Meal Timing and Blood Pressure

Not Applicable

Completed

• Conditions: Blood Pressure; Neurovascular Control
• Interventions: Behavioral: Time-Restricted Feeding

• Registration Number: NCT04133701
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Study Start: 2022-02-02
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Time-Restricted Feeding	Time-Restricted Feeding	Control (Baseline): Blood pressure and neurovascular control will be measured. Post-Intervention: Blood pressure and neurovascular control will be measured.

Primary Outcome Measures

Name	Time	Method
Blood Pressure measured continuously over a period of 24 hour	Continuously over a 24-hour period	Utilize an ambulatory blood pressure monitor to measure blood pressure values continuously over a 24-hour period.
Neurovascular Control: Change in the brain blood flow	Baseline and 5 weeks	Change in brain blood flow will be measured using a transcranial Doppler ultrasound in response to a breathing test.
Neurovascular Control: Change in the blood pressure	Baseline and 5 weeks	Change in blood pressure in response to a breathing test.
Neurovascular Control: change in the sympathetic nerve activity	Baseline and 5 weeks	Change in sympathetic nerve activity will be measured using microneurography in response to a breathing test.

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States