ObesityCMNCT03663530
Circadian Misalignment and Energy Balance
A study testing Meal times in people with Obesity, run by Columbia University at 1 site in United States.
Trial summary
Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance… Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Meal times
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All racial and ethnic groups
- Body mass index 20-34.9 kg/m2
- Average sleep duration ≥7 hour/night, assessed during 2-week screening period
- Eat within 1 hour of awakening at least 5 days/week
- Midpoint of sleep at 4 AM or earlier
Who cannot join
- <10 nights of sleep <7 hour during the 2-week screening period
- Daytime napping
- Current or past sleep disorder (Sleep Disorders Inventory); Insomnia Severity Index Score >10
- Current or past psychiatric disorder, including eating disorders and seasonal affective disorder
- Any psychological or psychiatric disorder deemed to interfere with study outcomes
- Smoking (currently smoking any cigarettes or using tobacco products, e-cigarettes and vapes, or ex-smokers <3 years)
Show all 22Show fewer
- Night and rotating shift work
- Travel across time zones within 4 wk of the study
- History of drug or alcohol abuse or excessive alcohol consumption (>3 drinks/day for men or 2 for women)
- Recent weight change (>5% gain or loss of body weight over past 3 months) or active participation in diet or weight loss program in previous 3 months; any weight loss procedure
- Pregnancy or <1 year post-partum
- Diagnosed sleep apnea or high-risk score on Berlin questionnaire (2 or more categories with positive score)
- Depression (score >13 on Beck Depression Inventory II) or taking anti-depressive medications
- Restless leg syndrome and circadian rhythm disorders
- Dementia or cognitive impairments
- Taking psychoactive or hypnotic medications
- Taking chronic analgesic or anti-inflammatory medications
- Having had gastrointestinal surgery, including gastric bypass surgery
- Restrained eating or abnormal scores on the Three Factor Eating Questionnaire
- Contraindications for magnetic resonance imaging scanning
- Hematocrit <30%
- Taking beta blockers, as this can interfere with melatonin secretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Impact of Circadian Misalignment on Energy Balance Regulation
Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.
Read the detailed description
The proposed study will test whether the misalignment of eating occasions to the sleep period influences health markers. The goal of the proposed study is to determine whether eating out of synchrony with sleep influences risk of chronic diseases. The proposed study has both mechanistic and translational objectives. First, the investigators will test whether eating late in the day will influence energy balance (hormones, energy expenditure, nutritional intakes). Next, they will observe how misaligned meals, relative to aligned meals, influence behavior. Overweight men and women will be recruited to participate in a 2-phase, crossover study, with constant sleep periods. Phases will only differ in the alignment of meals to the sleep period: aligned = meals starting 1 h after awakening; misaligned = meals starting 5 h after awakening. Mechanistic aims will be addressed from measurements taken after 3 and 14 d of the intervention. The translational aim will be addressed after a 4 wk free-living period following the prescribed meal times for each phase. This proposed study, which will manipulate meal timing, without affecting total sleep time, is important because it will provide information on the mechanism by which circadian misalignment influences health. As such, the proposed study will be a stepping-stone in the establishment of lifestyle recommendations or therapies to personalize chronotype to reduce the risk of chronic diseases.
- Conditions
- Obesity
- Being tested
- Meal times
- Keywords
- Food intake, Energy expenditure, Body composition, Meal timing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal timesBehavioural
Meal times vary based on the arm: aligned or misaligned
| Study group | Role | What they receive |
|---|---|---|
| Circadian misalignment | Experimental | Meals in this condition will be delayed by 4 hours relative to the circadian alignment condition. Food intake during this period will be from 1 PM to 11 PM. Receives: Behavioral: Meal times |
| Circadian alignment | Active comparator | Meals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM. Receives: Behavioral: Meal times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
Metabolic chamber
Measured: Change over 2-week period
Body composition
Quantitative magnetic resonance
Measured: Change over 4-week period
Nutritional intakes
3-day food records
Measured: 4 weeks
Secondary outcomes (4)
Task-based functional neuroimaging
Brain responses to food stimuli
Measured: Change over 2-week period
Resting state functional neuroimaging
Functional neuroimaging
Measured: Change over 2-week period
Appetite
Visual analog scales
Measured: 4 weeks
Hormones
Leptin, ghrelin, peptide tyrosine tyrosine, glucagon-like peptide 1
Measured: Change over 2-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jan 2019
- Primary completion31 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 2-period crossover study in which sleep is identical in duration and timing but meals/food intake is varied relative to the sleep episode.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663530
- Sponsor's protocol ID
- AAAR9547
- Acronym
- CM
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2018
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. We plan to follow the HIPAA privacy rule for de-identification of a dataset before transferring data.
Publications
Boege HL, Wilson KD, Kilkus JM, Qiu W, Cheng B, Wroblewski KE, Tucker B, Tasali E, St-Onge MP. Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults. Sleep Health. 2025 Oct;11(5):590-596. doi: 10.1016/j.sleh.2025.05.003. Epub 2025 Jun 11.
PubMed 40506285
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circadian Misalignment on Energy Balance Regulation
- ClinicalTrials.gov ID
- NCT03663530
- Acronym / sponsor ID
- CM / AAAR9547
- Conditions
- Obesity
- Keywords
- Food intake, Energy expenditure, Body composition, Meal timing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Sep 2018 (actual)
- 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.
Preliminary findings from the investigators' lab suggest that circadian misalignment, occurring when meals and sleep are mistimed from one another, alters resting state neuronal processing in areas relevant to food reward and interoception; supporting a role of sleep and meal misalignment, on energy balance regulation. No study has been done to disentangle the effects of sleep and meal timing on body weight regulation, independent of sleep duration. This study will provide information to guide messaging related to timing of meals and sleep that can be translated to individuals whose sleep follows unconventional times, such as shift workers and those with jetlag and social jetlag.
Detailed description
The proposed study will test whether the misalignment of eating occasions to the sleep period influences health markers. The goal of the proposed study is to determine whether eating out of synchrony with sleep influences risk of chronic diseases. The proposed study has both mechanistic and translational objectives. First, the investigators will test whether eating late in the day will influence energy balance (hormones, energy expenditure, nutritional intakes). Next, they will observe how misaligned meals, relative to aligned meals, influence behavior. Overweight men and women will be recruited to participate in a 2-phase, crossover study, with constant sleep periods. Phases will only differ in the alignment of meals to the sleep period: aligned = meals starting 1 h after awakening; misaligned = meals starting 5 h after awakening. Mechanistic aims will be addressed from measurements taken after 3 and 14 d of the intervention. The translational aim will be addressed after a 4 wk free-living period following the prescribed meal times for each phase. This proposed study, which will manipulate meal timing, without affecting total sleep time, is important because it will provide information on the mechanism by which circadian misalignment influences health. As such, the proposed study will be a stepping-stone in the establishment of lifestyle recommendations or therapies to personalize chronotype to reduce the risk of chronic diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a 2-period crossover study in which sleep is identical in duration and timing but meals/food intake is varied relative to the sleep episode.
| Arm | Type | Receives |
|---|---|---|
| Circadian misalignment | Experimental | Behavioral: Meal timesMeals in this condition will be delayed by 4 hours relative to the circadian alignment condition. Food intake during this period will be from 1 PM to 11 PM. |
| Circadian alignment | Active comparator | Behavioral: Meal timesMeals in this condition will be aligned to the sleep episode. Food intake during this period will be from 9 AM to 7 PM. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All racial and ethnic groups
- Body mass index 20-34.9 kg/m2
- Average sleep duration ≥7 hour/night, assessed during 2-week screening period
- Eat within 1 hour of awakening at least 5 days/week
- Midpoint of sleep at 4 AM or earlier
Key exclusion criteria (22 listed)
- <10 nights of sleep <7 hour during the 2-week screening period
- Daytime napping
- Current or past sleep disorder (Sleep Disorders Inventory); Insomnia Severity Index Score >10
- Current or past psychiatric disorder, including eating disorders and seasonal affective disorder
- Any psychological or psychiatric disorder deemed to interfere with study outcomes
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 timesMeal times vary based on the arm: aligned or misaligned | Behavioural | Circadian alignment, Circadian misalignment |
Primary outcome
Energy expenditure
Time frame: Change over 2-week period
Metabolic chamber
Body composition
Time frame: Change over 4-week period
Quantitative magnetic resonance
Nutritional intakes
Time frame: 4 weeks
3-day food records
4 secondary outcomes
Task-based functional neuroimaging
Time frame: Change over 2-week period
Resting state functional neuroimaging
Time frame: Change over 2-week period
Appetite
Time frame: 4 weeks
Hormones
Time frame: Change over 2-week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 40506285Boege HL, Wilson KD, Kilkus JM, Qiu W, Cheng B, Wroblewski KE, Tucker B, Tasali E, St-Onge MP. Higher daytime intake of fruits and vegetables predicts less disrupted nighttime sleep in younger adults. Sleep Health. 2025 Oct;11(5):590-596. doi: 10.1016/j.sleh.2025.05.003. Epub 2025 Jun 11.
- Individual participant dataSharing planned: Yes. Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. We plan to follow the HIPAA privacy rule for de-identification of a dataset before transferring data.
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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.
Marie-Pierre St-Onge, PhD principal investigator
Columbia University
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 times in people with Obesity, run by Columbia University 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 22 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Energy expenditure (time frame: Change over 2-week period). The study lists 3 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 NCT03663530, which also lists 1 linked publication.
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 21 Sep 2026.