ImpaCt Of Shiftwork on METabolic Flexibility and Skeletal Muscle Clocks

Completed

Conditions studied: Metabolic Health

In brief

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

Key facts

Study ID: NCT05820490
Run by: AdventHealth Translational Research Institute
People needed: 40
Starts: 2023-07-28
Expected to finish: 2026-01-31
Last updated by the study team: 2026-04-15

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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)
Liver disease (liver function tests > 2 x normal; including nonalcoholic steatohepatitis [NASH] and non-alcoholic fatty liver disease [NAFLD])
Diagnosed or being treated for sleep disorders
History of Cushing's disease or syndrome
Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection
Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women) during screening
Participation in studies involving investigational drug(s) within 30 days prior to Screening
Gastrointestinal disorders (including inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis)
Past or present history of psychiatric disease, including major depressive illness or bipolar disorder, as well as claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry
Unwilling or unable to eat foods provided in study procedures
Nickel allergy
Lidocaine allergy
Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years)
Use of antibiotics within 3 months of screening
Illicit drug use (negative tests at screening)
Regular smoking or regular nicotine use of any kind including chewing tobacco, snuff and vaping

Where it is running

AdventHealth Translational Research Institute — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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