Can Food Timing Reduce Your Diabetes Risk?

May 11, 2023 updated by: Frank AJL Scheer, PhD, Brigham and Women's Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Frank Scheer, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Day shift protocol - Diet order A-B
Research participants will be assigned to day shift condition and Diet A-B order condition.
Behavioral: Day shift protocol - Diet order B-A
Research participants will be assigned to day shift condition and Diet B-A order condition.
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.
Behavioral: Day shift protocol - Diet order A-B
Research participants will be assigned to day shift condition and Diet A-B order condition.
Behavioral: Day shift protocol - Diet order B-A
Research participants will be assigned to day shift condition and Diet B-A order condition.
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.
Behavioral: Night shift protocol - Diet order A-B
Research participants will be assigned to simulated night shift condition and Diet A-B order condition.
Behavioral: Night shift protocol - Diet order B-A
Research participants will be assigned to simulated night shift condition and Diet B-A order condition.
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.
Behavioral: Night shift protocol - Diet order A-B
Research participants will be assigned to simulated night shift condition and Diet A-B order condition.
Behavioral: Night shift protocol - Diet order B-A
Research participants will be assigned to simulated night shift condition and Diet B-A order condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in glucose tolerance between Meal Conditions and Shift Work
Time Frame: 24 hours
Glucose incremental area under the curve (AUC) from mixed meal tests
24 hours
Difference in diet-induced thermogenesis between Meal Conditions and Shift Work
Time Frame: 24 hours
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
Time Frame: 24 hours
Triglyceride area under the curve (AUC) over 24 hours
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Frank Scheer, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2024

Primary Completion (Anticipated)

April 1, 2029

Study Completion (Anticipated)

April 1, 2029

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023P001063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dietary Habits

Clinical Trials on Day shift protocol - Diet order A-B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe