Aerobic Exercise as a Countermeasure for Night Shift Associated Circadian Misalignment

NCT07668622 | Not Yet Recruiting

• 1 other identifier: 26-0127
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to learn more about whether exercise can help protect the body from health problems that happen when a person's sleep and daily schedule are out of sync with their natural body clock (circadian rhythm).

Conditions

Healthy; Circadian Misalignment

Outcome Measures

Primary Outcomes (2)

• 24-hour ambulatory BP

  : During your WRIC visits on day 2 and day 5, a blood pressure cuff will be placed on your non-dominant arm to measure blood pressure every 30 minutes during the day and every 60 minutes at night.

  Days 2 and 5

• Mixed Meal Tolerance Test

  On days 2 and 5, approximately 1 hour after waking up, you will have your blood drawn via an IV in your arm and will be given a liquid shake to consume. Over the course of 2 hours, regular, frequent blood samples will be collected through the IV over the duration of this test.

  Days 2 and 5

Study Arms (2)

Control

NO INTERVENTION

Participants in this arm will engage in simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with day time sleep.

Exercise

EXPERIMENTAL

Participants in this arm will engage in simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with day time sleep. In addition, participants will engage in a 45-minute bout of moderate intensity exercise at 2.5 hours after waking on days 3, 4, and 5.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Participants will engage in a 5-day stay that includes simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with daytime sleep. On days 1, 3, and 4, participants will be provided food to eat (Day 1 +/- 1 hour:\~18:00 and \~23:00, Day 3 +/- 1 hour: \~08:30, \~13:00, \~18:00, \~23:00, and \~04:00. Day 4 +/-1 hour: \~18:00, \~23:00, \~04:00, and \~07:00). On days 2 and 5, participants will be provided with a diet to maintain your current weight (30% breakfast, 30% lunch, 30% dinner, 10% snack). On Day 2, participants will be provided a diet to be consumed at the following times: breakfast 08:30, lunch 13:00, dinner 18:00, snack 23:00. On Day 5, participants will follow a night shift schedule and meal timing that will follow the following schedule: breakfast 18:00, lunch 23:00, dinner 04:00, snack 07:00. Participants will engage in a 45-minute bout of moderate intensity aerobic exercise at 2.5 h after waking on days 3, 4, and 5.

Exercise

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-40 years
• Body Mass Index 18.5-\<40kg/m\^2
• Physically inactive: defined as \<150 minutes per week of voluntary exercise at moderate intensity or greater and \<60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months.
• No plans to relocate within the next 6 months.
• No plans for extended travel (\>2 weeks) within the next 3 months.

You may not qualify if:

• Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures.
• No contraindications to exercise or limitations on ability to be physically active.
• Ability to adhere to sleeping, eating, and exercise protocol
• Willing and able to wear activity/sleep monitor for 7 consecutive days.
• For Females:
• Not currently pregnant or lactating.
• Not pregnant within the past 6 months.
• Not planning to become pregnant in the next 6 months
• Regularly timed menstrual cycles to facilitate measurement of EE in the early follicular phase.
• Diastolic blood pressure \>100 mmHG, systolic blood pressure \>160 mmHG, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position.
• Diabetes (fasting glucose \>/=126 mg/dL or Hemoglobin A1C \>/=6.5%) as measured during the screening visit.
• Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
• Triglycerides \>400 mg/dL as measured on the screening visit.
• LDL cholesterol \>200 mg/dL as measured on the screening visit.
• Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Seth Creasy, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Lorentzen, BHS

CONTACT

303-724-3685; justin.lorentzen@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)