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Completed

NCT Number: NCT04618133

Time-restricted Eating in Morning Chronotype

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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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

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

Other names: Early TRE

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

Other names: Late TRE

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tinh-Hai Collet, MD

Other

Registry information

Official study title

Time-restricted Eating to Improve Body Fat Mass in Overweight and Obese Individuals with Morning Chronotype: a Randomized, Open-label, Multi-arm Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2020
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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