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

Primary Purpose

Heart Disease, Ischemic, Hyperlipidemias, Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Heart Disease, Ischemic

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

UR Medicine Nutrition in Medicine Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Whole-Food, Plant-Based Start

Low-Carbohydrate Start

Arm Description

This group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period.

This group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period.

Outcomes

Primary Outcome Measures

Endothelial Progenitor Cells

trimethylamine N-oxide

HDL function

Secondary Outcome Measures

Cholesterol Panel

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

Blood Pressure

Resting Heart Rate

Weight

Insulin resistance

HOMA-IR

Insulin

Blood Glucose

Inflammatory Markers

hsCRP, TNF-a, IL-6

Satiety Assessment

Adapted SLIM (satiety labeled intensity magnitude)

Food "liking"

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

Change in nutritional intake

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

Full Information

NCT ID

NCT05414851

First Posted

June 2, 2022

Last Updated

December 22, 2022

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT05414851

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Disease, Ischemic, Hyperlipidemias, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

Outcomes Assessor

Masking Description

Laboratory personnel will not know which dietary phase each subject has completed, but otherwise blinding is not possible.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Whole-Food, Plant-Based Start

Arm Type

Experimental

Arm Description

This group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period.

Arm Title

Low-Carbohydrate Start

Arm Type

Experimental

Arm Description

This group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period.

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Endothelial Progenitor Cells

Time Frame

2 weeks

Title

trimethylamine N-oxide

Time Frame

2 weeks

Title

HDL function

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Cholesterol Panel

Description

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

Time Frame

2 weeks

Title

Blood Pressure

Time Frame

2 Weeks

Title

Resting Heart Rate

Time Frame

2 weeks

Title

Weight

Time Frame

2 weeks

Title

Insulin resistance

Description

HOMA-IR

Time Frame

2 weeks

Title

Insulin

Time Frame

2 weeks

Title

Blood Glucose

Time Frame

2 weeks

Title

Inflammatory Markers

Description

hsCRP, TNF-a, IL-6

Time Frame

2 weeks

Title

Satiety Assessment

Description

Adapted SLIM (satiety labeled intensity magnitude)

Time Frame

2 weeks

Title

Food "liking"

Description

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

Time Frame

2 weeks

Title

Change in nutritional intake

Description

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

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lisa Blanchard

Phone

585-279-4681

lisa_blanchard@urmc.rochester.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Campbell, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

UR Medicine Nutrition in Medicine Research Center

City

Webster

State/Province

New York

ZIP/Postal Code

14580

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lisa Blanchard

Phone

585-279-4681

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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