Clinical Trials/NCT05820490

NCT05820490

Completed

Not Applicable

ImpaCt Of Shiftwork on METabolic Flexibility and Skeletal Muscle Clocks

AdventHealth Translational Research Institute2 sites in 1 country40 target enrollmentJuly 28, 2023

InterventionsWhole Room Calorimeter Mixed-Meal Tolerance Test (MMTT)Core Body Temperature Morningness-Eveningness Questionnaire Muscle Biopsy Serial Blood Sampling

Overview

Phase: Not Applicable
Intervention: Whole Room Calorimeter
Conditions: Metabolic Health
Sponsor: AdventHealth Translational Research Institute
Enrollment: 40
Locations: 2
Primary Endpoint: Metabolic flexibility, or substrate switching capacity, will differ between dayshift and nightshift workers.
Status: Completed
Last Updated: 17 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the impact of real-world shiftwork on metabolic flexibility.

Registry

clinicaltrials.gov

Start Date

July 28, 2023

End Date

January 31, 2026

Last Updated

17 days ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AdventHealth Translational Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 21-45 yrs
•Employed as a healthcare worker in either dayshift (N=15) or nightshift work (N=30).
•Nightshift is defined as 12 months of consecutive nightshift work, who had 10 or more nightshifts per month (6 h between 10 PM and 8 AM, with no shift duration \> 12 h).
•Dayshift is defined as 12 months of consecutive dayshift work, who had 10 or more dayshifts per month (6h between 8 AM and 10 PM, with no shift duration \> 12 h).
•Weight Stable (+/- 3 kg over past 6 months)
•BMI between 18.5-29.9 kg/m2
•Understands the procedures and agrees to participate by giving written informed consent
•Willing and able to comply with scheduled visits, laboratory tests, and other study procedures including
•Only low to moderate caffeine users (\<500 mg/day, or up to approximately 5 cups \[1 cup=8 ounces\] of coffee/day.

Exclusion Criteria

•Acute or chronic medical conditions or medication that would contraindicate participation in the research testing or could potentially affect metabolic function including, but not limited to:
•History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator)
•Type 1 or Type 2 diabetes mellitus
•Obesity (BMI ≥ 30 kg/m2)
•Bleeding and clotting disorders
•Uncontrolled hypertension (BP \>160 mmHg systolic or \>100 mmHg diastolic)
•Acute or chronic infections (such as TB, HIV, or Hepatitis)
•Renal insufficiency or nephritis (eGFR\<60), nephritis, or chronic kidney disease
•Chronic obstructive pulmonary disease
•Thyroid dysfunction (suppressed TSH, elevated TSH \<10 µIU/ml if symptomatic or elevated TSH \>10 µIU/ml if asymptomatic)

Arms & Interventions

Dayshift workers

Intervention: Whole Room Calorimeter

Dayshift workers

Intervention: Mixed-Meal Tolerance Test (MMTT)

Dayshift workers

Intervention: Core Body Temperature

Dayshift workers

Intervention: Morningness-Eveningness Questionnaire

Dayshift workers

Intervention: Muscle Biopsy

Dayshift workers

Intervention: Serial Blood Sampling

Nightshift workers

Intervention: Whole Room Calorimeter

Nightshift workers

Intervention: Mixed-Meal Tolerance Test (MMTT)

Nightshift workers

Intervention: Core Body Temperature

Nightshift workers

Intervention: Morningness-Eveningness Questionnaire

Nightshift workers

Intervention: Muscle Biopsy

Nightshift workers

Intervention: Serial Blood Sampling

Outcomes

Primary Outcomes

Metabolic flexibility, or substrate switching capacity, will differ between dayshift and nightshift workers.

Time Frame: 30 days, including a two night stay

Rates (change over time) of substrate oxidation will be assessed via whole-room indirect calorimetry during a 24h protocol that includes controlled meals and sleep.