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Time-restricted Eating in Morning Chronotype

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ClinicalTrials.gov Identifier: NCT04618133
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Tinh-Hai Collet, MD, University Hospital, Geneva

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Early time-restricted eating Behavioral: Late time-restricted eating Behavioral: Active control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Time-restricted Eating to Improve Body Fat Mass in Overweight and Obese Individuals With Morning Chronotype: A Randomized, Open-label, Multi-arm Trial
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: Early time-restricted eating
Duration: 12 weeks
Behavioral: Early time-restricted eating
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
Other Name: Early TRE

Experimental: Late time-restricted eating
Duration: 12 weeks
Behavioral: Late time-restricted eating
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
Other Name: Late TRE

Active Comparator: Active control
Duration: 12 weeks
Behavioral: Active control
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




Primary Outcome Measures :
  1. Change in body fat mass [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by dual-energy x-rax absorptiometry (DXA)


Secondary Outcome Measures :
  1. Change in physical activity [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by actigraphy

  2. Change in sleep/wake cycles [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by actigraphy

  3. Change in ambient light [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by actigraphy

  4. Change in sleep quality [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by the Pittsburgh Sleep Quality Index (scale 0-21, 0 indicating no sleeping difficulty, 21 indicating severe sleeping difficulties)

  5. Change in eating duration [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    Duration from the first to last caloric intake over 24-hour cycle

  6. Change in calorie intake over the 24-hour cycle [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    Assessed by a 24-hour food recall

  7. Change in weight [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    Body weight (kg)

  8. Change in waist circumference [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    Waist circumference (cm) assessed with a measuring tape

  9. Change in hip circumference [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    Hip circumference (cm) assessed with a measuring tape

  10. Change in systolic and diastolic blood pressure [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured with an arm cuff in the sitting position

  11. Change in fasting glucose [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured in clinical chemistry

  12. Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol) [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by clinical chemistry

  13. Change in body fat mass [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by bioelectrical impedance analysis (BIA)

  14. Change in lean body mass [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by dual-energy x-rax absorptiometry (DXA)

  15. Change in fat-free mass [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by bioelectrical impedance analysis (BIA)

  16. Change in resting energy expenditure [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by indirect calorimetry

  17. Change in glucose excursion [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by continuous glucose monitoring

  18. Incidence of adverse events in response to the randomized intervention [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0


Other Outcome Measures:
  1. Change in in vitro circadian parameters (amplitude and magnitude) [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured in cultured skin fibroblasts (in a subset of the study population)

  2. Change in metabolomic parameters [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by high-throughput mass spectrometry metabolomics

  3. Change in lipid metabolism [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    As measured by high-throughput mass spectrometry lipidomics

  4. Change in blood hormonal profile [ Time Frame: From randomization visit to close-out visit (12 weeks) ]
    Cortisol, insulin, thyroid-stimulating hormone



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical criteria

    • Men and premenopausal women
    • Age 25-50 years
    • BMI 25-34 kg/m2
    • Stable weight (maximum ± 2 kg of usual body weight) over the previous 3 months
    • Stable body fat mass (maximum ± 1 kg of body fat mass) during the run-in phase
    • Eating window ≥ 12 hours during the run-in phase
    • Morning chronotype
  • Work-related criteria

    • Daytime work at least 3 days per week over the previous 1 month and planned during the study
  • Study-related criteria

    • Able to give informed consent and follow the study procedures for the entire duration
    • Confident use of a smartphone and able to take regular pictures of food/drinks

Exclusion Criteria:

  • Clinical criteria

    • Pregnant and breastfeeding women, plans for maternity during the study
    • On a diet, intermittent fasting, in a weight management program over the previous 3 months or planned during the study
    • Eating disorder(s) or prior bariatric surgery
    • Diabetes with hypoglycemic drug(s)
    • Major illness/fever over the previous 1 month
    • Active major cardiovascular, respiratory, liver, gastrointestinal, renal, neurological or endocrine disorders
    • Coagulation disorder, on anticoagulant drug, skin disorder affecting wound healing
    • Active cancer and/or oncologic treatment over the previous 12 months
    • Major sleep disorder (including untreated sleep apnea syndrome), major mental illness
    • Consumption of > 7 standard units of alcohol per week for women and > 14 standard units of alcohol per week for men
  • Work and time-related criteria

    • Shift work, such as evening shifts or night shifts, over the previous 1 month or planned during the study
    • Travel/trip to a different time zone (≥ 2-hour time difference) over the previous 1 month or planned during the study
  • Study-related criteria and other interventions

    • Enrolled in another interventional clinical trial (medication, medical device) over the previous 1 month and planned during the study
    • Regular medications over the previous 1 month that could affect the study endpoints (e.g. centrally acting, medications affecting gut absorption, transit or weight, hypoglycemic drug, hormonal treatment...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618133


Contacts
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Contact: Tinh-Hai Collet, MD +41-22-372.93.49 tinh-hai.collet@hcuge.ch
Contact: Emma Biolley, BSc +41-79-553.04.66 emma.biolley@hcuge.ch

Locations
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Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1211
Contact: Tinh-Hai Collet, MD         
Principal Investigator: Tinh-Hai Collet, MD         
Sub-Investigator: Charna Dibner, PhD         
Sub-Investigator: Laurence Genton, MD         
Sub-Investigator: Jardena Puder, MD         
Sponsors and Collaborators
Tinh-Hai Collet, MD
Investigators
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Principal Investigator: Tinh-Hai Collet, MD Geneva University Hospitals, Geneva
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Responsible Party: Tinh-Hai Collet, MD, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04618133    
Other Study ID Numbers: 2020-01439
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight