Status:
COMPLETED
Low-Carbohydrate and Plant-Based Dietary Effects on Vascular Health
Lead Sponsor:
University of Rochester
Conditions:
Heart Disease, Ischemic
Hyperlipidemias
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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, plan...
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 cardiovasc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05414851
Start Date
December 20 2022
End Date
April 23 2024
Last Update
July 16 2024
Active Locations (1)
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1
UR Medicine Nutrition in Medicine Research Center
Webster, New York, United States, 14580