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NCT Number: NCT05862818

Can Food Timing Reduce Your Diabetes Risk?

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

Recruiting

Interested in participating?

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Key information

Conditions

Dietary Habits Behavior Behavior, Animal Feeding Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Frank Scheer, PhD

CONTACT

[email protected]

617-732-14

Frank Scheer, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 - Diet order B-A

Behavioral

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

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 - Diet order B-A

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. Difference in plasma triglyceride level between Meal Conditions and Shift Work

    Time frame: 24 hours

    Triglyceride area under the curve (AUC) over 24 hours

Secondary outcomes

  1. Difference in insulin sensitivity between Meal Conditions and Shift Work

    Time frame: 24 hours

    Insulin sensitivity index derived from Oral Minimal Model

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

    Time frame: 24 hours

    Beta-cell function index derived from Oral Minimal Model

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ioannis Lempesis, MD, PhD, PhD

CONTACT

[email protected]

6177326256

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 17, 2023
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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