- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03747367
The Microbiome and Resilience to Sleep and Circadian Disruption
The Microbiome and Responsiveness to Stress: Countermeasure Strategies for Improving Resilience to Sleep and Circadian Disruption (Experiments 1 & 2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Experiment 1: Consistency of microbiota-gut-brain axis responses
Prior to the start of this study, there are screening procedures to ensure participants meet the criteria for the study. At the first consent screening appointment, participants will learn more about the study, answer questionnaires, and complete a psychological interview. At the second medical screening appointment, participants will have a physical exam, blood work, drug screen, pregnancy test, electrocardiogram (a measurement of heart activity), and a resting metabolic rate assessment (a measurement of how much energy the body uses at rest). Participants will also meet with a nutritionist to discuss their food preferences for the study. Although participants are not financially compensated for the screening procedures, the expense of the screening tests is covered and copies are provided to the participant upon request. All of the results of the screening procedures are confidential and will only be used by the study staff to determine eligibility for the study.
Following the screening procedures, participants will complete two laboratory visits, both visits preceded by two weeks of home activity monitoring. During the home monitoring, participants wear a special watch that records activity levels. Participants also keep a sleep/wake log and use a website to log their daily sleep/wake times (if participants cannot access this website, they can call into an answering machine to inform investigators when they go to bed and wake up each day). The investigators will provide participants with a pre-study diet prepared by study dieticians for participants to eat for the three days prior to the laboratory visit. During the two weeks between the first and second laboratory visit participants will continue to wear the special watch, keep a sleep/wake log, and use a website to log their daily sleep/wake times (or call them into the answering machine). Participants will again be given a pre-study diet for the three days prior to their second visit.
During the laboratory visits, participants will live in the Sleep and Chronobiology Lab at the University of Colorado at Boulder for 3.7 days on two different occasions. The day before the inpatient visit begins, participants will spend the night in the laboratory, sleeping their normal 8 hours. This will be used as a pre-study screening for problems with sleep. In the morning participants will complete some pre-study tests and samples which will take approximately 60 minutes. Participants will then be permitted to leave the laboratory and in the evening they will return to begin the study. During the study participants sleep schedule will be changed to simulate the sleep loss that emergency workers in medical and military situations experience. Participants will be given an initial 3 hour sleep opportunity and then kept awake overnight. Throughout the study participants will be given a 3 hour sleep opportunity for every 24 hours of the laboratory visit. While participants are awake, they will be asked to perform a number of computer tasks, including a driving simulator. Blood and saliva samples will be taken to test for circadian and metabolic markers. Participants will also be asked to collect samples of the bacteria that live in their gastrointestinal tract from used bathroom tissue after they use the bathroom in the study. Finally, investigators will test how the heart and nervous system respond to stress by having participants place their hand in an ice water bath. At the end of the laboratory visit participants will be given an 11 hour sleep opportunity to recover from their sleep loss. After 3 more days of recovery sleep and another 2 weeks of home monitoring (identical to the first two weeks of the study), these procedures will be repeated in a second laboratory visit.
Experiment 2: Pre-biotic
Methods for experiment 2 are exactly the same as experiment 1 with the following addition: During the two weeks prior to laboratory visits, half of the study participants will be randomized (e.g., flip of a coin) to receive the prebiotic combination of polydextrose (PDX) and galacto-oligosaccharides (GOS) daily for 2 weeks and then tested in the first in-laboratory visit. These participants will then receive a maltodextrin placebo (a starch-derived food additive commonly used as a filling agent in a range of commercial foods and beverages) the two weeks prior to the second in-laboratory visit. The other half of participants will first receive maltodextrin and then the prebiotic diet. Investigators will provide participants the prebiotics and maltodextrin powders to be mixed in water and consumed each morning. The order in which participants receive the prebiotic diet will be maintained by the Clinical and Translational Research Center pharmacist. Neither the investigators nor participants will know what is in the powder provided.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sleep and Chronobiology Laboratory
- Phone Number: 303 735 1923
- Email: sleep.study@colorado.edu
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80309-0554
- Recruiting
- Sleep and Chronobiology Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Currently residing at Denver altitude or higher
Exclusion Criteria:
- Current major medical disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Baseline
8 hour sleep opportunity at habitual sleep/wake times for 14 days at home and 1 day in lab.
Repeated for visit 1 and visit 2.
|
|
Experimental: Insufficient Sleep
3 days with 3 hour sleep opportunities in lab, immediately following baseline on both visit 1 and visit 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fecal microbiome
Time Frame: Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol)
|
Fecal "beta diversity" (unit=weighted UniFrac)
|
Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol)
|
Change in fecal metabolome
Time Frame: Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol)
|
Fecal small molecules (Mass spect metabolite abundance)
|
Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Search Performance
Time Frame: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Cognitive Throughput (items/minute)
|
Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Maintenance of wakefulness test
Time Frame: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Average latency to falling asleep (minutes)
|
Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Karolinska Sleepiness Scale
Time Frame: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Single question likert scale: Total score reported with a range of 1-9; min score=1[very alert], maximum score=9[very sleepy, great effort to keep awake, fighting sleep].
A higher score representing higher sleepiness.
A lower score represents less sleepiness and a better outcome.
|
Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Changes in plasma metabolome
Time Frame: Assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Plasma small molecules (Mass spect metabolite abundance)
|
Assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kenneth Wright, PhD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Any data generated from the proposed work that is presented in a peer reviewed journal will be de-identified.
Microbiome data will be deposited in the International Nucleotide Sequence Database Collaboration www.insdc.org/ and is already deposited in Qiita http://qiita.microbio.me
Metabolomics data will be deposited in Global Natural Products Social (GNPS) molecular networking http://gnps.ucsd.edu
Other data that is presented in a peer reviewed journal will be archived indefinitely and made available upon request.
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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