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Clinical 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. In addition to more traditional markers (cholesterol, blood pressure, inflammation), endothelial progenitor cells and trimethylamine N-oxide will be assessed.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05414851
Study type Interventional
Source University of Rochester
Contact
Status Active, not recruiting
Phase N/A
Start date December 20, 2022
Completion date June 1, 2024

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