Heart Disease, IschemicNCT05414851
Low-Carbohydrate and Plant-Based Dietary Effects on Vascular Health
A study testing Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet in people with Heart Disease, Ischemic and Hyperlipidemias, run by University of Rochester at 1 site in United States.
Trial summary
This is a randomized trial with a crossover design to investigate the short-term effects of two different dietary patterns on markers of vascular health. A low-carbohydrate diet and a whole-food, plant-based diet will be used. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Disease, Ischemic, Hyperlipidemias, Hypertension
- What is being tested?
- Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to 23 Apr 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50
- Diagnosis of any of the following cardiovascular risk factors: hypertension (Diagnosis present in chart or use of antihypertensive medications); hyperlipidemia/dyslipidemia (non-HDL cholesterol ≥ 130 within the past year or current use of antihyperlipidemic medication); prediabetes (HbA1c ≥ 5.7% and < 6.5% in the past year); diabetes (HbA1c ≥ 6.5% in the past year); obesity (body mass index ≥ 30).
- Willing and able to comply with the protocol for the duration of the study, including food provision, scheduled meetings and testing visits.
- Able to speak and read English fluently because counseling and education is only available in English.
Who cannot join
- Active malabsorption syndrome (celiac disease, history of gastric bypass within the past year, uncontrolled Crohn's disease, protein-losing enteropathy, etc…)
- Use of any of the following medications that require close monitoring and adjustment during major dietary change: insulin, sulfonylureas, or warfarin
- Chronic or acute kidney disease, with eGFR < 50 on two or more lab tests in the past 6 months
- Diagnosis of cirrhosis or liver failure
- Hyperkalemia (defined as potassium >5.4 on two or more lab tests in the past 6 months)
- Major surgery in the past 3 months
Show all 12Show fewer
- Myocardial infarction in the past 6 months
- Current, active eating disorder as determined by chart review, investigator assessment, or subject history
- Food allergies or intolerances that would interfere with eating study food or require special accommodation as determined by subject history, investigator assessment, or chart review
- Consuming a current diet described by the subject as vegetarian, vegan, very low-carbohydrate, or ketogenic
- Illicit drug use (not including marijuana)
- High risk alcohol use, based on subject history (defined as greater than 7 drinks/week for women and greater than 14 drinks/week for men)
Trial locations and contacts
1 site in 1 country.
United States1 site
UR Medicine Nutrition in Medicine Research Center
Webster, New York, 14580
About this study
Official title: Short-term Effects of a Low-carbohydrate Diet and a Whole-food, Plant-based Diet on Newer Markers of Vascular Health
This is a randomized trial with a crossover design to investigate the short-term effects of two different dietary patterns on markers of vascular health. A low-carbohydrate diet and a whole-food, plant-based diet will be used. In addition to more traditional markers (cholesterol, blood pressure, inflammation), endothelial progenitor cells and trimethylamine N-oxide will be assessed.
Read the detailed description
This study is an investigation of the short-term effects of two different diets on both conventional as well as newer markers of vascular health among subjects over the age of 50 who have a cardiovascular risk factor. The low-carbohydrate diet will be consistent with low-carbohydrate diet maintenance plans, with "net" carbs kept under 50g per day. The whole-food, plant-based diet will exclude animal foods, oils, and solid fats. Meals will be provided, and subjects will consume each diet for 2 weeks, with a 4-6 week washout period between dietary phases. Subjects will be randomized 1:1 to start with either the plant-based diet or the low-carbohydrate diet. Its primary aim is to assess the short-term effect of a whole-food, plant-based diet and a low-carbohydrate diet on levels of endothelial progenitor cells and trimethylamine N-oxide among this population. Secondarily, we will assess more conventional measures of vascular risk, including cholesterol, weight, blood pressure, insulin resistance, and inflammatory marker, as well as fullness and changes in nutritional intake.
- Conditions
- Heart Disease, Ischemic, Hyperlipidemias, Hypertension
- Being tested
- Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet
- Medical subject headings
- Myocardial Ischemia, Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Food, Plant-Based Diet and Low-Carbohydrate DietOther
Participants will consume two weeks of each diet, with a 4-6 week washout period in between. Meals and snacks are provided for convenience to enhance adherence to each dietary pattern, but subjects can add or include their own home-prepared foods as long as they meet dietary guidelines. Each dietary intervention will include an education session via Zoom teleconference, and at least 2 individual contacts by phone to address questions and assess for adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Whole-Food, Plant-Based Start | Experimental | This group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period. Receives: Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet |
| Low-Carbohydrate Start | Experimental | This group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period. Receives: Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Progenitor Cells
Measured: 2 weeks
trimethylamine N-oxide
Measured: 2 weeks
HDL function
Measured: 2 weeks
Secondary outcomes (11)
Cholesterol Panel
Total, LDL, HDL, non-HDL cholesterol, and triglycerides
Measured: 2 weeks
Blood Pressure
Measured: 2 Weeks
Resting Heart Rate
Measured: 2 weeks
Weight
Measured: 2 weeks
Insulin resistance
HOMA-IR
Measured: 2 weeks
Insulin
Measured: 2 weeks
Blood Glucose
Measured: 2 weeks
Inflammatory Markers
hsCRP, TNF-a, IL-6
Measured: 2 weeks
Satiety Assessment
Adapted SLIM (satiety labeled intensity magnitude)
Measured: 2 weeks
Food "liking"
5 food liking factor scales adapted from 5-Factor Satiety Questionnaires
Measured: 2 weeks
Change in nutritional intake
assessed by 3 day food records at baseline and in second week of dietary phase
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start20 Dec 2022
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Disease, IschemicStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- All subjects will consume two separate diets, with a 4-6 washout in between. They will be randomized 1:1 to determine which diet they start with.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas M Campbell, University of Rochester
- Investigators
- Thomas Campbell, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414851
- Sponsor's protocol ID
- RSRB 0007277
- Status last verified
- Jul 2024
- First submitted
- 2 Jun 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of a Low-carbohydrate Diet and a Whole-food, Plant-based Diet on Newer Markers of Vascular Health
- ClinicalTrials.gov ID
- NCT05414851
- Acronym / sponsor ID
- RSRB 0007277
- Conditions
- Heart Disease, Ischemic, Hyperlipidemias, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 10 Jun 2022 (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.
This is a randomized trial with a crossover design to investigate the short-term effects of two different dietary patterns on markers of vascular health. A low-carbohydrate diet and a whole-food, plant-based diet will be used. In addition to more traditional markers (cholesterol, blood pressure, inflammation), endothelial progenitor cells and trimethylamine N-oxide will be assessed.
Detailed description
This study is an investigation of the short-term effects of two different diets on both conventional as well as newer markers of vascular health among subjects over the age of 50 who have a cardiovascular risk factor. The low-carbohydrate diet will be consistent with low-carbohydrate diet maintenance plans, with "net" carbs kept under 50g per day. The whole-food, plant-based diet will exclude animal foods, oils, and solid fats. Meals will be provided, and subjects will consume each diet for 2 weeks, with a 4-6 week washout period between dietary phases. Subjects will be randomized 1:1 to start with either the plant-based diet or the low-carbohydrate diet. Its primary aim is to assess the short-term effect of a whole-food, plant-based diet and a low-carbohydrate diet on levels of endothelial progenitor cells and trimethylamine N-oxide among this population. Secondarily, we will assess more conventional measures of vascular risk, including cholesterol, weight, blood pressure, insulin resistance, and inflammatory marker, as well as fullness and changes in nutritional intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All subjects will consume two separate diets, with a 4-6 washout in between. They will be randomized 1:1 to determine which diet they start with.
| Arm | Type | Receives |
|---|---|---|
| Whole-Food, Plant-Based Start | Experimental | Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate DietThis group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period. |
| Low-Carbohydrate Start | Experimental | Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate DietThis group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >50
- Diagnosis of any of the following cardiovascular risk factors: hypertension (Diagnosis present in chart or use of antihypertensive medications); hyperlipidemia/dyslipidemia (non-HDL cholesterol ≥ 130 within the past year or current use of antihyperlipidemic medication); prediabetes (HbA1c ≥ 5.7% and < 6.5% in the past year); diabetes (HbA1c ≥ 6.5% in the past year); obesity (body mass index ≥ 30).
- Willing and able to comply with the protocol for the duration of the study, including food provision, scheduled meetings and testing visits.
- Able to speak and read English fluently because counseling and education is only available in English.
Key exclusion criteria (12 listed)
- Active malabsorption syndrome (celiac disease, history of gastric bypass within the past year, uncontrolled Crohn's disease, protein-losing enteropathy, etc…)
- Use of any of the following medications that require close monitoring and adjustment during major dietary change: insulin, sulfonylureas, or warfarin
- Chronic or acute kidney disease, with eGFR < 50 on two or more lab tests in the past 6 months
- Diagnosis of cirrhosis or liver failure
- Hyperkalemia (defined as potassium >5.4 on two or more lab tests in the past 6 months)
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 |
|---|---|---|
| Whole-Food, Plant-Based Diet and Low-Carbohydrate DietParticipants will consume two weeks of each diet, with a 4-6 week washout period in between. Meals and snacks are provided for convenience to enhance adherence to each dietary pattern, but subjects can add or include their own home-prepared foods as long as they meet dietary guidelines. Each dietary intervention will include an education session via Zoom teleconference, and at least 2 individual contacts by phone to address questions and assess for adverse events. | Other | Low-Carbohydrate Start, Whole-Food, Plant-Based Start |
Primary outcome
Endothelial Progenitor Cells
Time frame: 2 weeks
trimethylamine N-oxide
Time frame: 2 weeks
HDL function
Time frame: 2 weeks
11 secondary outcomes
Cholesterol Panel
Time frame: 2 weeks
Blood Pressure
Time frame: 2 Weeks
Resting Heart Rate
Time frame: 2 weeks
Weight
Time frame: 2 weeks
Insulin resistance
Time frame: 2 weeks
Insulin
Time frame: 2 weeks
Blood Glucose
Time frame: 2 weeks
Inflammatory Markers
Time frame: 2 weeks
Satiety Assessment
Time frame: 2 weeks
Food "liking"
Time frame: 2 weeks
Change in nutritional intake
Time frame: 2 weeks
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 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Campbell, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet in people with Heart Disease, Ischemic and Hyperlipidemias, run by University of Rochester 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 4 inclusion and 12 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 16 Jul 2024. 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?
Endothelial Progenitor Cells (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 16 Jul 2024.