NCT05414851

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet	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.

Timeline

• Start date: 2022-12-20
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2022-06-10
• Last updated: 2024-07-16

Locations

1 site across 1 country: United States