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OpenTrials
Completed

NCT Number: NCT04133701

Meal Timing and Blood Pressure

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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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-restricted feeding

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • American Heart Association

Registry information

Official study title

The Impact of Meal Timing on Neurovascular Control in Adults

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2019
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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