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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 : November 1, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Neurovascular Control Behavioral: Time-Restricted Feeding Not Applicable

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.

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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 : December 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Neurovascular Control: Change in the blood pressure [ Time Frame: Baseline and 5 weeks ]
    Change in blood pressure in response to a breathing test.

  4. 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.



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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≤ 34 kg/m2
  • Non-smoking
  • Sedentary or recreationally active
  • ≤ 2 Alcoholic drinks per day
  • Female subjects: 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
  • Significant surgical history
  • Other significant medical conditions at investigator's discretion

Information from the National Library of Medicine

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


Contacts
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Contact: Jill N Barnes, PhD 608-262-1654 jnbarnes@wisc.edu
Contact: Andrew G Pearson, MS 608-262-9572 barneslab@education.wisc.edu

Sponsors and Collaborators
University of Wisconsin, Madison
American Heart Association
Investigators
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Principal Investigator: Jill N Barnes, PhD University of Wisconsin, Madison

Publications:
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.
Prevention CfDCa. Vital Signs. 2018.

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04133701     History of Changes
Other Study ID Numbers: 2019-0417
A176000 ( Other Identifier: UW, Madison )
EDUC/KINESIOLOGY/KINESIO ( Other Identifier: UW, Madison )
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Meal Timing
Blood Pressure
Time-Restricted Feeding
Sympathetic Nerve Activity