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

NCT05414851 | Completed

• 1 other identifier: RSRB 0007277
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease, Ischemic; Hyperlipidemias; Hypertension

Outcome Measures

Primary Outcomes (3)

• Endothelial Progenitor Cells

  2 weeks

• trimethylamine N-oxide

  2 weeks

• HDL function

  2 weeks

Secondary Outcomes (11)

• Cholesterol Panel

  2 weeks

• Blood Pressure

  2 Weeks

• Resting Heart Rate

  2 weeks

• Weight

  2 weeks

• Insulin resistance

  2 weeks

Study Arms (2)

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.

Other: Whole-Food, Plant-Based Diet and Low-Carbohydrate Diet

Low-Carbohydrate Start

EXPERIMENTAL

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

Interventions

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.

Low-Carbohydrate Start; Whole-Food, Plant-Based Start

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

UR Medicine Nutrition in Medicine Research Center

Webster, New York, 14580, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia; Hyperlipidemias; Hypertension

Interventions

Diet, Plant-Based; Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Thomas Campbell, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory personnel will not know which dietary phase each subject has completed, but otherwise blinding is not possible.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Family Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 10, 2022
• Study Start: December 20, 2022
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (1)