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Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Primary Purpose

Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Morning meal challenge

Evening meal challenge

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Men and Women aged 18-45 years Elevated (SBP 120-129; DBP <80 mmHg) or stage 1 hypertension (SBP 130-139; DBP 80-89 mmHg) Exclusion Criteria: History of chronic disease (CV, lung, cancer, renal, sleep apnea, diabetes, autoimmune) Anti-hypertensive medication use Currently pregnant or lactating Current shift worker Travel >3 time zones four weeks before the start of the study or during the study Insomnia Practiced intermittent fasting in past six months Current nicotine use Current hormone replacement therapy Current melatonin use Current use of antioxidants and unwilling to stop taking them for the duration of the study Unable to provide informed consent

Sites / Locations

Virginia Commonwealth UnivesityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Morning Meal Challenge

Late Night Meal Challenge

Arm Description

Outcomes

Primary Outcome Measures

Urinary sodium excretion and markers of kidney injury

Day and nocturnal urinary sodium, NGAL and KIM-1

Secondary Outcome Measures

24hr ambulatory blood pressure

Day and nocturnal ambulatory blood pressure

Macrovascular function

Brachial artery endothelial function assessed by flow mediated dilation

Microvascular function

Skin blood flow response to local heating measured by laser doppler flowmetry

Full Information

NCT ID

NCT05987566

First Posted

July 31, 2023

Last Updated

September 27, 2023

Sponsor

Virginia Commonwealth University

1. Study Identification

Unique Protocol Identification Number

NCT05987566

Brief Title

Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Official Title

Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 11, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

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

The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

Detailed Description

Despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in 3 Americans and accounts for more than $50 billion of health care spending. Importantly, hypertension is the leading cause of cardiovascular (CVD) and kidney diseases (CKD). As a result, the AHA/ACC lowered the diagnostic criteria for hypertension to encourage earlier preventative lifestyle intervention. There is a critical need to identify and implement novel lifestyle interventions in individuals with early-stage hypertension to prevent the subsequent development of CVD and CKD. Chronotherapy that aligns behavioral cues (such as time of eating) with the body's internal biological clocks, has gained much attention as a potential strategy to prevent and manage hypertension, however, the underlying mechanisms are not yet fully understood. The purpose of this study is to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

6. Conditions and Keywords

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

Hypertension

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Morning Meal Challenge

Arm Type

Experimental

Arm Title

Late Night Meal Challenge

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Morning meal challenge

Intervention Description

A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten after 1 hour of waking up in the morning

Intervention Type

Other

Intervention Name(s)

Evening meal challenge

Intervention Description

A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten within 1 hour of going to bed

Primary Outcome Measure Information:

Title

Urinary sodium excretion and markers of kidney injury

Description

Day and nocturnal urinary sodium, NGAL and KIM-1

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

24hr ambulatory blood pressure

Description

Day and nocturnal ambulatory blood pressure

Time Frame

24 Hours

Title

Macrovascular function

Description

Brachial artery endothelial function assessed by flow mediated dilation

Time Frame

At baseline and after each 24hour experimental arm

Title

Microvascular function

Description

Skin blood flow response to local heating measured by laser doppler flowmetry

Time Frame

At baseline and after each 24hour experimental arm

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

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

Natalie Bohmke

Phone

(540) 842-9009

bohmkenj@vcu.edu

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

Danielle Kirkman

Phone

dlkirkman@vcu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danielle Kirkman

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth Univesity

City

Richmond

State/Province

Virginia

ZIP/Postal Code

232398

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danielle Kirkman

Phone

302-290-7955

dlkirkman@vcu.edu

First Name & Middle Initial & Last Name & Degree

Natalie Bohmke

Phone

(540) 842-9009

bohmkenj@vcu.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Chronobiology of Meal Timing: Effects on Vascular and Renal Function

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