Dietary Intervention to Mitigate Adverse Consequences of Night Work
- Conditions
- Dietary Habits
- Interventions
- Behavioral: dietary intervention
- Registration Number
- NCT04868526
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.)
- Currently smoking/vaping or 5 or more years of smoking/vaping
- History of drug or alcohol dependency
- History of psychiatric illness or disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Control-Dietary Intervention 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. Dietary intervention-Control dietary intervention 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.
- Primary Outcome Measures
Name Time Method Change in glucose tolerance from Baseline to Test Day 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 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 Outcome Measures
Name Time Method Change in levels of serum markers of gut microbiota from Baseline to Test Day 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.
Change in level of serum markers of inflammatory state from Baseline to Test Day 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.
Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day 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.
Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day 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.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States