We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05414851
Recruitment Status : Not yet recruiting
First Posted : June 10, 2022
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Thomas M Campbell, University of Rochester

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Disease, Ischemic Hyperlipidemias Hypertension Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: Laboratory personnel will not know which dietary phase each subject has completed, but otherwise blinding is not possible.
Primary Purpose: Treatment
Official Title: Short-term Effects of a Low-carbohydrate Diet and a Whole-food, Plant-based Diet on Newer Markers of Vascular Health
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Whole-Food, Plant-Based Start
This group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period.
Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet
Subjects will consume 2 weeks of each diet, with a 4-6 week washout period in between. Meals and snacks are provided for convenience for each dietary pattern. As the each diet is ad libitum, subjects can add or include their own home-prepared foods as long as they meet dietary guidelines.

Experimental: Low-Carbohydrate Start
This group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period.
Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet
Subjects will consume 2 weeks of each diet, with a 4-6 week washout period in between. Meals and snacks are provided for convenience for each dietary pattern. As the each diet is ad libitum, subjects can add or include their own home-prepared foods as long as they meet dietary guidelines.




Primary Outcome Measures :
  1. Endothelial Progenitor Cells [ Time Frame: 2 weeks ]
  2. trimethylamine N-oxide [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05414851


Contacts
Layout table for location contacts
Contact: Lisa Blanchard 585-279-4681 lisa_blanchard@urmc.rochester.edu

Sponsors and Collaborators
University of Rochester
Investigators
Layout table for investigator information
Principal Investigator: Thomas Campbell, MD University of Rochester
Layout table for additonal information
Responsible Party: Thomas M Campbell, Assistant Professor of Family Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT05414851    
Other Study ID Numbers: RSRB 0007277
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Myocardial Ischemia
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases