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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this application is to understand the connection between people's eating habits and the risk for developing diabetes, obesity, and cardiovascular disease.
More than a third of U.S. adults are obese (BMI greater than 30), 8-12% of adults suffer from type 2 diabetes, and up to 30% of adults have pre-diabetes. Recent research studies have suggested that it is not just what we eat, but also when we eat that may put us at risk for obesity and type 2 diabetes. Skipping breakfast and eating late at night have been associated with an increased risk for obesity and type 2 diabetes (T2D), substantiated by recent animal and human experimental studies showing that altered meal timing itself, without changes in caloric intake, can influence weight regulation and impaired glucose tolerance. This research will determine in prediabetic and non-diabetic participants whether delaying meal times worsens glucose tolerance, leads to physiological changes favoring a positive energy balance, and increases caloric intake. This research will provide mechanistic insights into the metabolic consequences of changing meal timing and may help in evidence-based approaches to improve dietary interventions in the fight against obesity and T2D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Meals | Experimental | Meals are eaten early in the wake episode |
|
| Late Meals | Experimental | Meals are eaten late in the wake episode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal schedule | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma leptin levels across sleep/wake cycle | Frequent blood samples | During standardized meals scheduled on Days 3 and 6 |
| Change in circadian profile of plasma leptin | Frequent blood samples | During constant routine (Days 7-8) |
| Change in glucose tolerance | Frequent blood samples | During standardized meals scheduled on Days 3 and 6 |
| Change in circadian profile of plasma glucose levels | Frequent blood samples | During constant routine (Days 7-8) |
| Change in plasma insulin levels after standardized test meal | Frequent blood samples | During standardized meals scheduled on Days 3 and 6 |
| Change in circadian profile of plasma insulin levels | Frequent blood samples | During constant routine (Days 7-8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in circadian phase markers, such as from core body temperature, melatonin, cortisol | Core temperature and frequent blood samples | During constant routine (Days 7-8) |
| Changes circadian rhythm in resting energy expenditure |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42190872 | Derived | Vujovic N, Koh HE, Heng SW, Panjwani P, Van Zee C, Wang W, Qian J, Garaulet M, Scheer FAJL. Constant-routine protocol reveals an endogenous circadian rhythm in diet-induced thermogenesis with a peak in the biological morning. Metabolism. 2026 May 25;182:156655. doi: 10.1016/j.metabol.2026.156655. Online ahead of print. | |
| 36198293 | Derived | Vujovic N, Piron MJ, Qian J, Chellappa SL, Nedeltcheva A, Barr D, Heng SW, Kerlin K, Srivastav S, Wang W, Shoji B, Garaulet M, Brady MJ, Scheer FAJL. Late isocaloric eating increases hunger, decreases energy expenditure, and modifies metabolic pathways in adults with overweight and obesity. Cell Metab. 2022 Oct 4;34(10):1486-1498.e7. doi: 10.1016/j.cmet.2022.09.007. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Indirect calorimetry
| During constant routine (Days 7-8) |
| Change in hunger and appetite, mood, and cognitive performance | Subjective ratings and cognitive tests performed via computer interface | Tests taken throughout the protocol, Days 1-9 |
| Changes in microbiota, gene expression, epigenetic or proteomic markers | Frequent blood samples and saliva samples | Throughout the protocol during Days 3 and 6, and during constant routine (Days 7-8) |
| Changes in sleep | Polysomnography | Sleep will be measured during the night after Days 2 and 5 |
| Change in insulin sensitivity, gene expression, epigenetic, lipidomic or proteomic markers from isolated adipocytes | 2 fat biopsies, one sample will be taken during each protocol | On Day 5 of each protocol |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |