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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UR Medicine Nutrition in Medicine Research Center
Coordinator of this site? Confirm its status
WebsterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.