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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The goal of this clinical trial is to test the effects of dietary composition on the rhythms of food intake, appetite regulation, and rhythms of energy expenditure.
Participants will:
complete 2 field-based dietary interventions be provided with standard meals record daily food intake in a real-time manner complete 2 inpatient stays be provided with standard meals have frequent blood draws provide urine, saliva, and stool samples
Obesity is an ongoing epidemic and a serious public health problem. Recent insights into the involvement of the circadian system (i.e., an internal biological rhythm) in energy expenditure and appetite control offer a new perspective to understand the relationship between dietary composition and weight management. Particularly, dietary composition may impact whole-body physiology in part through changes in the circadian system. The study protocol is designed to test the effects of dietary composition, on the rhythms of food intake and appetite regulation, and rhythms of energy expenditure. This study seeks to understand the relationship between dietary composition and weight control in order to lay the groundwork for evidence-based dietary intervention to combat obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary A-B Intervention | Experimental | The Dietary A first, then the Dietary B 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. |
|
| Dietary B-A Intervention | Experimental | The Dietary B first, then the Dietary A 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. |
|
| 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 |
|---|---|---|
| Circadian phase of melatonin rhythm | Hourly plasma melatonin will be measured under the Constant Routine condition | Days 18-19 |
| Percentage of daily caloric intake in the biological evening | Percentage of caloric intake within the 4 hours before bedtime will be derived from real-time record of food and beverage intake during the intervention period | Days 8-14 |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian amplitude of melatonin rhythm | Hourly circulating melatonin will be measured under the Constant Routine condition | Days 18-19 |
| Circadian amplitude of subjective hunger rhythms | Hourly subjective hunger will be measured by Visual Analog Scale under the Constant Routine condition |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal variations of postprandial ghrelin responses | Postprandial circulating ghrelin will be measured at test meals on Test Day | Days 17 |
| Diurnal profile of leptin | Circulating leptin will be measured hourly on Test Day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank A.J.L. Scheer, PhD | Contact | 617-732-7014 | FSCHEER@BWH.HARVARD.EDU | |
| Jingyi Qian, PhD | Contact | 617-525-7423 | jqian@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank AJL 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 |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Days 18-19 |
| Circadian phase of resting energy expenditure | Every other hour energy expenditure will be measured by indirect calorimetry under the Constant Routine condition | Days 18-19 |
| Days 17 |
| Diurnal profile of subjective hunger ratings | Hourly subjective hunger will be measured by Visual Analog Scale on Test Day | Day 17 |
| Circadian amplitude of resting energy expenditure | Every other hour resting energy expenditure will be measured by indirect calorimetry under the Constant Routine condition | Days 18-19 |
| Diurnal profile of resting energy expenditure | Indirect calorimetry will be done 30 minutes before each test meal and three 30-minute postprandial tests starting at 30, 90, and 240 min after each test meal on Test day by indirect calorimetry | Day 17 |
| Diurnal profile of respiratory exchange ratio | Respiratory exchange ratio will be measured 30 minutes before each test meal and three 30-minute postprandial tests starting at 30, 90, and 240 min after each test meal on Test Day by indirect calorimetry | Day 17 |
| Circadian amplitude and phase of respiratory exchange ratio | Every other hour respiratory exchange ratio will be measured by indirect calorimetry under the Constant Routine condition | Days 18-19 |
| Circadian phase and amplitude of glucose rhythm | Hourly circulating glucose will be measured under the Constant Routine condition | Days 18-19 |
| Circadian phase and amplitude of insulin rhythm | Hourly circulating insulin will be measured under the Constant Routine condition | Days 18-19 |
| Circadian phase and amplitude of cortisol rhythm | Hourly circulating cortisol will be measured under the Constant Routine condition | Days 18-19 |
| Circadian phase and amplitude of core body temperature rhythm | Core body temperature will be measured continuously under the Constant Routine condition | Days 18-19 |
| Diurnal profile of lipids | Hourly circulating lipids will be measured on Test Day | Day 17 |
| Circadian phase and amplitude of lipids | Hourly circulating lipids will be measured under Constant Routine condition | Days 18-19 |