Time-restricted Eating in Morning Chronotype

NCT04618133 | Completed

• 1 other identifier: 2020-01439
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body fat mass

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

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

Secondary Outcomes (18)

• Change in physical activity

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

• Change in sleep/wake cycles

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

• Change in ambient light

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

• Change in sleep quality

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

• Change in eating duration

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

Other Outcomes (4)

• Change in in vitro circadian parameters (amplitude and magnitude)

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

• Change in metabolomic parameters

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

• Change in lipid metabolism

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

Study Arms (3)

Early time-restricted eating

EXPERIMENTAL

Duration: 12 weeks

Behavioral: Early time-restricted eating

Late time-restricted eating

EXPERIMENTAL

Duration: 12 weeks

Behavioral: Late time-restricted eating

Active control

ACTIVE COMPARATOR

Duration: 12 weeks

Behavioral: Active control

Interventions

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

Also known as: Early TRE

Early time-restricted eating

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

Also known as: Late TRE

Late time-restricted eating

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

Active control

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tinh-Hai Collet, MD: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Tinh-Hai Collet, MD

  Geneva University Hospitals, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 5, 2020
• Study Start: January 4, 2021
• Primary Completion: July 15, 2024
• Study Completion: October 22, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CH (1)