Dietary Intervention to Mitigate Adverse Consequences of Night Work

Dietary Habits Clinical Trial

Official title:

Dietary Intervention to Mitigate Adverse Consequences of Night Work

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868526
• Other study ID #: 2021P000683
• Secondary ID: R01HL153969
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: March 2023
• Source: Brigham and Women's Hospital
• Contact: Megan Munn
• Phone: 6175258259
• Email: mmunn[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Habits

Intervention

Behavioral:
• dietary intervention
Research participants will be assigned to two dietary conditions.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)