The Microbiome and Resilience to Sleep and Circadian Disruption
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 11/22/2018 |
| Start Date: | October 21, 2015 |
| End Date: | September 2020 |
| Contact: | Sleep and Chronobiology Laboratory |
| Email: | sleep.study@colorado.edu |
| Phone: | 303 735 1923 |
The Microbiome and Responsiveness to Stress: Countermeasure Strategies for Improving Resilience to Sleep and Circadian Disruption (Experiments 1 & 2)
This study is about how sleep loss and being awake at night impacts the ability to think,
changes molecules in the blood, and alters the bacteria that live in the gut that typically
help keep people healthy. This work will have important implications for the development of
treatments and countermeasures for people who do not sleep enough and need to be active at
different times of the day and night (e.g., emergency workers and military personnel).
changes molecules in the blood, and alters the bacteria that live in the gut that typically
help keep people healthy. This work will have important implications for the development of
treatments and countermeasures for people who do not sleep enough and need to be active at
different times of the day and night (e.g., emergency workers and military personnel).
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.
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.
Inclusion Criteria:
- Healthy
- Currently residing at Denver altitude or higher
Exclusion Criteria:
- Current major medical disorder
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