Clinical trial NCT04618133: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 92
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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...)

Primary outcomes:
measure: Change in body fat mass
timeFrame: From randomization visit to close-out visit (12 weeks)
Secondary outcomes:
measure: Change in physical activity
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in sleep/wake cycles
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in ambient light
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in sleep quality
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in eating duration
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in calorie intake over the 24-hour cycle
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in weight
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in waist circumference
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in hip circumference
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in systolic and diastolic blood pressure
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in fasting glucose
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol)
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in body fat mass
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in lean body mass
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in fat-free mass
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in resting energy expenditure
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in glucose excursion
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Incidence of adverse events in response to the randomized intervention
timeFrame: From randomization visit to close-out visit (12 weeks)
Other outcomes:
measure: Change in in vitro circadian parameters (amplitude and magnitude)
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in metabolomic parameters
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in lipid metabolism
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Change in blood hormonal profile
timeFrame: From randomization visit to close-out visit (12 weeks)
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: Geneva University Hospitals, Geneva
name: Tinh-Hai Collet, MD
role: PRINCIPAL_INVESTIGATOR
References: