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

Study Overview

• Status: Recruiting
• Conditions: Dietary Habits
• Intervention / Treatment: Behavioral: dietary intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Munn; Phone Number: 6175258259; Email: mmunn@bwh.harvard.edu
• Study Contact Backup: Name: Han-Chow Koh, PhD; Phone Number: 6172780924; Email: hkoh@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Principal Investigator: Frank Scheer, PhD
      • Sub-Investigator: Han-Chow Koh, PhD
      • Sub-Investigator: Jingyi Qian, PhD
      • Contact: Han-Chow Koh, PhD; Phone Number: 6172780924

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: dietary intervention; Research participants will be assigned to two dietary conditions.
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.	Behavioral: dietary intervention; Research participants will be assigned to two dietary conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day	Oral Minimal Model method estimates insulin sensitivity based on blood glucose and insulin levels from a mixed meal test.	Baseline (Day 2) and Test Day (Day 4)
Change in levels of serum markers of gut microbiota from Baseline to Test Day	Levels of markers of gut microbiota (e.g. short chain fatty acids) will be measured in serum samples taken 3-hourly over 24 hr.	Baseline (Day 2) and Test Day (Day 4)
Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day	Levels of markers of intestinal barrier integrity (e.g. zonulin, LPS, LBP) will be measured in serum samples taken 3-hourly over 24 hr.	Baseline (Day 2) and Test Day (Day 4)
Change in level of serum markers of inflammatory state from Baseline to Test Day	Levels of markers of inflammatory state (e.g., cytokines) will be measured in serum samples taken 3-hourly over 24 hr.	Baseline (Day 2) and Test Day (Day 4)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Frank Scheer, PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Glucose tolerance; Night shift work
• Additional Relevant MeSH Terms: Behavior; Behavior, Animal; Feeding Behavior; Therapeutics; Nutrition Therapy; Diet Therapy
• Other Study ID Numbers: 2021P000683; R01HL153969 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No