Dietary Intervention to Mitigate Adverse Consequences of Night Work

NCT ID: NCT04868526

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2026-09-01

Brief Summary

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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

Detailed Description

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Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.

Conditions

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Dietary Habits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

dietary intervention

Intervention Type BEHAVIORAL

Research participants will be assigned to two dietary conditions.

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.

Group Type EXPERIMENTAL

dietary intervention

Intervention Type BEHAVIORAL

Research participants will be assigned to two dietary conditions.

Interventions

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dietary intervention

Research participants will be assigned to two dietary conditions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frank AJL Scheer, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank Scheer, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Munn

Role: CONTACT

6175258259

Han-Chow Koh, PhD

Role: CONTACT

6172780924

Facility Contacts

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Han-Chow Koh, PhD

Role: primary

6172780924

Other Identifiers

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R01HL153969

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021P000683

Identifier Type: -

Identifier Source: org_study_id

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