Meal Timing and Blood Pressure

March 21, 2023 updated by: University of Wisconsin, Madison

The Impact of Meal Timing on Neurovascular Control in Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Baseline and 5 weeks
Neurovascular Control: Change in the blood pressure
Time Frame: Baseline and 5 weeks
Change in blood pressure in response to a breathing test.
Baseline and 5 weeks
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.
Baseline and 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

American Heart Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Actual)

December 16, 2022

Study Completion (Actual)

December 16, 2022

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

October 17, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-0417
  • A176000 (Other Identifier: UW Madison)
  • EDUC/KINESIOLOGY/KINESIO (Other Identifier: UW Madison)
  • Protocol Version 5/4/2021 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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