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Overweight and obesity are highly prevalent conditions worldwide, despite active research of new interventions over decades. Current interventions include medications or bariatric surgery, but these approaches cannot be used in all patients and require clear indications and a close multidisciplinary management. Therefore most patients and physicians rely on lifestyle interventions, focusing on a balanced diet and physical exercise.
Recent studies have uncovered that energy metabolism is also regulated by circadian rhythms, which depend on spontaneous diurnal oscillations of the central clock, retinal sensing of ambient light, and daily feeding-fasting cycles. The chronotype has an influence on behavioral patterns, where some people describe that they are more alert in the morning or in the evening: The morning or evening chronotypes, respectively. However, in modern societies, many people are exposed to external cues in misalignment with their circadians clocks. The mismatch between the individual chronotype and the social/work life can lead to metabolic disorders.
Time-restricted eating (TRE), i.e. energy intake limited to certain windows of time without restricting calories, is an appealing approach because it proposes to realign the circadian clocks with external cues provided by the timing of food intake, thus leading to better metabolic outcomes.
The investigators speculate that the TRE intervention needs to be personalized to reach efficacy in a broader population. To tailor the TRE intervention to each individual and harmonize their eating patterns in accordance to their chronotype, the investigators plan to test early TRE vs. late TRE vs. active control in overweight and obese individuals with morning chronotype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early time-restricted eating | Experimental | Duration: 12 weeks |
|
| Late time-restricted eating | Experimental | Duration: 12 weeks |
|
| Active control | Active Comparator | Duration: 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early time-restricted eating | Behavioral | Participants will be advised to eat only during a selected window of 8 hours over the 24-hour cycle, i.e. from 6am to 2pm, with a 1-hour allowance according to their daily routine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body fat mass | As measured by dual-energy x-rax absorptiometry (DXA) | From randomization visit to close-out visit (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical activity | As measured by actigraphy | From randomization visit to close-out visit (12 weeks) |
| Change in sleep/wake cycles | As measured by actigraphy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in in vitro circadian parameters (amplitude and magnitude) | As measured in cultured skin fibroblasts (in a subset of the study population) | From randomization visit to close-out visit (12 weeks) |
| Change in metabolomic parameters |
Inclusion Criteria:
Clinical criteria
Work-related criteria
Study-related criteria
Exclusion Criteria:
Clinical criteria
Work and time-related criteria
Study-related criteria and other interventions
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| Name | Affiliation | Role |
|---|---|---|
| Tinh-Hai Collet, MD | Geneva University Hospitals, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | 1211 | Switzerland |
Not provided
| 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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|
| Late time-restricted eating | Behavioral | Participants will be advised to eat only during a selected window of 8 hours over the 24-hour cycle, i.e. from noon to 8pm, with a 1-hour allowance according to their daily routine |
|
|
| Active control | Behavioral | Participants will be advised to eat a minimum of 3 meals over the 24-hour cycle, i.e. breakfast from 6am to 9am, lunch from 11am to 2pm, dinner from 6pm to 10pm. Snacks will be allowed between meals |
|
| From randomization visit to close-out visit (12 weeks) |
| Change in ambient light | As measured by actigraphy | From randomization visit to close-out visit (12 weeks) |
| Change in sleep quality | As measured by the Pittsburgh Sleep Quality Index (scale 0-21, 0 indicating no sleeping difficulty, 21 indicating severe sleeping difficulties) | From randomization visit to close-out visit (12 weeks) |
| Change in eating duration | Duration from the first to last caloric intake over 24-hour cycle | From randomization visit to close-out visit (12 weeks) |
| Change in calorie intake over the 24-hour cycle | Assessed by a 24-hour food recall | From randomization visit to close-out visit (12 weeks) |
| Change in weight | Body weight (kg) | From randomization visit to close-out visit (12 weeks) |
| Change in waist circumference | Waist circumference (cm) assessed with a measuring tape | From randomization visit to close-out visit (12 weeks) |
| Change in hip circumference | Hip circumference (cm) assessed with a measuring tape | From randomization visit to close-out visit (12 weeks) |
| Change in systolic and diastolic blood pressure | As measured with an arm cuff in the sitting position | From randomization visit to close-out visit (12 weeks) |
| Change in fasting glucose | As measured in clinical chemistry | From randomization visit to close-out visit (12 weeks) |
| Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol) | As measured by clinical chemistry | From randomization visit to close-out visit (12 weeks) |
| Change in body fat mass | As measured by bioelectrical impedance analysis (BIA) | From randomization visit to close-out visit (12 weeks) |
| Change in lean body mass | As measured by dual-energy x-rax absorptiometry (DXA) | From randomization visit to close-out visit (12 weeks) |
| Change in fat-free mass | As measured by bioelectrical impedance analysis (BIA) | From randomization visit to close-out visit (12 weeks) |
| Change in resting energy expenditure | As measured by indirect calorimetry | From randomization visit to close-out visit (12 weeks) |
| Change in glucose excursion | As measured by continuous glucose monitoring | From randomization visit to close-out visit (12 weeks) |
| Incidence of adverse events in response to the randomized intervention | Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0 | From randomization visit to close-out visit (12 weeks) |
As measured by high-throughput mass spectrometry metabolomics
| From randomization visit to close-out visit (12 weeks) |
| Change in lipid metabolism | As measured by high-throughput mass spectrometry lipidomics | From randomization visit to close-out visit (12 weeks) |
| Change in blood hormonal profile | Cortisol, insulin, thyroid-stimulating hormone | From randomization visit to close-out visit (12 weeks) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |