This study is conducted by the Sleep and Chronobiology Laboratory at the University of Colorado at Boulder.

Navy Study Requirements: Healthy Men & Women Age 18-35

This study is about how sleep loss and being awake at night impacts your ability to think, changes molecules in your blood, and alters the bacteria that live in your gut, mouth and on your skin and typically help keep you healthy. We are testing how a prebiotic diet alters how you and the bacteria living in your gut respond to sleep loss and being awake at night. 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).

Prior to the start of this study, there are screening procedures to ensure you meet the criteria for the study. At your first consent screening appointment, you will learn more about the study, answer questionnaires, and complete a psychological interview. At your second medical screening appointment, you 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 your body uses at rest). We will also have you meet with a nutritionist to discuss your food preferences for the study. Although you are not financially compensated for the screening procedures, we do cover the expense of the screening tests. 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, you will complete two laboratory visits, both visits preceded by two weeks of home activity monitoring and ten days of continuous glucose monitoring. During your home monitoring, we ask you to wear a special watch that records your activity levels. We also ask you to keep a sleep/wake log and use a website to log your daily sleep/wake times (if you cannot access this website, you can call into our answering machine to inform us when you go to bed and wake up each day). You will also be provided a powdered prebiotic or maltodextrin placebo that we will ask you to consume once daily, mixed with water. Throughout the study you will be given both a prebiotic and a placebo, but the order of treatment is randomized. It is possible you may receive the prebiotic before the first laboratory visit and will consume that daily until receiving the placebo before the second laboratory visit. Otherwise you would receive the placebo before your first laboratory visit and will consume that daily until receiving the prebiotic before the second visit. We will provide you a pre-study diet prepared by our dieticians for you to eat for the three days prior to your laboratory visit. During the two weeks between your first and second laboratory visit we will ask you to continue to wear the special watch, keep a sleep/wake log, and use a website to log your daily sleep/wake times (or call them into our answering machine). Once again, for two weeks, you will be provided with either a prebiotic or placebo powder that will be incorporated once daily into water and then consumed. You will again be given a pre-study diet for the three days prior to your second visit.

During your laboratory visits, you will live in our 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, you will spend the night in the laboratory, sleeping your normal 8 hours. We will use this as a pre-study screening for problems with your sleep. In the morning you will complete some pre-study tests and samples which will take approximately 60 minutes. You will then be permitted to leave the laboratory and in the evening you will arrive to begin the study. During the study your sleep schedule will be changed to simulate the sleep loss that emergency workers in medical and military situations experience. You will be given an initial 3 hour sleep opportunity and then kept awake overnight. Throughout the study you will be given a 3 hour sleep opportunity for every 24 hours of the laboratory visit. While you are awake, we will ask you to perform a number of computer tasks, including a driving simulator. We will take blood and saliva samples to test for circadian and metabolic markers. We will also ask you to collect samples of the bacteria that live in your gastrointestinal tract from used bathroom tissue after you use the bathroom in the study. Finally, we will test how your heart and nervous system respond to stress by having you place your hand in an ice water bath. At the end of the laboratory visit you will be given an 11 hour sleep opportunity to recover from your sleep loss. After 3 more days of recovery sleep and another 2 weeks of home monitoring and daily prebiotic/placebo (identical to the first two weeks of the study), these procedures will be repeated in a second laboratory visit.

If you are eligible to participate in this study, you will be financially compensated for your involvement after the screening procedures. You will be compensated $75 for each week of home activity monitoring, $25 for each week of Continuous Glucose Monitoring, $232 for each 24h in the laboratory, $30 for transportation to or from the laboratory visits, and an additional $214 as a study completion bonus. The total compensation can be up to $2451.

If you are interested in applying to participate in this study, please complete this on-line application survey. We will contact you within one week to let you know if you qualify for the first consent screening appointment. If you need assistance with this survey, have additional questions about the study, or would like to complete the survey via the telephone, please contact us at (303) 735-1923 (M-F, 9am-5pm). With the email address of sleep.study@colorado.edu, general questions can also be answered.

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