Blood PressureNCT04133701

Meal Timing and Blood Pressure

A study testing Time-Restricted Feeding in people with Blood Pressure and Neurovascular Control, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Brain blood flow, blood pressure, and neurovascular control mechanisms will be measured in middle-aged adults before and after a brief intervention period. The intervention will consist of changing the time in which the participant consumes food each day. Read more about this study

Who is it for?: Ages 50 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Blood Pressure, Neurovascular Control
What is being tested?: Time-Restricted Feeding
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 2 Feb 2022to 16 Dec 2022
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 50 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

BMI ≤ 34 kg/m2
Non-smoking
Sedentary or recreationally active
≤ 2 Alcoholic drinks per day
Female subjects: Perimenopausal/Postmenopausal

Who cannot join

History or evidence of hepatic, renal, hematological, peripheral vascular disease, or stroke/neurovascular disease, diabetes, uncontrolled hypertension, sleep apnea
On medications used to treat/manage diseases listed above
Work overnight shifts
Clinically diagnosed anxiety or depression
Pregnant or trying to become pregnant
Significant surgical history
Other significant medical conditions at investigator's discretion

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin-Madison
Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: The Impact of Meal Timing on Neurovascular Control in Adults

Read the detailed description

Healthy adults experience a 10-20% decrease in night-time blood pressure, compared with day-time blood pressure. However, 20-40% of middle-aged adults do not demonstrate a decrease in blood pressure. Abnormal blood pressure patterns are linked to sleep disturbances, hypertension, and associated with elevated cardiovascular risk and mortality. Additionally, abnormal diurnal blood pressure patterns are associated with impaired neurovascular control of the circulation, contributing to an increased risk of hypertension, stroke, and cardiovascular disease. Importantly, midlife is the critical period for implementing interventions to prevent or delay future cardiovascular disease. Recent data demonstrates that time-restricted feeding may normalize blood pressure patterns. The overall goal of this study is to determine if time-restricted feeding normalizes blood pressure patterns and improves neurovascular control.

The research aims are:

To determine the effect of meal timing on blood pressure patterns in middle-aged adults.
To determine the effect of meal timing on neurovascular control in middle-aged adults.

Conditions: Blood Pressure, Neurovascular Control
Being tested: Time-Restricted Feeding
Keywords: Meal Timing, Blood Pressure, Time-Restricted Feeding, Sympathetic Nerve Activity
Medical subject headings: Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time-Restricted FeedingBehavioural
After baseline measurements have been completed, participants will enroll in a time-restricted feeding intervention. Participants will be asked to restrict the time in which they eat each day to 10 hours, fasting for the remaining 14 hours. Participants will also be asked to finish their last meal of the day at least 2 hours prior to bedtime.

Study groups in NCT04133701
Study group	Role	What they receive
Time-Restricted Feeding	Experimental	Control (Baseline): Blood pressure and neurovascular control will be measured. Post-Intervention: Blood pressure and neurovascular control will be measured. Receives: Behavioral: Time-Restricted Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Pressure measured continuously over a period of 24 hour
Utilize an ambulatory blood pressure monitor to measure blood pressure values continuously over a 24-hour period.
Measured: Continuously over a 24-hour period
Neurovascular Control: Change in the brain blood flow
Change in brain blood flow will be measured using a transcranial Doppler ultrasound in response to a breathing test.
Measured: Baseline and 5 weeks
Neurovascular Control: Change in the blood pressure
Change in blood pressure in response to a breathing test.
Measured: Baseline and 5 weeks
Neurovascular Control: change in the sympathetic nerve activity
Change in sympathetic nerve activity will be measured using microneurography in response to a breathing test.
Measured: Baseline and 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 202216 Dec 2022

First posted21 Oct 2019
Study start2 Feb 2022
Primary completion16 Dec 2022
Study completion16 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (49)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
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: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: The interventional study model used will consist of a time-restricted feeding intervention.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04133701
Sponsor's protocol ID: 2019-0417
Other IDs: A176000, EDUC/KINESIOLOGY/KINESIO, Protocol Version 5/4/2021
Status last verified: Mar 2023
First submitted: 16 Oct 2019
Last updated: 22 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ingelsson E, Bjorklund-Bodegard K, Lind L, Arnlov J, Sundstrom J. Diurnal blood pressure pattern and risk of congestive heart failure. JAMA. 2006 Jun 28;295(24):2859-66. doi: 10.1001/jama.295.24.2859.
PubMed 16804152
de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26.
PubMed 19171788
Loredo JS, Nelesen R, Ancoli-Israel S, Dimsdale JE. Sleep quality and blood pressure dipping in normal adults. Sleep. 2004 Sep 15;27(6):1097-103. doi: 10.1093/sleep/27.6.1097.
PubMed 15532203
Verdecchia P, Porcellati C, Schillaci G, Borgioni C, Ciucci A, Battistelli M, Guerrieri M, Gatteschi C, Zampi I, Santucci A, Santucci C, Reboldi G, et al. Ambulatory blood pressure. An independent predictor of prognosis in essential hypertension. Hypertension. 1994 Dec;24(6):793-801. doi: 10.1161/01.hyp.24.6.793.
PubMed 7995639
Verdecchia P, Schillaci G, Gatteschi C, Zampi I, Battistelli M, Bartoccini C, Porcellati C. Blunted nocturnal fall in blood pressure in hypertensive women with future cardiovascular morbid events. Circulation. 1993 Sep;88(3):986-92. doi: 10.1161/01.cir.88.3.986.
PubMed 8353926
Hajjar I, Selim M, Novak P, Novak V. The relationship between nighttime dipping in blood pressure and cerebral hemodynamics in nonstroke patients. J Clin Hypertens (Greenwich). 2007 Dec;9(12):929-36. doi: 10.1111/j.1524-6175.2007.07342.x.
PubMed 18046099
Grassi G, Seravalle G, Quarti-Trevano F, Dell'Oro R, Bombelli M, Cuspidi C, Facchetti R, Bolla G, Mancia G. Adrenergic, metabolic, and reflex abnormalities in reverse and extreme dipper hypertensives. Hypertension. 2008 Nov;52(5):925-31. doi: 10.1161/HYPERTENSIONAHA.108.116368. Epub 2008 Sep 8.
PubMed 18779438
Pearson TA, Blair SN, Daniels SR, Eckel RH, Fair JM, Fortmann SP, Franklin BA, Goldstein LB, Greenland P, Grundy SM, Hong Y, Miller NH, Lauer RM, Ockene IS, Sacco RL, Sallis JF Jr, Smith SC Jr, Stone NJ, Taubert KA. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Science Advisory and Coordinating Committee. Circulation. 2002 Jul 16;106(3):388-91. doi: 10.1161/01.cir.0000020190.45892.75. No abstract available.
PubMed 12119259
Douma LG, Gumz ML. Circadian clock-mediated regulation of blood pressure. Free Radic Biol Med. 2018 May 1;119:108-114. doi: 10.1016/j.freeradbiomed.2017.11.024. Epub 2017 Dec 2.
PubMed 29198725
Longo VD, Panda S. Fasting, Circadian Rhythms, and Time-Restricted Feeding in Healthy Lifespan. Cell Metab. 2016 Jun 14;23(6):1048-1059. doi: 10.1016/j.cmet.2016.06.001.
PubMed 27304506
Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
PubMed 27885007
Su WL, J. Guo, Z., and Gong, M.C. Time of Food Intake is an Important Determinant of Blood Pressure Circadian Rhythm. Hypertension. 2015;66:AP:225.
Nikolaeva S, Pradervand S, Centeno G, Zavadova V, Tokonami N, Maillard M, Bonny O, Firsov D. The circadian clock modulates renal sodium handling. J Am Soc Nephrol. 2012 Jun;23(6):1019-26. doi: 10.1681/ASN.2011080842. Epub 2012 Mar 22.
PubMed 22440902
Grassi G, Bombelli M, Seravalle G, Dell'Oro R, Quarti-Trevano F. Diurnal blood pressure variation and sympathetic activity. Hypertens Res. 2010 May;33(5):381-5. doi: 10.1038/hr.2010.26. Epub 2010 Mar 5.
PubMed 20203684
Fryar CD, Chen TC, Li X. Prevalence of uncontrolled risk factors for cardiovascular disease: United States, 1999-2010. NCHS Data Brief. 2012 Aug;(103):1-8.
PubMed 23101933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Meal Timing on Neurovascular Control in Adults
ClinicalTrials.gov ID: NCT04133701
Acronym / sponsor ID: 2019-0417
Conditions: Blood Pressure, Neurovascular Control
Keywords: Meal Timing, Blood Pressure, Time-Restricted Feeding, Sympathetic Nerve Activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: American Heart Association
Study start: 2 Feb 2022 (actual)
Primary completion: 16 Dec 2022 (actual)
Study completion: 16 Dec 2022 (actual)
First posted: 21 Oct 2019 (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.

Detailed description

The research aims are:

To determine the effect of meal timing on blood pressure patterns in middle-aged adults.
To determine the effect of meal timing on neurovascular control in middle-aged adults.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The interventional study model used will consist of a time-restricted feeding intervention.

Arm	Type	Receives
Time-Restricted Feeding	Experimental	Behavioral: Time-Restricted FeedingControl (Baseline): Blood pressure and neurovascular control will be measured. Post-Intervention: Blood pressure and neurovascular control will be measured.

Who may qualify

Ages: 50 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

BMI ≤ 34 kg/m2
Non-smoking
Sedentary or recreationally active
≤ 2 Alcoholic drinks per day
Female subjects: Perimenopausal/Postmenopausal

Key exclusion criteria (7 listed)

History or evidence of hepatic, renal, hematological, peripheral vascular disease, or stroke/neurovascular disease, diabetes, uncontrolled hypertension, sleep apnea
On medications used to treat/manage diseases listed above
Work overnight shifts
Clinically diagnosed anxiety or depression
Pregnant or trying to become pregnant

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
Time-Restricted FeedingAfter baseline measurements have been completed, participants will enroll in a time-restricted feeding intervention. Participants will be asked to restrict the time in which they eat each day to 10 hours, fasting for the remaining 14 hours. Participants will also be asked to finish their last meal of the day at least 2 hours prior to bedtime.	Behavioural	Time-Restricted Feeding

Primary outcome

Blood Pressure measured continuously over a period of 24 hour
Time frame: Continuously over a 24-hour period
Utilize an ambulatory blood pressure monitor to measure blood pressure values continuously over a 24-hour period.
Neurovascular Control: Change in the brain blood flow
Time frame: Baseline and 5 weeks
Change in brain blood flow will be measured using a transcranial Doppler ultrasound in response to a breathing test.
Neurovascular Control: Change in the blood pressure
Time frame: Baseline and 5 weeks
Change in blood pressure in response to a breathing test.
Neurovascular Control: change in the sympathetic nerve activity
Time frame: Baseline and 5 weeks
Change in sympathetic nerve activity will be measured using microneurography in response to a breathing test.

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 22 Mar 2023.
Background: PubMed 16804152Ingelsson E, Bjorklund-Bodegard K, Lind L, Arnlov J, Sundstrom J. Diurnal blood pressure pattern and risk of congestive heart failure. JAMA. 2006 Jun 28;295(24):2859-66. doi: 10.1001/jama.295.24.2859.
Background: PubMed 19171788de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26.
Background: PubMed 15532203Loredo JS, Nelesen R, Ancoli-Israel S, Dimsdale JE. Sleep quality and blood pressure dipping in normal adults. Sleep. 2004 Sep 15;27(6):1097-103. doi: 10.1093/sleep/27.6.1097.
Background: PubMed 7995639Verdecchia P, Porcellati C, Schillaci G, Borgioni C, Ciucci A, Battistelli M, Guerrieri M, Gatteschi C, Zampi I, Santucci A, Santucci C, Reboldi G, et al. Ambulatory blood pressure. An independent predictor of prognosis in essential hypertension. Hypertension. 1994 Dec;24(6):793-801. doi: 10.1161/01.hyp.24.6.793.
Background: PubMed 8353926Verdecchia P, Schillaci G, Gatteschi C, Zampi I, Battistelli M, Bartoccini C, Porcellati C. Blunted nocturnal fall in blood pressure in hypertensive women with future cardiovascular morbid events. Circulation. 1993 Sep;88(3):986-92. doi: 10.1161/01.cir.88.3.986.
Background: PubMed 18046099Hajjar I, Selim M, Novak P, Novak V. The relationship between nighttime dipping in blood pressure and cerebral hemodynamics in nonstroke patients. J Clin Hypertens (Greenwich). 2007 Dec;9(12):929-36. doi: 10.1111/j.1524-6175.2007.07342.x.
Background: PubMed 18779438Grassi G, Seravalle G, Quarti-Trevano F, Dell'Oro R, Bombelli M, Cuspidi C, Facchetti R, Bolla G, Mancia G. Adrenergic, metabolic, and reflex abnormalities in reverse and extreme dipper hypertensives. Hypertension. 2008 Nov;52(5):925-31. doi: 10.1161/HYPERTENSIONAHA.108.116368. Epub 2008 Sep 8.
Background: PubMed 12119259Pearson TA, Blair SN, Daniels SR, Eckel RH, Fair JM, Fortmann SP, Franklin BA, Goldstein LB, Greenland P, Grundy SM, Hong Y, Miller NH, Lauer RM, Ockene IS, Sacco RL, Sallis JF Jr, Smith SC Jr, Stone NJ, Taubert KA. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patients Without Coronary or Other Atherosclerotic Vascular Diseases. American Heart Association Science Advisory and Coordinating Committee. Circulation. 2002 Jul 16;106(3):388-91. doi: 10.1161/01.cir.0000020190.45892.75. No abstract available.
Background: PubMed 29198725Douma LG, Gumz ML. Circadian clock-mediated regulation of blood pressure. Free Radic Biol Med. 2018 May 1;119:108-114. doi: 10.1016/j.freeradbiomed.2017.11.024. Epub 2017 Dec 2.
Background: PubMed 27304506Longo VD, Panda S. Fasting, Circadian Rhythms, and Time-Restricted Feeding in Healthy Lifespan. Cell Metab. 2016 Jun 14;23(6):1048-1059. doi: 10.1016/j.cmet.2016.06.001.
Background: PubMed 27885007Panda S. Circadian physiology of metabolism. Science. 2016 Nov 25;354(6315):1008-1015. doi: 10.1126/science.aah4967.
BackgroundSu WL, J. Guo, Z., and Gong, M.C. Time of Food Intake is an Important Determinant of Blood Pressure Circadian Rhythm. Hypertension. 2015;66:AP:225.
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.

Jill N Barnes, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Time-Restricted Feeding in people with Blood Pressure and Neurovascular Control, run by University of Wisconsin, Madison 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 5 inclusion and 7 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 22 Mar 2023. 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?

Blood Pressure measured continuously over a period of 24 hour (time frame: Continuously over a 24-hour period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133701, which also lists 49 linked publications.

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 22 Mar 2023.