Healthy Night Shift WorkersNCT01767181
Light and Exercise in Night-shift Workers
A study testing Intensive light therapy and Exercise in people with Healthy Night Shift Workers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Night Shift Workers
- What is being tested?
- Intensive light therapy and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Timed Intensive Light Therapy or Timed Physical Exercise on Markers of Central and Peripheral Circadian Rhythm and on Cardiometabolic Function in Night Shift Workers
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.
Read the 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.
- Conditions
- Healthy Night Shift Workers
- Being tested
- Intensive light therapy, Exercise
- Keywords
- Light therapy, physical exercise, night shift workers, genetic markers, PBMCs
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive light therapyOther
Light therapy will be applied by a Lumie Brazil fluorescent tube light box (10.000 lux) during the night shifts for 12 consecutive weeks
ExerciseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Control group without intervention |
| B | Experimental | Intensive light therapy during the first half of the night shift Receives: Other: Intensive light therapy |
| C | Experimental | Exercise before the beginning of the night shift Receives: Other: Exercise |
| D | Experimental | Exercise after the end of the night shift Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
The difference of the expression pattern of the CLOCK gene in peripheral blood mononuclear cells (PBMCs) after 12 weeks between intervention and control group
Measured: 12 weeks
Secondary outcomes (7)
Efficacy
The changes in body weight, BMI, abdominal circumference from baseline to 12 weeks of intervention
Measured: 12 weeks
Efficacy
The differences in the circadian expression pattern of genes involved in circadian rhythm (e.g., Cryptochrome 1, Bmal 1, RORα, Rev-erbα, Period 1, Period 3, Timeless, Adam 17, PPAR-α, PPAR-γ, Klotho, DDAH-1, DDAH-2, AGXT 2, AGAT, VDR, TIMP 3) in peripheral blood mononuclear cells (PBMCs) after 12 weeks between intervention and control group
Measured: 12 weeks
Efficacy
The differences in the expression of genes involved in circadian rhythm (e.g. Cryptochrome 1, Clock, Bmal 1, RORα, Rev-erbα, Period 1, Period 3, Timeless, Adam 17, PPAR-α, PPAR-γ, Klotho, DDAH-1, DDAH-2, AGXT 2, AGAT, VDR, TIMP 3) in adipose tissue and muscle tissue, between baseline and 12 weeks of intervention (restricted to participants who consent to this part of the study
Measured: 12 weeks
Efficacy
The reversibility of the differences in the expression profiles of genes involved in circadian rhythm in peripheral blood mononuclear cells (PBMCs) 12 weeks after the end of the intervention period (=week 24 of the study)
Measured: 12 weeks
Efficacy
The differences in epigenetic profiles of genes involved in circadian rhythm between baseline and 12 weeks of intervention
Measured: 12 weeks
Efficacy
The reversibility of the differences in the biochemical markers and indices of cardiometabolic function (e.g. fasting glucose, fasting insulin, HOMA, OGTT, QUICKI index, Stumvoll-ISI index, HbA1c, ADMA, SDMA, fibrinogen, PAI-1, triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol, C-reactive protein, C3, systolic and diastolic blood pressure, endothelial function, IMT) 12 weeks after the end of the intervention period (=week 24 of the study)
Measured: 12 weeks
Efficacy
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Night Shift WorkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Böger, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767181
- Sponsor's protocol ID
- EuRhythDia-1
- Status last verified
- Aug 2017
- First submitted
- 10 Jan 2013
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Timed Intensive Light Therapy or Timed Physical Exercise on Markers of Central and Peripheral Circadian Rhythm and on Cardiometabolic Function in Night Shift Workers
- ClinicalTrials.gov ID
- NCT01767181
- Acronym / sponsor ID
- EuRhythDia-1
- Conditions
- Healthy Night Shift Workers
- Keywords
- Light therapy, physical exercise, night shift workers, genetic markers, PBMCs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Control group without intervention |
| B | Experimental | Other: Intensive light therapyIntensive light therapy during the first half of the night shift |
| C | Experimental | Other: ExerciseExercise before the beginning of the night shift |
| D | Experimental | Other: ExerciseExercise after the end of the night shift |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive light therapyLight therapy will be applied by a Lumie Brazil fluorescent tube light box (10.000 lux) during the night shifts for 12 consecutive weeks | Other | B |
| ExercisePhysical 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) | Other | C, D |
Primary outcome
Efficacy
Time frame: 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
7 secondary outcomes
Efficacy
Time frame: 12 weeks
Efficacy
Time frame: 12 weeks
Efficacy
Time frame: 12 weeks
Efficacy
Time frame: 12 weeks
Efficacy
Time frame: 12 weeks
Efficacy
Time frame: 12 weeks
Efficacy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy Night Shift Workers
Not yet recruiting
Effects of a Sleep Education Program on the Health Status of Healthcare Workers Working 12-hour Alternating Day-night Shifts
Healthy Volunteers (HV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Böger, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive light therapy and Exercise in people with Healthy Night Shift Workers, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.