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Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987566
Enrollment
15
Registered
2023-08-14
Start date
2023-09-11
Completion date
2024-03-06
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

OTHERMorning 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

OTHEREvening 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

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary sodium excretion and markers of kidney injury24 hoursDay and nocturnal urinary sodium, NGAL and KIM-1

Secondary

MeasureTime frameDescription
24hr ambulatory blood pressure24 HoursDay and nocturnal ambulatory blood pressure
Macrovascular functionAt baseline and after each 24hour experimental armBrachial artery endothelial function assessed by flow mediated dilation
Microvascular functionAt baseline and after each 24hour experimental armSkin blood flow response to local heating measured by laser doppler flowmetry

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026