An interventional study of Early time-restricted eating and Late time-restricted eating in Overweight and Obesity, sponsored by Tinh-Hai Collet, MD. Completed at 1 site in Switzerland. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Tinh-Hai Collet, MD · Not applicable, Interventional, and Treatment
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.
3,771 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 92 is above the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →Tinh-Hai Collet, MD is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Clinical criteria
Work-related criteria
Study-related criteria
Exclusion Criteria:
Clinical criteria
Work and time-related criteria
Study-related criteria and other interventions
Duration: 12 weeks
Behavioral: Early time-restricted eating
Duration: 12 weeks
Behavioral: Late time-restricted eating
Duration: 12 weeks
Behavioral: Active control
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
Also known as: Early TRE
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
Also known as: Late TRE
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
Change in body fat mass
As measured by dual-energy x-rax absorptiometry (DXA)
Time frame: From randomization visit to close-out visit (12 weeks)
Change in physical activity
As measured by actigraphy
Time frame: From randomization visit to close-out visit (12 weeks)
Change in sleep/wake cycles
As measured by actigraphy
Time frame: From randomization visit to close-out visit (12 weeks)
Change in ambient light
As measured by actigraphy
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From randomization visit to close-out visit (12 weeks)
Change in weight
Body weight (kg)
Time frame: From randomization visit to close-out visit (12 weeks)
Change in waist circumference
Waist circumference (cm) assessed with a measuring tape
Time frame: From randomization visit to close-out visit (12 weeks)
Change in hip circumference
Hip circumference (cm) assessed with a measuring tape
Time frame: 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
Time frame: From randomization visit to close-out visit (12 weeks)
Change in fasting glucose
As measured in clinical chemistry
Time frame: 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
Time frame: From randomization visit to close-out visit (12 weeks)
Change in body fat mass
As measured by bioelectrical impedance analysis (BIA)
Time frame: From randomization visit to close-out visit (12 weeks)
Change in lean body mass
As measured by dual-energy x-rax absorptiometry (DXA)
Time frame: From randomization visit to close-out visit (12 weeks)
Change in fat-free mass
As measured by bioelectrical impedance analysis (BIA)
Time frame: From randomization visit to close-out visit (12 weeks)
Change in resting energy expenditure
As measured by indirect calorimetry
Time frame: From randomization visit to close-out visit (12 weeks)
Change in glucose excursion
As measured by continuous glucose monitoring
Time frame: 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
Time frame: From randomization visit to close-out visit (12 weeks)
Change in in vitro circadian parameters (amplitude and magnitude)
As measured in cultured skin fibroblasts (in a subset of the study population)
Time frame: From randomization visit to close-out visit (12 weeks)
Change in metabolomic parameters
As measured by high-throughput mass spectrometry metabolomics
Time frame: From randomization visit to close-out visit (12 weeks)
Change in lipid metabolism
As measured by high-throughput mass spectrometry lipidomics
Time frame: From randomization visit to close-out visit (12 weeks)
Change in blood hormonal profile
Cortisol, insulin, thyroid-stimulating hormone
Time frame: From randomization visit to close-out visit (12 weeks)
Ran from Jan 2021 to primary completion in Jul 2024, 42 months.
Of 1,356 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 42 months is above that.
Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Tinh-Hai Collet, MD