Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
34 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-02-02
Study Completion Date
2022-12-16
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Blood Pressure
Neurovascular Control
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
The interventional study model used will consist of a time-restricted feeding intervention.
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Time-Restricted Feeding
Control (Baseline): Blood pressure and neurovascular control will be measured.
Post-Intervention: Blood pressure and neurovascular control will be measured.
Group Type
EXPERIMENTAL
Time-Restricted Feeding
Intervention Type
BEHAVIORAL
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* BMI ≤ 34 kg/m2
* Non-smoking
* Sedentary or recreationally active
* ≤ 2 Alcoholic drinks per day
* Female subjects: Perimenopausal/Postmenopausal
* 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
* 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
Minimum Eligible Age
50 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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American Heart Association
OTHER
Sponsor Role
collaborator
University of Wisconsin, Madison
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jill N Barnes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin-Madison
Madison, Wisconsin, United States
Site Status
Countries
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United States
References
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Other Identifiers
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A176000
Identifier Type: OTHER
Identifier Source: secondary_id
EDUC/KINESIOLOGY/KINESIO
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 5/4/2021
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0417
Identifier Type: -
Identifier Source: org_study_id
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