Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Evening meal challenge; Other: Morning meal challenge

• Registration Number: NCT05987566
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Study Start: 2023-09-11
• Status Verified: 2024-03
• Primary Completion: 2024-03-06
• Study Completion: 2024-03-06
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Late Night Meal Challenge	Evening meal challenge	-
Morning Meal Challenge	Morning meal challenge	-

Primary Outcome Measures

Name	Time	Method
Urinary sodium excretion and markers of kidney injury	24 hours	Day and nocturnal urinary sodium, NGAL and KIM-1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth Univesity; 🇺🇸 Richmond, Virginia, United States