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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal times | Behavioral | Meal times vary based on the arm: aligned or misaligned |
|
| Measure | Description | Time Frame |
|---|---|---|
| Energy expenditure | Metabolic chamber | Change over 2-week period |
| Body composition | Quantitative magnetic resonance | Change over 4-week period |
| Nutritional intakes | 3-day food records | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Task-based functional neuroimaging | Brain responses to food stimuli | Change over 2-week period |
| Resting state functional neuroimaging | Functional neuroimaging |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian rhythms | Melatonin and cortisol | Change over 2-week period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diane Hawkins | Contact | 212 305 9379 | dh3078@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Pierre St-Onge, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40506285 | Derived | 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. |
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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.
Data will become available after results of the main aims from the final dataset have been accepted for publication.
Our methods of data sharing include: mailing CD-ROM containing data or e-mailing data files directly to the requestors. Normally, our data files are available in Excel or SAS format. Other data file formats can also be requested. The study's Statisticians will assist in preparing the required data files for data sharing. fMRI data will be uploaded to a data file sharing repository for anyone to use. These data will be de-identified prior to release.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D062407 | Meals |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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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.
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Participants will be masked to the true outcomes of the study.
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| Change over 2-week period |
| Appetite | Visual analog scales | 4 weeks |
| Hormones | Leptin, ghrelin, peptide tyrosine tyrosine, glucagon-like peptide 1 | Change over 2-week period |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |