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The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants.
Participants will:
The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Day shift protocol with diet A | Experimental | Day shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. |
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| Day shift protocol with diet B | Experimental | Day shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. |
|
| Night shift protocol with diet A | Experimental | Night shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. |
|
| Night shift protocol with diet B | Experimental | Night shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Day shift protocol - Diet order A-B | Behavioral | Research participants will be assigned to day shift condition and Diet A-B order condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in glucose tolerance between Meal Conditions and Shift Work | Glucose incremental area under the curve (AUC) from mixed meal tests | 24 hours |
| Difference in diet-induced thermogenesis between Meal Conditions and Shift Work | Postprandial energy expenditure incremental area under the curve (AUC) from mixed meal tests | 24 hours |
| Difference in plasma triglyceride level between Meal Conditions and Shift Work | Triglyceride area under the curve (AUC) over 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in insulin sensitivity between Meal Conditions and Shift Work | Insulin sensitivity index derived from Oral Minimal Model | 24 hours |
| Difference in beta-cell function between Meal Conditions and Shift Work |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioannis Lempesis, MD, PhD, PhD | Contact | 6177326256 | timedstudy@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank Scheer, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| Day shift protocol - Diet order B-A | Behavioral | Research participants will be assigned to day shift condition and Diet B-A order condition. |
|
| Night shift protocol - Diet order A-B | Behavioral | Research participants will be assigned to simulated night shift condition and Diet A-B order condition. |
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| Night shift protocol - Diet order B-A | Behavioral | Research participants will be assigned to simulated night shift condition and Diet B-A order condition. |
|
Beta-cell function index derived from Oral Minimal Model
| 24 hours |
| Difference in 24-h glycemia between Meal Conditions and Shift Work | Glucose area under the curve (AUC) based on CGM over 24 hours | 24 hours |
| Difference in postprandial incretin level between Meal Conditions and Shift Work | Incretin incremental area under the curve (AUC) from mixed meal tests | 24 hours |
| Difference in substrate oxidation between Meal Conditions and Shift Work | Postprandial substrate oxidation incremental area under the curve (AUC) from mixed meal tests | 24 hours |
| Difference in plasma free fatty acids level between Meal Conditions and Shift Work | Free fatty acids area under the curve (AUC) over 24 hours | 24 hours |