HypertensionNCT05987566
Chronobiology of Meal Timing: Effects on Vascular and Renal Function
A study testing Morning meal challenge and Evening meal challenge in people with Hypertension, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Morning meal challenge and Evening meal challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth Univesity
Richmond, Virginia, 232398
About this study
The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Morning meal challenge, Evening meal challenge
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning meal challengeOther
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 challengeOther
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
| Study group | Role | What they receive |
|---|---|---|
| Morning Meal Challenge | Experimental | Not described Receives: Other: Morning meal challenge |
| Late Night Meal Challenge | Experimental | Not described Receives: Other: Evening meal challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary sodium excretion and markers of kidney injury
Day and nocturnal urinary sodium, NGAL and KIM-1
Measured: 24 hours
Secondary outcomes (3)
24hr ambulatory blood pressure
Day and nocturnal ambulatory blood pressure
Measured: 24 Hours
Macrovascular function
Brachial artery endothelial function assessed by flow mediated dilation
Measured: At baseline and after each 24hour experimental arm
Microvascular function
Skin blood flow response to local heating measured by laser doppler flowmetry
Measured: At baseline and after each 24hour experimental arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start11 Sep 2023
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Kirkman, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987566
- Sponsor's protocol ID
- HM20026660
- Status last verified
- Mar 2024
- First submitted
- 31 Jul 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronobiology of Meal Timing: Effects on Vascular and Renal Function
- ClinicalTrials.gov ID
- NCT05987566
- Acronym / sponsor ID
- HM20026660
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Meal Challenge | Experimental | Other: Morning meal challenge |
| Late Night Meal Challenge | Experimental | Other: Evening meal challenge |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning meal challengeA 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 | Other | Morning Meal Challenge |
| Evening meal challengeA 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 | Other | Late Night Meal Challenge |
Primary outcome
Urinary sodium excretion and markers of kidney injury
Time frame: 24 hours
Day and nocturnal urinary sodium, NGAL and KIM-1
3 secondary outcomes
24hr ambulatory blood pressure
Time frame: 24 Hours
Macrovascular function
Time frame: At baseline and after each 24hour experimental arm
Microvascular function
Time frame: At baseline and after each 24hour experimental arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Kirkman principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning meal challenge and Evening meal challenge in people with Hypertension, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary sodium excretion and markers of kidney injury (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.