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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole-Food, Plant-Based Start | Experimental | This group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period. |
|
| Low-Carbohydrate Start | Experimental | This group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Progenitor Cells | 2 weeks | |
| trimethylamine N-oxide | 2 weeks | |
| HDL function | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol Panel | Total, LDL, HDL, non-HDL cholesterol, and triglycerides | 2 weeks |
| Blood Pressure | 2 Weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Campbell, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UR Medicine Nutrition in Medicine Research Center | Webster | New York | 14580 | United States |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D050171 | Dyslipidemias |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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All subjects will consume two separate diets, with a 4-6 washout in between. They will be randomized 1:1 to determine which diet they start with.
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Laboratory personnel will not know which dietary phase each subject has completed, but otherwise blinding is not possible.
|
| Resting Heart Rate |
| 2 weeks |
| Weight | 2 weeks |
| Insulin resistance | HOMA-IR | 2 weeks |
| Insulin | 2 weeks |
| Blood Glucose | 2 weeks |
| Inflammatory Markers | hsCRP, TNF-a, IL-6 | 2 weeks |
| Satiety Assessment | Adapted SLIM (satiety labeled intensity magnitude) | 2 weeks |
| Food "liking" | 5 food liking factor scales adapted from 5-Factor Satiety Questionnaires | 2 weeks |
| Change in nutritional intake | assessed by 3 day food records at baseline and in second week of dietary phase | 2 weeks |
| D052439 |
| Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |