Chronobiology of Meal Timing: Effects on Vascular and Renal Function
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Sep 2023
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
September 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2024
CompletedMarch 19, 2024
March 1, 2024
6 months
July 31, 2023
March 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Urinary sodium excretion and markers of kidney injury
Day and nocturnal urinary sodium, NGAL and KIM-1
24 hours
Secondary Outcomes (3)
24hr ambulatory blood pressure
24 Hours
Macrovascular function
At baseline and after each 24hour experimental arm
Microvascular function
At baseline and after each 24hour experimental arm
Study Arms (2)
Morning Meal Challenge
EXPERIMENTALLate Night Meal Challenge
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth Univesity
Richmond, Virginia, 232398, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Kirkman
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 14, 2023
Study Start
September 11, 2023
Primary Completion
March 6, 2024
Study Completion
March 6, 2024
Last Updated
March 19, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share