NCT Number: NCT04868526
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
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Frank Scheer, PhD
PRINCIPAL_INVESTIGATOR
Han-Chow Koh, PhD
CONTACT
Han-Chow Koh, PhD
SUB_INVESTIGATOR
Jingyi Qian, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Research participants will be assigned to two dietary conditions.
Time frame: Baseline (Day 2) and Test Day (Day 4)
Change in incremental glucose area under the curve (AUC) from a mixed meal test.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Han-Chow Koh, PhD
CONTACT
Megan Munn
CONTACT
Brigham and Women's Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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