Healthy Night Shift Workers
Conditions
Keywords
Light therapy, physical exercise, night shift workers, genetic markers, PBMCs
Brief summary
EuRhythDia is a multicenter, controlled and randomized study. The aim of the study is to investigate the effects of 12 weeks of randomized timed light therapy or timed physical exercise as a chronotherapeutic lifestyle intervention on markers of central and peripheral circadian rhythms and cardiometabolic function in healthy night shift workers.
Detailed description
Lifestyle interventions have been recognized as important means to prevent and treat cardiometabolic disease. However, compliance of the European population to general recommendations of exercise and weight loss is unsatisfactory. There have been no studies that have attempted to convert the exciting new experimental data on the circadian clock, lifestyle, and cardiometabolic risk into diagnostic tools or novel therapeutic approaches via structured multidisciplinary efforts. One of the aims of the EuRhytDia study is to study novel applications of established lifestyle interventions by co-ordinating the timing of interventions with circadian rhythmicity.
Interventions
OTHERIntensive light therapy
Light therapy will be applied by a Lumie Brazil fluorescent tube light box (10.000 lux) during the night shifts for 12 consecutive weeks
OTHERExercise
Physical exercise will be performed in a supervised environment on the days of the night shifts, either before the start of the shift (defined as a time period beginning no earlier than 2 hours before the start of the shift) or after the end of the night shift (defined as a time period ending no longer than 2 hours after the end of the night shift)
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects above the age of 18 * Night shift workers on regular night shifts with at least 3 nights in a row per month during the study period * Subjects must have been on night shifts for at least 4 weeks before inclusion into the study * Signed written informed consent
Exclusion criteria
* Regular use of drugs (prescription or non-prescription, exception: contraceptives) or dietary supplements within 4 weeks before inclusion of the study * Pregnancy or breast feeding * Any severe somatic or psychic disease (malignant or non-malignant * Any known ophthalmological condition that prevents the exposure to bright light (e.g. cataract, glaucoma, retinopathy, macular degeneration, acute eye infections, lesions of the cornea) * Any skin condition or use of drugs associated with increased photosensitivity; * Any kind of disability that would prevent the subjects from participation in exercise training sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 12 weeks | The difference of the expression pattern of the CLOCK gene in peripheral blood mononuclear cells (PBMCs) after 12 weeks between intervention and control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 12 weeks | The changes in body weight, BMI, abdominal circumference from baseline to 12 weeks of intervention |
Countries
Germany
Outcome results
None listed