Circadian DysregulationNCT02291952
Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
A study testing Meal schedule in people with Circadian Dysregulation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Dysregulation
- What is being tested?
- Meal schedule
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2015to 29 Aug 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.5 and 29.9 kgm-2
- Healthy adults with regular sleep-wake timing
- Non-smokers
- Completion of medical and psychological screening tests
- Able to spend 14 consecutive days in the sleep laboratory
Who cannot join
- BMI <18.5 or > 29.9 kgm-2
- History of neurological or psychiatric disorder
- History of sleep disorder or regular use of sleep-promoting medication
- Current prescription, herbal, or over-the-counter medication use
- Traveling across 2 or more time zones within past 3 months
- Donating blood within past 8 weeks
Show all 9Show fewer
- Worked night or rotating shift work within past 3 years
- Hearing impairment
- Drug or alcohol dependency
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.
Read the detailed description
Shift work is associated with circadian misalignment and an increased risk for the development diabetes, obesity, and cardiovascular disease. This research will determine whether changing the feeding schedule can prevent metabolic alterations that can lead to the abovementioned disorders. This research will provide mechanistic insight and may provide a novel therapeutic approach against the increased risk for diabetes, obesity, and cardiovascular disease among shift workers.
- Conditions
- Circadian Dysregulation
- Being tested
- Meal schedule
- Keywords
- Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian
- Medical subject headings
- Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal scheduleBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | During Forced Desynchrony sleep and wake will occur at different circadian phases, while meals are restricted to the biological day. Receives: Behavioral: Meal schedule |
| Control | Other | During Forced Desynchrony sleep and wake, as well as meals, will occur at different circadian phases. Receives: Behavioral: Meal schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma leptin levels across sleep/wake cycle
Frequent blood samples
Measured: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Change in circadian profile of plasma leptin
Frequent blood samples
Measured: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Change in glucose tolerance
Frequent blood samples before and after standardized meals
Measured: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Change in circadian profile of plasma glucose levels
Frequent blood samples
Measured: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Change in plasma insulin levels after standardized test meal
Frequent blood samples before and after standardized meals
Measured: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Change in circadian profile of plasma insulin levels
Frequent blood samples
Measured: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Secondary outcomes (5)
o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol
Core temperature sensor throughout protocol, days 1-14. Frequent blood samples during constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Measured: Core temperature and frequent blood samples
Changes circadian rhythm in resting energy expenditure
Indirect calorimetry
Measured: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Change in hunger and appetite, mood, and cognitive performance
Subjective hunger ratings and cognitive tests performed via computer interface
Measured: Tests taken throughout the protocol, days 1-14
Changes in microbiota, gene expression, epigenetic or proteomic markers
Frequent blood samples and saliva samples
Measured: samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13)
Changes in sleep
Polysomnography
Measured: sleep periods following day 1, days 6-7 and days 10-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study start19 Mar 2015
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Circadian DysregulationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Frank AJL Scheer, PhD, Brigham and Women's Hospital
- Investigators
- Frank A Scheer, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291952
- Sponsor's protocol ID
- R01HL118601
- Status last verified
- Mar 2020
- First submitted
- 12 Nov 2014
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Scheer FAJL, Chellappa SL. Endogenous circadian rhythms in mood and well-being. Sleep Health. 2024 Feb;10(1S):S149-S153. doi: 10.1016/j.sleh.2023.07.012. Epub 2023 Aug 28.
PubMed 37648646Chellappa SL, Engen PA, Naqib A, Qian J, Vujovic N, Rahman N, Green SJ, Garaulet M, Keshavarzian A, Scheer FAJL. Proof-of-principle demonstration of endogenous circadian system and circadian misalignment effects on human oral microbiota. FASEB J. 2022 Jan;36(1):e22043. doi: 10.1096/fj.202101153R.
PubMed 34861073
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
- ClinicalTrials.gov ID
- NCT02291952
- Acronym / sponsor ID
- R01HL118601
- Conditions
- Circadian Dysregulation
- Keywords
- Circadian Misalignment, Forced Desynchrony, Metabolism, Meal-timing, Circadian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 17 Nov 2014 (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 goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.
Detailed description
Shift work is associated with circadian misalignment and an increased risk for the development diabetes, obesity, and cardiovascular disease. This research will determine whether changing the feeding schedule can prevent metabolic alterations that can lead to the abovementioned disorders. This research will provide mechanistic insight and may provide a novel therapeutic approach against the increased risk for diabetes, obesity, and cardiovascular disease among shift workers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Meal scheduleDuring Forced Desynchrony sleep and wake will occur at different circadian phases, while meals are restricted to the biological day. |
| Control | Other | Behavioral: Meal scheduleDuring Forced Desynchrony sleep and wake, as well as meals, will occur at different circadian phases. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI between 18.5 and 29.9 kgm-2
- Healthy adults with regular sleep-wake timing
- Non-smokers
- Completion of medical and psychological screening tests
- Able to spend 14 consecutive days in the sleep laboratory
Key exclusion criteria (9 listed)
- BMI <18.5 or > 29.9 kgm-2
- History of neurological or psychiatric disorder
- History of sleep disorder or regular use of sleep-promoting medication
- Current prescription, herbal, or over-the-counter medication use
- Traveling across 2 or more time zones within past 3 months
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 |
|---|---|---|
| Meal schedule | Behavioural | Control, Experimental |
Primary outcome
Change in plasma leptin levels across sleep/wake cycle
Time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
Change in circadian profile of plasma leptin
Time frame: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Frequent blood samples
Change in glucose tolerance
Time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma glucose levels
Time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
Change in plasma insulin levels after standardized test meal
Time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma insulin levels
Time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
5 secondary outcomes
o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol
Time frame: Core temperature and frequent blood samples
Changes circadian rhythm in resting energy expenditure
Time frame: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Change in hunger and appetite, mood, and cognitive performance
Time frame: Tests taken throughout the protocol, days 1-14
Changes in microbiota, gene expression, epigenetic or proteomic markers
Time frame: samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13)
Changes in sleep
Time frame: sleep periods following day 1, days 6-7 and days 10-11
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 19 Mar 2020.
- Derived from this study: PubMed 37648646Scheer FAJL, Chellappa SL. Endogenous circadian rhythms in mood and well-being. Sleep Health. 2024 Feb;10(1S):S149-S153. doi: 10.1016/j.sleh.2023.07.012. Epub 2023 Aug 28.
- Derived from this study: PubMed 34861073Chellappa SL, Engen PA, Naqib A, Qian J, Vujovic N, Rahman N, Green SJ, Garaulet M, Keshavarzian A, Scheer FAJL. Proof-of-principle demonstration of endogenous circadian system and circadian misalignment effects on human oral microbiota. FASEB J. 2022 Jan;36(1):e22043. doi: 10.1096/fj.202101153R.
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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.
Frank A Scheer, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal schedule in people with Circadian Dysregulation, run by Brigham and Women's Hospital at 1 site in United States.
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 5 inclusion and 9 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 19 Mar 2020. 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 United States. 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?
Change in plasma leptin levels across sleep/wake cycle (time frame: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291952, which also lists 2 linked publications.
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 19 Mar 2020.