NCT04868526

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2023Sep 2026

First Submitted

Initial submission to the registry

April 23, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 29, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

3.4 years

First QC Date

April 23, 2021

Last Update Submit

November 28, 2025

Conditions

Dietary Habits

Keywords

Night shift workGlucose tolerance

Outcome Measures

Primary Outcomes (2)

  • Change in glucose tolerance from Baseline to Test Day

    Change in incremental glucose area under the curve (AUC) from a mixed meal test.

    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

    Shotgun metagenomics sequencing or 16S rRNA sequencing of saliva, stool, and rectal swab samples will provide in-depth interrogation of the microbial community structure, composition, and function.

    Baseline (Day 2) and Test Day (Day 4)

Secondary Outcomes (4)

  • Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day

    Baseline (Day 2) and Test Day (Day 4)

  • Change in levels of serum markers of gut microbiota from Baseline to Test Day

    Baseline (Day 2) and Test Day (Day 4)

  • Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day

    Baseline (Day 2) and Test Day (Day 4)

  • Change in level of serum markers of inflammatory state from Baseline to Test Day

    Baseline (Day 2) and Test Day (Day 4)

Study Arms (2)

Control-Dietary Intervention

EXPERIMENTAL

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.

Behavioral: dietary intervention

Dietary intervention-Control

EXPERIMENTAL

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.

Behavioral: dietary intervention

Interventions

dietary interventionBEHAVIORAL

Research participants will be assigned to two dietary conditions.

Control-Dietary InterventionDietary intervention-Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Frank Scheer, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Munn

CONTACT

6175258259mmunn@bwh.harvard.edu

Han-Chow Koh, PhD

CONTACT

6172780924hkoh@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 3, 2021

Study Start

March 29, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)