Meal Timing and Blood Pressure

NCT04133701 | Completed

• 4 other identifiers: 2019-0417A176000EDUC/KINESIOLOGY/KINESIOProtocol Version 5/4/2021
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Neurovascular Control

Keywords

Meal Timing; Blood Pressure; Time-Restricted Feeding; Sympathetic Nerve Activity

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Neurovascular Control: Change in the blood pressure

  Change in blood pressure in response to a breathing test.

  Baseline and 5 weeks

• 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

Study Arms (1)

Time-Restricted Feeding

EXPERIMENTAL

Control (Baseline): Blood pressure and neurovascular control will be measured. Post-Intervention: Blood pressure and neurovascular control will be measured.

Behavioral: Time-Restricted Feeding

Interventions

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.

Time-Restricted Feeding

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≤ 34 kg/m2
• Non-smoking
• Sedentary or recreationally active
• ≤ 2 Alcoholic drinks per day
• Female subjects: Perimenopausal/Postmenopausal

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• American Heart Association: collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location

Related Publications (49)

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MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Officials

• Jill N Barnes, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The interventional study model used will consist of a time-restricted feeding intervention.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 21, 2019
• Study Start: February 2, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)