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Chronobiology of Meal Timing: Effects on Vascular and Renal Function

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Hypertension

Treatments

Other: Evening meal challenge
Other: Morning meal challenge

Study type

Interventional

Funder types

Other

Identifiers

NCT05987566
HM20026660

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Morning Meal Challenge
Experimental group
Treatment:
Other: Morning meal challenge
Late Night Meal Challenge
Experimental group
Treatment:
Other: Evening meal challenge

Trial contacts and locations

1

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Central trial contact

Danielle Kirkman; Natalie Bohmke

Data sourced from clinicaltrials.gov

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