Dietary Habits
Conditions
Keywords
Night shift work, Glucose tolerance
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.
Interventions
BEHAVIORALdietary intervention
Research participants will be assigned to two dietary conditions.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
United States
Contacts
Primary ContactMegan Munn
Backup ContactHan-Chow Koh, PhD
Outcome results
None listed