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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK132372 | U.S. NIH Grant/Contract | View source |
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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 clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are:
Participants will be randomly assigned to either early time restricted eating, late time restricted eating, or daily caloric restriction.
This is a 52-week randomized, parallel-arm clinical trial designed to assess the effects of early time restricted eating (E-TRE) vs late TRE (L-TRE) vs daily caloric restriction (DCR) within the context of a guidelines-based behavioral weight loss program. 162 adults (age 18-65) with obesity (BMI 27-45 kg/m2) will be recruited from the community and randomized 1:1:1 to E-TRE (eating within an 8-hour window starting 1-2 hours after waking), L-TRE (eating within an 8-hour window starting 5-6 hours after waking) or DCR (caloric restriction of 25% from baseline energy requirements). The primary outcome is change in body weight at 26 weeks. Secondary outcomes include body composition, insulin sensitivity, blood pressure, glucose variability, physical activity, and sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early time restricted eating | Experimental | Participants will asked to follow early time restricted eating |
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| Late time restricted eating | Experimental | Participants will be asked to follow late time restricted eating |
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| Daily caloric restriction | Active Comparator | Participants will be instructed to follow daily caloric restriction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early TRE | Behavioral | Participants will be instructed to eat only during an 8-hour window starting 1-2 hours after waking. |
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| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) | Body weight will be measured using a digital scale at baseline, weeks 14, 26 and 52. The primary outcome will be change in weight from baseline to 26 weeks. | 0 to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass | Fat mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52 | 0 to 52 weeks |
| Lean mass | Lean mass will assessed using Dual-Energy X-Ray Absorptiometry (DXA) at baseline, weeks 14, 26 and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Health and Wellness Center | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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randomized, parallel-arm clinical trial
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| Late TRE | Behavioral | Participants will be instructed to eat only during an 8-hour window starting 5-6 hours after waking. |
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| DCR | Behavioral | Participants will be instructed to reduce caloric intake by 25%. |
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| 0-52 weeks |
| Blood pressure | Systolic and diastolic blood pressure will be measured at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| HbA1c | HbA1c will be measured at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| Insulin sensitivity | Insulin sensitivity measured with oral glucose tolerance test at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| 24-hour glucose levels | 24-hr glucose levels measured with continuous glucose monitor at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| Physical activity | Total steps measured with activPal device at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| Total cholesterol concentration | Total cholesterol concentration will be measured at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| Sleep duration | Sleep duration (minutes) will be measured with activPal device at baseline and weeks 0, 14 and 26 | 0-52 weeks |
| LDL cholesterol concentration | Low density lipoprotein (LDL) will be measured at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| HDL cholesterol concentration | High density lipoprotein (HDL) cholesterol concentration will be measured at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| Triglyceride concentration | Triglyceride concentration will be measured at baseline and weeks 14, 26 and 52 | 0-52 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |