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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04133701
Other study ID # 2019-0417
Secondary ID A176000EDUC/KINE
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2022
Est. completion date December 16, 2022

Study information

Verified date March 2023
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 16, 2022
Est. primary completion date December 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Wisconsin-Madison Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (49)

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* Note: There are 49 references in allClick here to view all references

Outcome

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