Dietary Intervention to Mitigate Adverse Consequences of Night Work

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Intervention to Mitigate Adverse Consequences of Night Work

Conditions
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Dietary Habits

Intervention / Treatment
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* Behavioral: dietary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control-Dietary Intervention<br>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<br>* Research participants will be assigned to two dietary conditions.<br>|
| Experimental: Dietary intervention-Control<br>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<br>* Research participants will be assigned to two dietary conditions.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Night shift work, Glucose tolerance