UR Medicine Nutrition in Medicine Research Center
Webster, New York, 14580, United States
NCT Number: NCT05414851
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Webster, New York, 14580, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 weeks
Time frame: 2 weeks
Time frame: 2 weeks
Time frame: 2 weeks
Total, LDL, HDL, non-HDL cholesterol, and triglycerides
Time frame: 2 Weeks
Time frame: 2 weeks
Time frame: 2 weeks
Time frame: 2 weeks
HOMA-IR
Time frame: 2 weeks
Time frame: 2 weeks
Time frame: 2 weeks
hsCRP, TNF-a, IL-6
Time frame: 2 weeks
Adapted SLIM (satiety labeled intensity magnitude)
Time frame: 2 weeks
5 food liking factor scales adapted from 5-Factor Satiety Questionnaires
Time frame: 2 weeks
assessed by 3 day food records at baseline and in second week of dietary phase
University of Rochester
Other
Short-term Effects of a Low-carbohydrate Diet and a Whole-food, Plant-based Diet on Newer Markers of Vascular Health
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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