Back to resultsTime-restricted Eating in Morning Chronotype
Primary Purpose
Overweight and Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Early time-restricted eating
Late time-restricted eating
Active control
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility 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...)
Sites / Locations
- Geneva University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Early time-restricted eating
Late time-restricted eating
Active control
Arm Description
Duration: 12 weeks
Duration: 12 weeks
Duration: 12 weeks
Outcomes
Primary Outcome Measures
Change in body fat mass
As measured by dual-energy x-rax absorptiometry (DXA)
Secondary Outcome Measures
Change in physical activity
As measured by actigraphy
Change in sleep/wake cycles
As measured by actigraphy
Change in ambient light
As measured by actigraphy
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)
Change in eating duration
Duration from the first to last caloric intake over 24-hour cycle
Change in calorie intake over the 24-hour cycle
Assessed by a 24-hour food recall
Change in weight
Body weight (kg)
Change in waist circumference
Waist circumference (cm) assessed with a measuring tape
Change in hip circumference
Hip circumference (cm) assessed with a measuring tape
Change in systolic and diastolic blood pressure
As measured with an arm cuff in the sitting position
Change in fasting glucose
As measured in clinical chemistry
Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol)
As measured by clinical chemistry
Change in body fat mass
As measured by bioelectrical impedance analysis (BIA)
Change in lean body mass
As measured by dual-energy x-rax absorptiometry (DXA)
Change in fat-free mass
As measured by bioelectrical impedance analysis (BIA)
Change in resting energy expenditure
As measured by indirect calorimetry
Change in glucose excursion
As measured by continuous glucose monitoring
Incidence of adverse events in response to the randomized intervention
Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0
Full Information
NCT ID
NCT04618133
First Posted
October 28, 2020
Last Updated
September 27, 2022
Sponsor
Tinh-Hai Collet, MD
1. Study Identification
Unique Protocol Identification Number
NCT04618133
Brief Title
Time-restricted Eating in Morning Chronotype
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tinh-Hai Collet, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early time-restricted eating
Arm Type
Experimental
Arm Description
Duration: 12 weeks
Arm Title
Late time-restricted eating
Arm Type
Experimental
Arm Description
Duration: 12 weeks
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
Duration: 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Early time-restricted eating
Other Intervention Name(s)
Early TRE
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Late time-restricted eating
Other Intervention Name(s)
Late TRE
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Active control
Intervention Description
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 Measure Information:
Title
Change in body fat mass
Description
As measured by dual-energy x-rax absorptiometry (DXA)
Time Frame
From randomization visit to close-out visit (12 weeks)
Secondary Outcome Measure Information:
Title
Change in physical activity
Description
As measured by actigraphy
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in sleep/wake cycles
Description
As measured by actigraphy
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in ambient light
Description
As measured by actigraphy
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in sleep quality
Description
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)
Title
Change in eating duration
Description
Duration from the first to last caloric intake over 24-hour cycle
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in calorie intake over the 24-hour cycle
Description
Assessed by a 24-hour food recall
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in weight
Description
Body weight (kg)
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in waist circumference
Description
Waist circumference (cm) assessed with a measuring tape
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in hip circumference
Description
Hip circumference (cm) assessed with a measuring tape
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in systolic and diastolic blood pressure
Description
As measured with an arm cuff in the sitting position
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in fasting glucose
Description
As measured in clinical chemistry
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol)
Description
As measured by clinical chemistry
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in body fat mass
Description
As measured by bioelectrical impedance analysis (BIA)
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in lean body mass
Description
As measured by dual-energy x-rax absorptiometry (DXA)
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in fat-free mass
Description
As measured by bioelectrical impedance analysis (BIA)
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in resting energy expenditure
Description
As measured by indirect calorimetry
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in glucose excursion
Description
As measured by continuous glucose monitoring
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Incidence of adverse events in response to the randomized intervention
Description
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)
Other Pre-specified Outcome Measures:
Title
Change in in vitro circadian parameters (amplitude and magnitude)
Description
As measured in cultured skin fibroblasts (in a subset of the study population)
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in metabolomic parameters
Description
As measured by high-throughput mass spectrometry metabolomics
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in lipid metabolism
Description
As measured by high-throughput mass spectrometry lipidomics
Time Frame
From randomization visit to close-out visit (12 weeks)
Title
Change in blood hormonal profile
Description
Cortisol, insulin, thyroid-stimulating hormone
Time Frame
From randomization visit to close-out visit (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tinh-Hai Collet, MD
Phone
+41-22-372.93.49
Email
tinh-hai.collet@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Biolley, BSc
Phone
+41-79-553.04.66
Email
emma.biolley@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tinh-Hai Collet, MD
Organizational Affiliation
Geneva University Hospitals, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tinh-Hai Collet, MD
First Name & Middle Initial & Last Name & Degree
Tinh-Hai Collet, MD
First Name & Middle Initial & Last Name & Degree
Charna Dibner, PhD
First Name & Middle Initial & Last Name & Degree
Laurence Genton, MD
First Name & Middle Initial & Last Name & Degree
Jardena Puder, MD
12. IPD Sharing Statement
Learn more about this trial
Time-restricted Eating in Morning Chronotype
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