Chronobiology of Meal Timing: Effects on Vascular and Renal Function

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Morning meal challenge; Other: Evening meal challenge

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Bohmke; Phone Number: (540) 842-9009; Email: bohmkenj@vcu.edu
• Study Contact Backup: Name: Danielle Kirkman; Phone Number: dlkirkman@vcu.edu; Email: dlkirkman@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 232398
      • Virginia Commonwealth Univesity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning Meal Challenge	Other: Morning meal challenge; 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
Experimental: Late Night Meal Challenge	Other: Evening meal challenge; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary sodium excretion and markers of kidney injury	Day and nocturnal urinary sodium, NGAL and KIM-1	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr ambulatory blood pressure	Day and nocturnal ambulatory blood pressure	24 Hours
Macrovascular function	Brachial artery endothelial function assessed by flow mediated dilation	At baseline and after each 24hour experimental arm
Microvascular function	Skin blood flow response to local heating measured by laser doppler flowmetry	At baseline and after each 24hour experimental arm

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Danielle Kirkman, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 6, 2024

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HM20026660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No