Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
Completed · Not applicable
Conditions studied: Hyperlipidemias, Overweight and Obesity, Diabetes
In brief
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.
Key facts
- Study ID
- NCT03330548
- Run by
- Phoenix VA Health Care System
- People needed
- 87
- Starts
- 2015-07-09
- Expected to finish
- 2021-03-05
- Last updated by the study team
- 2021-03-11
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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:
- 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.
Where it is running
- Phoenix VA Health Care System — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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