •Uncontrolled insulin-dependent diabetes with a current HbA1C of over 9%
- •Contraindication to undertake a PSD
- •Age <18 years old
- •Pregnancy/lactation
- •Taking prescribed weight loss medication(s)
- •Currently following a plant-strong diet, vegan, or medical weight loss program diet
- •Celiac disease diagnosed within the last six months
- •End-stage hepatic disease or renal disease requiring dialysis
- •Active cancer or receiving chemotherapy or radiation therapy
- •Active alcohol or substance abuse problems
- •History of eating disorders
- •Fasting triglyceride level above 350 mg/dL
- •Any psychological issues that prevent compliance
- •Unable to speak the English language
- •Have limited mobility
- •Homeless or in housing with limited kitchen access
- •For the FDG-PET-MRI subset/portion of the study, there are additional exclusion criteria:
- •Inability to tolerate PET scans.
- •Contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes)
- •Women of childbearing potential who do not have medical documentation of surgically induced menopause.
Outcomes
Primary Outcomes
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 Outcomes
- Change in Weight(90 days, 6 months and one year from baseline)
- Change in carotid plaque(90 days from baseline)
- Change in Hemoglobin A1C (HgbA1c)(90 days, 6 months and one year from baseline)
- Change in Total Cholesterol(90 days, 6 months and one year from baseline)
- Change in Dietary pattern(90 days, 6 months and one year from baseline)
- Change in aortic pulse wave velocity(90 days from baseline)
Investigators
Diane Parrington
Deputy Associate Chief of Staff for Research
Phoenix VA Health Care System