Dietary Intervention to Mitigate Adverse Consequences of Night Work
ConditionDietary Habits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorBrigham and Women's Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.)
Disqualifiers
Currently smoking/vaping or 5 or more years of smoking/vaping
History of drug or alcohol dependency
History of psychiatric illness or disorder
Trial design
Design model
Crossover
Treatments tested in this trial
dietary intervention
BehavioralResearch participants will be assigned to two dietary conditions.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Control-Dietary InterventionExperimental treatment 1 intervention
Group B: Dietary intervention-ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in glucose tolerance from Baseline to Test Day
Change in incremental glucose area under the curve (AUC) from a mixed meal test.
Time frame
Baseline (Day 2) and Test Day (Day 4)2
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.
Time frame
Baseline (Day 2) and Test Day (Day 4)Secondary outcomes
1
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.
Time frame
Baseline (Day 2) and Test Day (Day 4)2
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.
Time frame
Baseline (Day 2) and Test Day (Day 4)3
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.
Time frame
Baseline (Day 2) and Test Day (Day 4)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.
Time frame
Baseline (Day 2) and Test Day (Day 4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov