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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL153969 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.
Participants will:
Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-Dietary Intervention | Experimental | Control condition first, then the Dietary intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. |
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| Dietary intervention-Control | Experimental | Dietary intervention first, then the Control condition. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary intervention | Behavioral | Research participants will be assigned to two dietary conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose tolerance from Baseline to Test Day | Change in incremental glucose area under the curve (AUC) from a mixed meal test. | Baseline (Day 2) and Test Day (Day 4) |
| Changes in microbial community structure/composition/function of oral and gut microbiome from Baseline to Test Day | Shotgun metagenomics sequencing or 16S rRNA sequencing of saliva, stool, and rectal swab samples will provide in-depth interrogation of the microbial community structure, composition, and function. | Baseline (Day 2) and Test Day (Day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day | Oral Minimal Model method estimates insulin sensitivity based on blood glucose and insulin levels from a mixed meal test. | Baseline (Day 2) and Test Day (Day 4) |
| Change in levels of serum markers of gut microbiota from Baseline to Test Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Munn | Contact | 6175258259 | mmunn@bwh.harvard.edu | |
| Han-Chow Koh, PhD | Contact | 6172780924 | hkoh@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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| ID | Term |
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| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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Levels of markers of gut microbiota (e.g. short chain fatty acids) will be measured in serum samples taken 3-hourly over 24 hr. |
| Baseline (Day 2) and Test Day (Day 4) |
| Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day | Levels of markers of intestinal barrier integrity (e.g. zonulin, LPS, LBP) will be measured in serum samples taken 3-hourly over 24 hr. | Baseline (Day 2) and Test Day (Day 4) |
| Change in level of serum markers of inflammatory state from Baseline to Test Day | Levels of markers of inflammatory state (e.g., cytokines) will be measured in serum samples taken 3-hourly over 24 hr. | Baseline (Day 2) and Test Day (Day 4) |