Can Food Timing Reduce Your Diabetes Risk?

NCT05862818 | Recruiting

• 1 other identifier: 2023P001063
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

Glucose tolerance; Diet-induced thermogenesis; Fat tolerance

Outcome Measures

Primary Outcomes (3)

• Difference in glucose tolerance between Meal Conditions and Shift Work

  Glucose incremental area under the curve (AUC) from mixed meal tests

  24 hours

• Difference in diet-induced thermogenesis between Meal Conditions and Shift Work

  Postprandial energy expenditure incremental area under the curve (AUC) from mixed meal tests

  24 hours

• Difference in plasma triglyceride level between Meal Conditions and Shift Work

  Triglyceride area under the curve (AUC) over 24 hours

  24 hours

Secondary Outcomes (6)

• Difference in insulin sensitivity between Meal Conditions and Shift Work

  24 hours

• Difference in beta-cell function between Meal Conditions and Shift Work

  24 hours

• Difference in 24-h glycemia between Meal Conditions and Shift Work

  24 hours

• Difference in postprandial incretin level between Meal Conditions and Shift Work

  24 hours

• Difference in substrate oxidation between Meal Conditions and Shift Work

  24 hours

Study Arms (4)

Day shift protocol with diet A

EXPERIMENTAL

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.

Behavioral: Day shift protocol - Diet order A-B; Behavioral: Day shift protocol - Diet order B-A

Day shift protocol with diet B

EXPERIMENTAL

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.

Behavioral: Day shift protocol - Diet order A-B; Behavioral: Day shift protocol - Diet order B-A

Night shift protocol with diet A

EXPERIMENTAL

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.

Behavioral: Night shift protocol - Diet order A-B; Behavioral: Night shift protocol - Diet order B-A

Night shift protocol with diet B

EXPERIMENTAL

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.

Behavioral: Night shift protocol - Diet order A-B; Behavioral: Night shift protocol - Diet order B-A

Interventions

Day shift protocol - Diet order A-B BEHAVIORAL

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

Day shift protocol with diet A; Day shift protocol with diet B

Day shift protocol - Diet order B-A BEHAVIORAL

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

Day shift protocol with diet A; Day shift protocol with diet B

Night shift protocol - Diet order A-B BEHAVIORAL

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

Night shift protocol with diet A; Night shift protocol with diet B

Night shift protocol - Diet order B-A BEHAVIORAL

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

Night shift protocol with diet A; Night shift protocol with diet B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Frank Scheer, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioannis Lempesis, MD, PhD, PhD

CONTACT

6177326256; timedstudy@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 17, 2023
• Study Start: December 10, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)