Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Hypertension Clinical Trial

Official title:

Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987566
• Other study ID #: HM20026660
• Status: Completed
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: March 6, 2024

Study information

• Verified date: March 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 6, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Virginia Commonwealth Univesity	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary sodium excretion and markers of kidney injury	Day and nocturnal urinary sodium, NGAL and KIM-1	24 hours
Secondary	24hr ambulatory blood pressure	Day and nocturnal ambulatory blood pressure	24 Hours
Secondary	Macrovascular function	Brachial artery endothelial function assessed by flow mediated dilation	At baseline and after each 24hour experimental arm
Secondary	Microvascular function	Skin blood flow response to local heating measured by laser doppler flowmetry	At baseline and after each 24hour experimental arm