Dietary Intervention to Mitigate Adverse Consequences of Night Work
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dietary Habits
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in glucose tolerance from Baseline to Test Day
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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
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.
Investigators
Frank AJL Scheer, PhD
Professor
Brigham and Women's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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
- Change in levels of serum markers of gut microbiota from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))
- Change in level of serum markers of inflammatory state from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))
- Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))
- Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day(Baseline (Day 2) and Test Day (Day 4))