Clinical trial NCT04133701: Meal Timing and Blood Pressure
Official title: The Impact of Meal Timing on Neurovascular Control in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Neurovascular Control
Keywords: Meal Timing
Blood Pressure
Time-Restricted Feeding
Sympathetic Nerve Activity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2019-10-21
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The interventional study model used will consist of a time-restricted feeding intervention.
Primary purpose: BASIC_SCIENCE

Brief 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.

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:

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood Pressure measured continuously over a period of 24 hour
timeFrame: Continuously over a 24-hour period
measure: Neurovascular Control: Change in the brain blood flow
timeFrame: Baseline and 5 weeks
measure: Neurovascular Control: Change in the blood pressure
timeFrame: Baseline and 5 weeks
measure: Neurovascular Control: change in the sympathetic nerve activity
timeFrame: Baseline and 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jill N Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
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