Overweight, Obesity Grade ILEXI-MONCT02636335
Light, Exercise Intensity and Mood in Overweight
A study testing Phillips Energy Light HF3319 in people with Overweight, Obesity Grade I, run by University of Basel at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity Grade I
- What is being tested?
- Phillips Energy Light HF3319
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2016to Jun 2017
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index 25 - 35 kg/m2
Who cannot join
- Women who are pregnant or breast feeding,
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Participation in other studies in the last four weeks
- Systolic blood pressure > 170 mmHg, diastolic blood pressure > 100 mmHg
Show all 11Show fewer
- Shift work in the last two months
- Travels across time zones in the last four weeks
- Use of photosensitisation drugs
- Clinical manifest depression
- Cardiovascular diseases which reduce age-appropriate exercise capacity
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients.
- Conditions
- Overweight, Obesity Grade I
- Being tested
- Phillips Energy Light HF3319
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phillips Energy Light HF3319Device
Exposure to Light administered with Phillips Energy Light HF3319.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light | Experimental | 8 a.m. study participants will be exposed to Bright Light (4500 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer.
The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart. Receives: Device: Phillips Energy Light HF3319 |
| Control | Experimental | 8 a.m. study participants will be exposed to a Control Light Condition (230 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer.
The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart. Receives: Device: Phillips Energy Light HF3319 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean power output in watts
Measured: Power output during the first 30 minute time-trial on a bicycle ergometer.
Secondary outcomes (3)
Subjective sleepiness
Subjective sleepiness will be measured with the Multidimensional Mood Questionnaire (Category "Wakefulness - Sleepiness")
Measured: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
Subjective Mood
Subjective Mood measured with the Multidimensional Mood Questionnaire (Category "Good Mood - Bad Mood")
Measured: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.
Measured: Mean of the 30 minutes of the exercise from the first, second and third time-trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, Obesity Grade IStudies 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
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arno Schmidt-Trucksäss, University of Basel
- Investigators
- Arno Schmidt-Trucksäss, Prof., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636335
- Sponsor's protocol ID
- LEXI-MO
- Acronym
- LEXI-MO
- Status last verified
- Jun 2017
- First submitted
- 14 Dec 2015
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light, Exercise Intensity and Mood in Overweight
- ClinicalTrials.gov ID
- NCT02636335
- Acronym / sponsor ID
- LEXI-MO / LEXI-MO
- Conditions
- Overweight, Obesity Grade I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Dec 2015 (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.
The purpose of this study is to determine if an exposure to light in the morning has a positive influence on self-chosen exercise intensity on a bicycle ergometer in overweight and obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light | Experimental | Device: Phillips Energy Light HF33198 a.m. study participants will be exposed to Bright Light (4500 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer. The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart. |
| Control | Experimental | Device: Phillips Energy Light HF33198 a.m. study participants will be exposed to a Control Light Condition (230 lx) Phillips Energy Light HF3319 for 30 minutes prior and during a 30 minute lasting exercise test with self-chosen exercise intensity on a bicycle ergometer. The light exposure and time-trial will be performed in three repetitive exercise sessions 48h apart. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body Mass Index 25 - 35 kg/m2
Key exclusion criteria (11 listed)
- Women who are pregnant or breast feeding,
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Previous enrolment into the current study
- Participation in other studies in the last four weeks
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 |
|---|---|---|
| Phillips Energy Light HF3319Exposure to Light administered with Phillips Energy Light HF3319. | Device | Bright Light, Control |
Primary outcome
Mean power output in watts
Time frame: Power output during the first 30 minute time-trial on a bicycle ergometer.
3 secondary outcomes
Subjective sleepiness
Time frame: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
Subjective Mood
Time frame: 1 minute after the light exposure vs. 1 minute before the light exposure in the first time trial
Mean power output in watts during the first, second and third time-trial on a bicycle ergometer.
Time frame: Mean of the 30 minutes of the exercise from the first, second and third time-trial.
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 29 Jun 2017.
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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.
Arno Schmidt-Trucksäss, Prof. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phillips Energy Light HF3319 in people with Overweight, Obesity Grade I, run by University of Basel at 1 site in Switzerland.
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 1 inclusion and 11 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 29 Jun 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 Switzerland. 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?
Mean power output in watts (time frame: Power output during the first 30 minute time-trial on a bicycle ergometer.). 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 29 Jun 2017; AzTrials last refreshed its copy on 2 Nov 2026.