Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID04868526

Dietary Intervention to Mitigate Adverse Consequences of Night Work

Led by Brigham and Women's Hospital · Updated on 2025-12-05

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether a specific dietary intervention can prevent or reduce the negative health consequences of night shift work in healthy adults aged 18 to 45 years. The study focuses on the metabolic effects caused by circadian misalignment due to shift work, which may increase diabetes risk. Researchers hope to develop tailored dietary strategies to support metabolic health for shift workers. Participants will undergo two inpatient stays during which they will receive identical meals under two different dietary conditions. The study uses a randomized, single-blind design where participants receive either the control diet first followed by the dietary intervention, or vice versa. Details of the dietary intervention are kept confidential during the recruitment phase and will be disclosed after enrollment closes. Throughout the study, participants will provide frequent blood samples and various biological specimens including urine, saliva, stool, and rectal swabs. Researchers will measure changes in glucose tolerance and gut and oral microbiome profiles from baseline to test days. Additional assessments include insulin sensitivity and markers related to gut microbiota, intestinal barrier integrity, and inflammation. These evaluations help determine the intervention's impact on metabolic health during night shift conditions.

CONDITIONS

Brief Title

Dietary Intervention to Mitigate Adverse Consequences of Night Work

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 45 years
  • Body mass index (BMI) between 20.0 and 29.9
  • European, Hispanic, or African-American ancestry
  • No acute, chronic, or debilitating medical conditions such as metabolic, cardiovascular, respiratory, neurological diseases, or cancers
Not Eligible

You will not qualify if you...

  • Current smoking or vaping, or history of smoking/vaping for 5 or more years
  • History of drug or alcohol dependency
  • History of psychiatric illness or disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Several days per dietary condition

Participants undergo two dietary conditions in a crossover design to assess metabolic responses to shift work. Each dietary condition includes baseline and test day assessments.

1 baseline visit and 1 test day visit per dietary condition

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

M

Megan Munn

H

Han-Chow Koh, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Frequently Asked Questions

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