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Completed

NCT Number: NCT05414851

Low-Carbohydrate and Plant-Based Dietary Effects on Vascular Health

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UR Medicine Nutrition in Medicine Research Center

Webster, New York, 14580, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Endothelial Progenitor Cells

    Time frame: 2 weeks

  2. trimethylamine N-oxide

    Time frame: 2 weeks

  3. HDL function

    Time frame: 2 weeks

Secondary outcomes

  1. Cholesterol Panel

    Time frame: 2 weeks

    Total, LDL, HDL, non-HDL cholesterol, and triglycerides

  2. Blood Pressure

    Time frame: 2 Weeks

  3. Resting Heart Rate

    Time frame: 2 weeks

  4. Weight

    Time frame: 2 weeks

  5. Insulin resistance

    Time frame: 2 weeks

    HOMA-IR

  6. Insulin

    Time frame: 2 weeks

  7. Blood Glucose

    Time frame: 2 weeks

  8. Inflammatory Markers

    Time frame: 2 weeks

    hsCRP, TNF-a, IL-6

  9. Satiety Assessment

    Time frame: 2 weeks

    Adapted SLIM (satiety labeled intensity magnitude)

  10. Food "liking"

    Time frame: 2 weeks

    5 food liking factor scales adapted from 5-Factor Satiety Questionnaires

  11. Change in nutritional intake

    Time frame: 2 weeks

    assessed by 3 day food records at baseline and in second week of dietary phase

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Short-term Effects of a Low-carbohydrate Diet and a Whole-food, Plant-based Diet on Newer Markers of Vascular Health

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2022
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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