Biomarker based intervention strategies to combat adverse effects of shift work

• Conditions: slaap, vermoeidheid, wellbevinden; metabolic health; sleep; 10003018; 10040991

• Registration Number: NL-OMON53661
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

• Age 18 to 60 years.
• Work at least 4 night shifts a month on average.
• Shift workers, working rotating shifts (morning, evening and night shifts) or
working predominantly night shifts. Night shift defined as work at least 1
hours between 0:00- and 6:00.
• Work at least 2 night shifts in a row
• Work >= 20 work hours per week.
• Having a shift duration of 6 h-12 h.
• History of >= 1 year of working rotating shift work or night shifts prior to
the study.

Exclusion Criteria

• Taking medication that the investigator believes would interfere with the
objectives of the study. For example, sleep medication, medication that
interferes with glucose homeostasis, and/or anti-inflammatory drugs.
• Pregnant or have a wish to become pregnant during the study period.
• Planned surgery during the entire study period
• Alcohol consumption > 21 units/week
• Severe psychiatric disease and/or any mental or physical disability that will
hinder participation in the interventions
• Severe cardiovascular disease, to the discretion of the study doctor
• Having a chronic inflammatory disease, including asthma, rheumatic fever,
IBD, COPD
• Other bowel diseases, including Chron*s disease and Colitis Ulcerosa.
• A disease or condition with higher bleeding risk (/risk of hemorrhage), under
which a blood sample may lead to complications.
• Participation in any clinical trial including blood sampling and/or
administration of substances up to 90 days before Day 01 of this study
• Recent blood donation (<1 month prior to the start of the study)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcomes are the quality and quantity of sleep and stability and<br /><br>levels of (continuous) glucose patterns. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include a set of relevant clinical biomarkers (of metabolic<br /><br>health, epigenetic DNA methylation profiles in blood, and stress markers in<br /><br>hair, and anthropometrics), and alertness during night shifts. For the<br /><br>nutritional intervention, metabolic flexibility and inflammatory resilience<br /><br>will be measured with the PhenFlex test. </p><br>