Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT05862818

Conditions

Dietary Habits

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Day shift protocol - Diet order A-B

Day shift protocol - Diet order B-A

Night shift protocol - Diet order A-B

Night shift protocol - Diet order B-A

Study Details

Brief summary:

The goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants.

Participants will:

  • complete 2 inpatient stays
  • be provided with test meals
  • have frequent blood draws

Conditions

Dietary Habits

Study ID

NCT05862818

Start date

Dec 10, 2024

Status verified date

Aug, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy with no acute or chronic medical and psychiatric disorders
  • BMI: 18.5-29.9 kg/m2

Exclusion Criteria:

  • Smokers, current tobacco or e-cigarette use
  • Drug or alcohol dependency
  • Pregnant

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Day shift protocol with diet A

Day shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

experimental: Day shift protocol with diet B

Day shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

experimental: Night shift protocol with diet A

Night shift protocol with diet A condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

experimental: Night shift protocol with diet B

Night shift protocol with diet B condition. Since this is a single-blind study, the details of the meal conditions cannot be released during the recruitment stage but will be made public once enrollment closes.

Interventions

Day shift protocol - Diet order A-B

Research participants will be assigned to day shift condition and Diet A-B order condition.

Day shift protocol - Diet order B-A

Research participants will be assigned to day shift condition and Diet B-A order condition.

Night shift protocol - Diet order A-B

Research participants will be assigned to simulated night shift condition and Diet A-B order condition.

Night shift protocol - Diet order B-A

Research participants will be assigned to simulated night shift condition and Diet B-A order condition.

Primary outcome measure

  • Difference in glucose tolerance between Meal Conditions and Shift Work [ Time Frame: 24 hours ]
  • Difference in diet-induced thermogenesis between Meal Conditions and Shift Work [ Time Frame: 24 hours ]
  • Difference in plasma triglyceride level between Meal Conditions and Shift Work [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Ioannis Lempesis, MD, PhD, PhD

6177326256timedstudy@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Frank Scheer, PhD

617-732-14fscheer@bwh.harvard.edu

Principal Investigator:

Frank Scheer, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 6, 2025

Last verified

Aug, 2025

Keywords

  • Glucose tolerance
  • Diet-induced thermogenesis
  • Fat tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-08-06.