RECRUITING

ImpaCt Of Shiftwork on METabolic Flexibility and Skeletal Muscle Clocks

Conditions

Metabolic Health metabolic flexibility skeletal muscle circadian clock fatty acid oxidation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

ImpaCt Of Shiftwork on METabolic Flexibility and Skeletal Muscle Clocks

Quick Facts

Study Start:2023-07-28

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05820490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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 * History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening. * Excessive caffeine use (\>500 mg/day, or exceeding 5 cups \[1 cup= 8 ounces\] of coffee/day) * Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening (participants may not donate blood any time during the study, through the final study day) * Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days. * More than 1-day a week of intentional exercise * Any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) * Medications that strongly impact bleeding, clotting, bruising, or platelets (e.g. blood thinner prescription medications) * Recent change to medication and/or dosing in the past 3 months * Chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors

Inclusion Criteria

Exclusion 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.

* 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
* History of regular alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male participants (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening.
* Excessive caffeine use (\>500 mg/day, or exceeding 5 cups \[1 cup= 8 ounces\] of coffee/day)
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening (participants may not donate blood any time during the study, through the final study day)
* Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days.
* More than 1-day a week of intentional exercise
* Any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
* Medications that strongly impact bleeding, clotting, bruising, or platelets (e.g. blood thinner prescription medications)
* Recent change to medication and/or dosing in the past 3 months
* Chronic use of aspirin or other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors

Contacts and Locations

Study Contact

Recruitment Department

CONTACT

407-303-7100

Fh.tri.recruitment@adventhealth.com

Principal Investigator

Melissa Erickson, PhD

PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Study Locations (Sites)

AdventHealth Translational Research Institute

Orlando, Florida, 32804

United States

Collaborators and Investigators

Sponsor: AdventHealth Translational Research Institute

Melissa Erickson, PhD, PRINCIPAL_INVESTIGATOR, Study Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-28

Study Completion Date2026-03

Study Record Updates

Study Start Date2023-07-28

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

metabolic flexibility
skeletal muscle circadian clock
fatty acid oxidation

Additional Relevant MeSH Terms

Metabolic Health