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Overweight and ObesityNCT04618133

Time-restricted Eating in Morning Chronotype

A study testing Early time-restricted eating and Late time-restricted eating in people with Overweight and Obesity, run by Tinh-Hai Collet, MD at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 50 years
Conditions the study is for
Overweight and Obesity
What is being tested?
Early time-restricted eating and Late time-restricted eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteSwitzerland
Study dates
4 Jan 2021to 22 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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...)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Geneva University Hospitals

    Geneva, 1211

Other trials in Switzerland

About this study

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

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.

Read more

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.

Being tested
Early time-restricted eating, Late time-restricted eating, Active control
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early time-restricted eatingBehavioural

    Also called Early TRE

    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

  • Late time-restricted eatingBehavioural

    Also called Late 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

  • Active controlBehavioural

    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

Study groups in NCT04618133
Study groupRoleWhat they receive
Early time-restricted eatingExperimentalDuration: 12 weeks
Receives: Behavioral: Early time-restricted eating
Late time-restricted eatingExperimentalDuration: 12 weeks
Receives: Behavioral: Late time-restricted eating
Active controlActive comparatorDuration: 12 weeks
Receives: Behavioral: Active control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body fat mass

    As measured by dual-energy x-rax absorptiometry (DXA)

    Measured: From randomization visit to close-out visit (12 weeks)

Secondary outcomes (18)

  1. Change in physical activity

    As measured by actigraphy

    Measured: From randomization visit to close-out visit (12 weeks)

  2. Change in sleep/wake cycles

    As measured by actigraphy

    Measured: From randomization visit to close-out visit (12 weeks)

  3. Change in ambient light

    As measured by actigraphy

    Measured: From randomization visit to close-out visit (12 weeks)

  4. 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)

    Measured: From randomization visit to close-out visit (12 weeks)

  5. Change in eating duration

    Duration from the first to last caloric intake over 24-hour cycle

    Measured: From randomization visit to close-out visit (12 weeks)

  6. Change in calorie intake over the 24-hour cycle

    Assessed by a 24-hour food recall

    Measured: From randomization visit to close-out visit (12 weeks)

  7. Change in weight

    Body weight (kg)

    Measured: From randomization visit to close-out visit (12 weeks)

  8. Change in waist circumference

    Waist circumference (cm) assessed with a measuring tape

    Measured: From randomization visit to close-out visit (12 weeks)

  9. Change in hip circumference

    Hip circumference (cm) assessed with a measuring tape

    Measured: From randomization visit to close-out visit (12 weeks)

  10. Change in systolic and diastolic blood pressure

    As measured with an arm cuff in the sitting position

    Measured: From randomization visit to close-out visit (12 weeks)

  11. Change in fasting glucose

    As measured in clinical chemistry

    Measured: From randomization visit to close-out visit (12 weeks)

  12. Change in lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol)

    As measured by clinical chemistry

    Measured: From randomization visit to close-out visit (12 weeks)

  13. Change in body fat mass

    As measured by bioelectrical impedance analysis (BIA)

    Measured: From randomization visit to close-out visit (12 weeks)

  14. Change in lean body mass

    As measured by dual-energy x-rax absorptiometry (DXA)

    Measured: From randomization visit to close-out visit (12 weeks)

  15. Change in fat-free mass

    As measured by bioelectrical impedance analysis (BIA)

    Measured: From randomization visit to close-out visit (12 weeks)

  16. Change in resting energy expenditure

    As measured by indirect calorimetry

    Measured: From randomization visit to close-out visit (12 weeks)

  17. Change in glucose excursion

    As measured by continuous glucose monitoring

    Measured: From randomization visit to close-out visit (12 weeks)

  18. Incidence of adverse events in response to the randomized intervention

    Adverse events graded after the Common Terminology Criteria for Adverse Events version 5.0

    Measured: From randomization visit to close-out visit (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2020
  2. Study start4 Jan 2021
  3. Primary completion15 Jul 2024
  4. Study completion22 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04618133
Sponsor's protocol ID
2020-01439
Status last verified
Dec 2024
First submitted
28 Oct 2020
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Early time-restricted eating and Late time-restricted eating in people with Overweight and Obesity, run by Tinh-Hai Collet, MD at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body fat mass (time frame: From randomization visit to close-out visit (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04618133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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