Light and Exercise in Night-shift Workers

Not Applicable

Completed

• Conditions: Healthy Night Shift Workers
• Interventions: Other: Intensive light therapy; Other: Exercise

• Registration Number: NCT01767181
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-14
• Study Start: 2013-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Intensive light therapy	Intensive light therapy during the first half of the night shift
C	Exercise	Exercise before the beginning of the night shift
D	Exercise	Exercise after the end of the night shift

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Efficacy	12 weeks	The differences in metabolomic profiling between baseline, 12 weeks of intervention, and after 12 weeks of wash-out (Plasma samples will be collected for metabolomic analysis at these time points)

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany