Can Food Timing Reduce Your Diabetes Risk?

Not Applicable

Recruiting

• Conditions: Dietary Habits
• Interventions: Behavioral: Day shift protocol - Diet order A-B; Behavioral: Night shift protocol - Diet order A-B; Behavioral: Day shift protocol - Diet order B-A; Behavioral: Night shift protocol - Diet order B-A

• Registration Number: NCT05862818
• Lead Sponsor: Brigham and Women's Hospital

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

Detailed Description

The investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-17
• Study Start: 2024-12-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Day shift protocol with diet B	Day shift protocol - Diet order A-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.
Day shift protocol with diet A	Day shift protocol - Diet order B-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.
Day shift protocol with diet A	Day shift protocol - Diet order A-B	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.
Night shift protocol with diet A	Night shift protocol - Diet order A-B	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.
Day shift protocol with diet B	Day shift protocol - Diet order B-A	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.
Night shift protocol with diet A	Night shift protocol - Diet order B-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.
Night shift protocol with diet B	Night shift protocol - Diet order A-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.
Night shift protocol with diet B	Night shift protocol - Diet order B-A	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.

Primary Outcome Measures

Name	Time	Method
Difference in diet-induced thermogenesis between Meal Conditions and Shift Work	24 hours	Postprandial energy expenditure incremental area under the curve (AUC) from mixed meal tests
Difference in plasma triglyceride level between Meal Conditions and Shift Work	24 hours	Triglyceride area under the curve (AUC) over 24 hours
Difference in glucose tolerance between Meal Conditions and Shift Work	24 hours	Glucose incremental area under the curve (AUC) from mixed meal tests

Secondary Outcome Measures

Name	Time	Method
Difference in postprandial incretin level between Meal Conditions and Shift Work	24 hours	Incretin incremental area under the curve (AUC) from mixed meal tests
Difference in insulin sensitivity between Meal Conditions and Shift Work	24 hours	Insulin sensitivity index derived from Oral Minimal Model
Difference in beta-cell function between Meal Conditions and Shift Work	24 hours	Beta-cell function index derived from Oral Minimal Model
Difference in 24-h glycemia between Meal Conditions and Shift Work	24 hours	Glucose area under the curve (AUC) based on CGM over 24 hours
Difference in plasma free fatty acids level between Meal Conditions and Shift Work	24 hours	Free fatty acids area under the curve (AUC) over 24 hours
Difference in substrate oxidation between Meal Conditions and Shift Work	24 hours	Postprandial substrate oxidation incremental area under the curve (AUC) from mixed meal tests

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States