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The overarching aim of this research is to study the effects of caloric content and timing of meals on measures of postprandial metabolism and cardiovascular response
Hypothesis: 1) that hypercaloric meals will result in significantly reduced indices of metabolic flexibility and pulse wave analysis as compared to eucaloric meals and 2) eucaloric meals consumed later in the day will result in significantly reduced metabolic flexibility and pulse wave analysis as compared to eucaloric meals consumed in the morning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eucaloric Morning Mixed Meal Challenge | Active Comparator | Morning Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need |
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| Eucaloric Evening Mixed Meal Challenge | Experimental | Evening Mixed Meal Challenge (Liquid Shake), 25% of estimated daily caloric need |
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| Hypercaloric Morning Mixed Meal Challenge | Experimental | Morning Mixed Meal Challenge (Liquid Shake), 37.5% of estimated daily caloric need |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixed Meal Feeding Challenge | Other | Liquid flavored Ensure Plus Shake of varying caloric content based on individual daily estimated caloric need |
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| Measure | Description | Time Frame |
|---|---|---|
| Pulse Wave Analysis | Augmentation Index normalized to 75 beats per minute as index of pulse wave reflection | Baseline to 60 and 120 minutes postprandial |
| Postprandial Substrate Oxidation | Respiratory Exchange Ratio | Baseline to 120 minutes postprandial |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University School of Public Health | Washington D.C. | District of Columbia | 20052 | United States |
Anonymized participant data will be shared with researchers upon resonable request and data will be deposited on Open Science Framework
June 2026 upon completion of primary data collection and analysis of primary outcomes
Researchers making reasonable requests for data access will be granted permission and access to primary data files. Researchers will be asked to submit a scientific question and rationale for data access along with a data analysis plan. Researchers will intiiate a Data Use Agreement with Principal Investigators.
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3 arm randomized cross-over trial
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