NCT05414851Completed
Low-Carbohydrate and Plant-Based Dietary Effects on Vascular Health
Short-term Effects of a Low-carbohydrate Diet and a Whole-food, Plant-based Diet on Newer Markers of Vascular Health
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 2 Jun 2022
- Start date
- 20 Dec 2022
- Primary completion date
- 23 Apr 2024
- Lead sponsor
- University of Rochester
- Diseases
- High blood pressure
- NCT number
- NCT05414851
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 20 Dec 2022 to the primary completion date, 23 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any of the following medications that require close monitoring and adjustment during major dietary change: insulin, sulfonylureas, or warfarin
- Major surgery in the past 3 months
- Illicit drug use (not including marijuana)
Other illness
- Active malabsorption syndrome (celiac disease, history of gastric bypass within the past year, uncontrolled Crohn's disease, protein-losing enteropathy, etc…)
- Diagnosis of cirrhosis or liver failure
- 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
Lab values
- Chronic or acute kidney disease, with eGFR \< 50 on two or more lab tests in the past 6 months
- Hyperkalemia (defined as potassium \>5.4 on two or more lab tests in the past 6 months)
Other
- Consuming a current diet described by the subject as vegetarian, vegan, very low-carbohydrate, or ketogenic
- 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)
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UR Medicine Nutrition in Medicine Research Center Coordinator of this site? Confirm its status | Webster | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.