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Biomarker based intervention strategies to combat adverse effects of shift work

Biomarker based intervention strategies to combat adverse effects of shift work - GRIP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53661
Enrollment
75
Registered
2023-01-17
Start date
2023-02-09
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

slaap, vermoeidheid, wellbevinden metabolic health sleep

Interventions

Participants in the sleep intervention receive advice on: sleep hygiene/environment, sleep timing, naps, and exposure to light. These advices will be tailored to the personal situation of the partic

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

MeasureTime frame
The primary outcomes are the quality and quantity of sleep and stability and levels of (continuous) glucose patterns.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)