Recruiting

Dietary Intervention

Sponsor:

Brigham and Women's Hospital

Code:

NCT04868526

Conditions

Dietary Habits

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

dietary intervention

Study Details

Brief summary:

The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.

Participants will:

  • complete 2 inpatient stays
  • be provided with identical meals
  • have frequent blood draws
  • provide urine, saliva, stool and rectal swab samples

Conditions

Dietary Habits

Study ID

NCT04868526

Start date

Mar 29, 2023

Status verified date

Nov, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-45 yr old
  • BMI 20.0-29.9
  • European/Hispanic/African-American ancestry
  • No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)

Exclusion Criteria:

  • Currently smoking/vaping or 5 or more years of smoking/vaping
  • History of drug or alcohol dependency
  • History of psychiatric illness or disorder

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Control-Dietary Intervention

Control condition first, then the Dietary intervention. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes.

experimental: Dietary intervention-Control

Dietary intervention first, then the Control condition. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage but will be made public once enrollment closes.

Interventions

dietary intervention

Research participants will be assigned to two dietary conditions.

Primary outcome measure

  • Change in glucose tolerance from Baseline to Test Day [ Time Frame: Baseline (Day 2) and Test Day (Day 4) ]
  • Changes in microbial community structure/composition/function of oral and gut microbiome from Baseline to Test Day [ Time Frame: Baseline (Day 2) and Test Day (Day 4) ]

Central Contacts and Locations

Central contacts

Megan Munn

6175258259mmunn@bwh.harvard.edu

Han-Chow Koh, PhD

6172780924hkoh@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Han-Chow Koh, PhD

6172780924

Principal Investigator:

Frank Scheer, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Dec 5, 2025

Last verified

Nov, 2025

Keywords

  • Night shift work
  • Glucose tolerance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-12-05.