Status:
COMPLETED
Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
Lead Sponsor:
Phoenix VA Health Care System
Collaborating Sponsors:
Rouxbe Online Culinary School
Carl T. Hayden Medical Research Foundation
Conditions:
Hyperlipidemias
Overweight and Obesity
Eligibility:
All Genders
18-89 years
Phase:
NA
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 cardiova...
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 cardiova...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03330548
Start Date
July 9 2015
End Date
March 5 2021
Last Update
March 11 2021
Active Locations (1)
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1
Phoenix VA Health Care System
Phoenix, Arizona, United States, 85012