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Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRE group | Experimental | Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks. |
|
| Control group | Active Comparator | Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted eating | Behavioral | Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity | Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers. | 3 months (pre-post intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 24 h glycemic control | Changes in plasma glucose concentration will be assessed during a 24 h feeding study. | 3 months (pre-post intervention) |
| Adipose tissue gene expression | Changes in the expression of genes involved in energy metabolism will be assessed by using quantitative polymerase chain reaction (qPCR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Chondronikola | Contact | 01223746784 | mc2425@medschl.cam.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Clinical Research Center | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Extended eating window | Behavioral | Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks. |
|
| Healthy diet | Behavioral | Participants will be provided nutrition education and counselling to follow a diet consistent with the existing guidelines for chronic disease prevention. |
|
| 3 months (pre-post intervention) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |