Chronobiology of Meal Timing: Effects on Vascular and Renal Function

NCT ID: NCT05987566

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2024-03-06

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Morning Meal Challenge

Group Type: EXPERIMENTAL

Morning meal challenge

Intervention Type: OTHER

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

Late Night Meal Challenge

Group Type: EXPERIMENTAL

Evening meal challenge

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Kirkman

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth Univesity

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20026660

Identifier Type: -

Identifier Source: org_study_id