Can Food Timing Reduce Your Diabetes Risk?

Dietary Habits Clinical Trial

Official title:

Can Food Timing Reduce Your Diabetes Risk?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05862818
• Other study ID #: 2023P001063
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2029

Study information

• Verified date: May 2023
• Source: Brigham and Women's Hospital
• Contact: Megan Munn
• Phone: 6175258259
• Email: mmunn[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy with no acute or chronic medical and psychiatric disorders

• BMI 25.0-34.9 kg/m2

Exclusion Criteria:

• Smokers, current tobacco or e-cigarette use

• Drug or alcohol dependency

• Pregnant

Related Conditions & MeSH terms

• Dietary Habits

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in glucose tolerance between Meal Conditions and Shift Work	Glucose incremental area under the curve (AUC) from mixed meal tests	24 hours
Primary	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
Primary	Difference in plasma triglyceride level between Meal Conditions and Shift Work	Triglyceride area under the curve (AUC) over 24 hours	24 hours
Secondary	Difference in insulin sensitivity between Meal Conditions and Shift Work	Insulin sensitivity index derived from Oral Minimal Model	24 hours
Secondary	Difference in beta-cell function between Meal Conditions and Shift Work	Beta-cell function index derived from Oral Minimal Model	24 hours
Secondary	Difference in 24-h glycemia between Meal Conditions and Shift Work	Glucose area under the curve (AUC) based on CGM over 24 hours	24 hours
Secondary	Difference in postprandial incretin level between Meal Conditions and Shift Work	Incretin incremental area under the curve (AUC) from mixed meal tests	24 hours
Secondary	Difference in substrate oxidation between Meal Conditions and Shift Work	Postprandial substrate oxidation incremental area under the curve (AUC) from mixed meal tests	24 hours
Secondary	Difference in plasma free fatty acids level between Meal Conditions and Shift Work	Free fatty acids area under the curve (AUC) over 24 hours	24 hours