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Completed

NCT Number: NCT05987566

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth Univesity

Richmond, Virginia, 232398, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morning meal challenge

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

Evening meal challenge

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

Primary outcomes

  1. Urinary sodium excretion and markers of kidney injury

    Time frame: 24 hours

    Day and nocturnal urinary sodium, NGAL and KIM-1

Secondary outcomes

  1. 24hr ambulatory blood pressure

    Time frame: 24 Hours

    Day and nocturnal ambulatory blood pressure

  2. Macrovascular function

    Time frame: At baseline and after each 24hour experimental arm

    Brachial artery endothelial function assessed by flow mediated dilation

  3. Microvascular function

    Time frame: At baseline and after each 24hour experimental arm

    Skin blood flow response to local heating measured by laser doppler flowmetry

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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