HyperlipidemiasNCT03330548
Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
A study testing TeleMOVE! and Culinary Rx in people with Hyperlipidemias and Overweight and Obesity, run by Phoenix VA Health Care System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hyperlipidemias, Overweight and Obesity, Diabetes
- What is being tested?
- TeleMOVE! and Culinary Rx
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2015to 5 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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:
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Phoenix VA Health Care System
Phoenix, Arizona, 85012
About this study
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.
Read the 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.
- Acceptability of a plant-strong diet.
- (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).
- 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.
- 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).
- Conditions
- Hyperlipidemias, Overweight and Obesity, Diabetes
- Being tested
- TeleMOVE!, Culinary Rx
- Keywords
- Plant-based diet, Hyperlipidemia, Diabetes, Overweight, Veterans
- Medical subject headings
- Hyperlipidemias, Overweight, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleMOVE!Behavioural
Active comparator- telehealth treatment program for weight management and health promotion
Culinary RxBehavioural
Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| TeleMOVE! | Active comparator | 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 Receives: Behavioral: TeleMOVE! |
| Culinary Rx | Experimental | 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. Receives: Behavioral: Culinary Rx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Low-density lipoprotein (LDL)
Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)
Measured: 90 days, 6 months and one year from baseline
Secondary outcomes (6)
Change in Dietary pattern
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.
Measured: 90 days, 6 months and one year from baseline
Change in carotid plaque
Plaque volume
Measured: 90 days from baseline
Change in aortic pulse wave velocity
aortic pulse wave velocity
Measured: 90 days from baseline
Change in Total Cholesterol
Fasting total cholesterol measured in milligrams per deciliter (mg/dl)
Measured: 90 days, 6 months and one year from baseline
Change in Weight
Weight in kilograms measured with subject in light clothing without shoes
Measured: 90 days, 6 months and one year from baseline
Change in Hemoglobin A1C (HgbA1c)
Hemoglobin A1c measured as %
Measured: 90 days, 6 months and one year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start9 Jul 2015
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix VA Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Rouxbe Online Culinary School, Carl T. Hayden Medical Research Foundation
- Responsible party
- Principal investigator, Diane Parrington, Phoenix VA Health Care System
- Investigators
- Diane J Parrington, PhD, Principal investigator, Phoenix VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330548
- Sponsor's protocol ID
- Parrington1092
- Status last verified
- Mar 2021
- First submitted
- 25 Oct 2017
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study start date was before January 18, 2017, so no plan is in place.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of a Plant-Strong Diet on Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT03330548
- Acronym / sponsor ID
- Parrington1092
- Conditions
- Hyperlipidemias, Overweight and Obesity, Diabetes
- Keywords
- Plant-based diet, Hyperlipidemia, Diabetes, Overweight, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Phoenix VA Health Care SystemUS federal agency
- Collaborators
- Rouxbe Online Culinary School, Carl T. Hayden Medical Research Foundation
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Acceptability of a plant-strong diet.
- (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).
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TeleMOVE! | Active comparator | Behavioral: 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 | Experimental | Behavioral: Culinary RxVeterans 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleMOVE!Active comparator- telehealth treatment program for weight management and health promotion | Behavioural | TeleMOVE! |
| Culinary RxExperimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle. | Behavioural | Culinary Rx |
Primary outcome
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)
6 secondary outcomes
Change in Dietary pattern
Time frame: 90 days, 6 months and one year from baseline
Change in carotid plaque
Time frame: 90 days from baseline
Change in aortic pulse wave velocity
Time frame: 90 days from baseline
Change in Total Cholesterol
Time frame: 90 days, 6 months and one year from baseline
Change in Weight
Time frame: 90 days, 6 months and one year from baseline
Change in Hemoglobin A1C (HgbA1c)
Time frame: 90 days, 6 months and one year from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No. The study start date was before January 18, 2017, so no plan is in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane J Parrington, PhD principal investigator
Phoenix VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleMOVE! and Culinary Rx in people with Hyperlipidemias and Overweight and Obesity, run by Phoenix VA Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Low-density lipoprotein (LDL) (time frame: 90 days, 6 months and one year from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.