Meal Timing and Blood Pressure
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|ClinicalTrials.gov Identifier: NCT04133701|
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Neurovascular Control||Behavioral: Time-Restricted Feeding||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The interventional study model used will consist of a time-restricted feeding intervention.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Impact of Meal Timing on Neurovascular Control in Adults|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Time-Restricted Feeding
Control (Baseline): Blood pressure and neurovascular control will be measured.
Post-Intervention: Blood pressure and neurovascular control will be measured.
Behavioral: Time-Restricted Feeding
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133701
|Contact: Jill N Barnes, PhDemail@example.com|
|Contact: Andrew G Pearson, MSfirstname.lastname@example.org|
|Principal Investigator:||Jill N Barnes, PhD||University of Wisconsin, Madison|