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NCT Number: NCT04868526

Dietary Intervention to Mitigate Adverse Consequences of Night Work

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Dietary intervention

Behavioral

Research participants will be assigned to two dietary conditions.

Primary outcomes

  1. Change in glucose tolerance from Baseline to Test Day

    Time frame: Baseline (Day 2) and Test Day (Day 4)

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

  2. 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)

    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.

Secondary outcomes

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

    Time frame: Baseline (Day 2) and Test Day (Day 4)

    Oral Minimal Model method estimates insulin sensitivity based on blood glucose and insulin levels from a mixed meal test.

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

    Time frame: Baseline (Day 2) and Test Day (Day 4)

    Levels of markers of gut microbiota (e.g. short chain fatty acids) will be measured in serum samples taken 3-hourly over 24 hr.

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

    Time frame: Baseline (Day 2) and Test Day (Day 4)

    Levels of markers of intestinal barrier integrity (e.g. zonulin, LPS, LBP) will be measured in serum samples taken 3-hourly over 24 hr.

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

    Time frame: Baseline (Day 2) and Test Day (Day 4)

    Levels of markers of inflammatory state (e.g., cytokines) will be measured in serum samples taken 3-hourly over 24 hr.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2021
Registry last updated
Dec 5, 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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