Sleep DeprivationNCT03747367
The Microbiome and Resilience to Sleep and Circadian Disruption
A study testing Insufficient Sleep and Prebiotic in people with Sleep Deprivation and Circadian Dysregulation, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Circadian Dysregulation, Stress
- What is being tested?
- Insufficient Sleep and Prebiotic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2015to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Currently residing at Denver altitude or higher
Who cannot join
- Current major medical disorder
- Experiment 1 and 2, ages 18-35. Experiment 3 and 4, 18-45. Experiment 3 only: Early Morning Shift Workers Experiment 4 only: Individuals Receiving Less than 6.5 hours of Sleep At Night
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep and Chronobiology Laboratory
Boulder, Colorado, 80309-0554
About this study
Official title: 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).
Read the 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.
Experiment 3: Pre-biotic in Early Morning Shift Workers
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 and answer questionnaires. At the second medical screening appointment, participants will have a physical exam, blood work, drug screen, pregnancy test, electrocardiogram (a measurement of heart activity). 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 screening procedures, participants who are early morning shift workers (working at least 2 consecutive early morning (4-7am) work shifts), will complete an approximate 5 week study with the majority of research procedures being done at home. 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, then will come into the laboratory for a brief visit to have a fasting blood draw taken. After a minimum one week washout period with no data collection, 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 next in-laboratory visit where another fasting blood draw will be taken. 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 a PhD collaborator not involved with administration of the study protocol. Neither the investigators nor participants will know what is in the powder provided. During both two week data collection periods, participants will be outfitted with a continuous glucose monitor to be worn on the back of the arm, given an actiwatch to monitor activity and light levels to be worn on the wrist, and will be instructed to collect fecal samples at home and freeze these samples immediately. Additionally, for three days at home during both data collection periods, participants will be given an outpatient diet designed to meet caloric needs to control for food intake during fecal sampling periods. Finally, participants will be asked to fill out questionnaires related to their mood and sleep. Including screening appointments, there are a total of 8 visits required for this experiment.
Experiment 4: Pre-biotic in Individuals Receiving Insufficient Sleep
Similar to experiment 3, the majority of research procedures will be done at home following screening procedures. At the first consent screening appointment, participants will learn more about the study and answer questionnaires. Following screening procedures, participants who regularly receive less than 6.5 hours time in bed trying to sleep, will complete a 5 week study with the majority of research procedures being done at home. 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, then will come into the laboratory for a brief visit to have a fasting blood draw taken. After a one week washout period with no data collection, 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 next in-laboratory visit where another fasting blood draw will be taken. 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 a PhD collaborator not involved with administration of the study protocol. Neither the investigators nor participants will know what is in the powder provided. During both two week data collection periods, participants will be outfitted with a continuous glucose monitor to be worn on the back of the arm, given an actiwatch to monitor activity and light levels to be worn on the wrist, and will be instructed to collect fecal samples at home and freeze these samples immediately. Additionally, for three days at home during both data collection periods, participants will be asked to consume food similar to their normal food intake for 3 days and record this intake to control for food intake during fecal sampling periods. Finally, participants will be asked to fill out questionnaires related to their mood and sleep. Including screening appointments, there are a total of 5 visits required for this experiment.
- Conditions
- Sleep Deprivation, Circadian Dysregulation, Stress
- Being tested
- Insufficient Sleep, Prebiotic, Placebo
- Keywords
- Microbiome, Stress, Sleep, Circadian
- Medical subject headings
- Sleep Deprivation, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insufficient SleepBehavioural
PrebioticDietary supplement
Polydextrose and Galacto-oligosaccharide prebiotic supplement
PlaceboDietary supplement
Maltodextrin (placebo) supplement
| Study group | Role | What they receive |
|---|---|---|
| Experiment 1 and 2 Baseline | No intervention | 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. |
| Experiment 1 and 2 Insufficient Sleep | Experimental | 3 days with 3 hour sleep opportunities in lab, immediately following baseline on both visit 1 and visit 2. Receives: Behavioral: Insufficient Sleep |
| Experiment 3 and 4 Placebo | Placebo comparator | 14 days of placebo (Maltodextrin). 15g/day Receives: Dietary Supplement: Placebo |
| Experiment 3 and 4 Prebiotic | Active comparator | 14 days of Polydextrose and Galacto-oligosaccharides, 7.5g each/day Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal microbiome
Fecal "beta diversity" (unit=weighted UniFrac)
Measured: Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol). Experiment 3 and 4: Fecal samples taken at home, one from each condition (prebiotic and placebo)
Change in fecal metabolome
Fecal small molecules (Mass spect metabolite abundance)
Measured: Daily fecal samples while living in laboratory (3 samples per visit, 2 laboratory visits as part of a 39 day protocol). Experiment 3 and 4: Fecal samples taken at home, one from each condition (prebiotic and placebo)
Secondary outcomes (4)
Visual Search Performance
Cognitive Throughput (items/minute)
Measured: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol). N/A for experiment 3 and 4.
Maintenance of wakefulness test
Average latency to falling asleep (minutes)
Measured: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol). N/A for experiment 3 and 4.
Karolinska Sleepiness Scale
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.
Measured: Assessed every 3 hours daily while living in the laboratory (17 times per visit, 2 laboratory visits as part of a 39 day protocol). N/A for Experiment 3 and 4.
Changes in plasma metabolome
Plasma small molecules (Mass spect metabolite abundance)
Measured: Assessed ~every 6 hours while living in the laboratory (10 times per visit, 2 laboratory visits as part of a 39 day protocol). Experiment 3 and 4: Fasted blood samples taken once from each condition (prebiotic and placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start21 Oct 2015
- Primary completion12 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Experiment 1 - Single group, repeated assessment Experiment 2 - Double-blind, randomized, cross-over design Experiment 3 - Double-blind, randomized, cross-over design Experiment 4 - Double-blind, randomized, cross-over design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Office of Naval Research (ONR)
- Responsible party
- Principal investigator, Kenneth Wright, University of Colorado, Boulder
- Investigators
- Kenneth Wright, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747367
- Sponsor's protocol ID
- 15-0282
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2017
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbiome and Responsiveness to Stress: Countermeasure Strategies for Improving Resilience to Sleep and Circadian Disruption (Experiments 1 & 2)
- ClinicalTrials.gov ID
- NCT03747367
- Acronym / sponsor ID
- 15-0282
- Conditions
- Sleep Deprivation, Circadian Dysregulation, Stress
- Keywords
- Microbiome, Stress, Sleep, Circadian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- University of California, San Diego, Office of Naval Research (ONR)
- Study start
- 21 Oct 2015 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Experiment 3: Pre-biotic in Early Morning Shift Workers
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 and answer questionnaires. At the second medical screening appointment, participants will have a physical exam, blood work, drug screen, pregnancy test, electrocardiogram (a measurement of heart activity). 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 screening procedures, participants who are early morning shift workers (working at least 2 consecutive early morning (4-7am) work shifts), will complete an approximate 5 week study with the majority of research procedures being done at home. 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, then will come into the laboratory for a brief visit to have a fasting blood draw taken. After a minimum one week washout period with no data collection, 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 next in-laboratory visit where another fasting blood draw will be taken. 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 a PhD collaborator not involved with administration of the study protocol. Neither the investigators nor participants will know what is in the powder provided. During both two week data collection periods, participants will be outfitted with a continuous glucose monitor to be worn on the back of the arm, given an actiwatch to monitor activity and light levels to be worn on the wrist, and will be instructed to collect fecal samples at home and freeze these samples immediately. Additionally, for three days at home during both data collection periods, participants will be given an outpatient diet designed to meet caloric needs to control for food intake during fecal sampling periods. Finally, participants will be asked to fill out questionnaires related to their mood and sleep. Including screening appointments, there are a total of 8 visits required for this experiment.
Experiment 4: Pre-biotic in Individuals Receiving Insufficient Sleep
Similar to experiment 3, the majority of research procedures will be done at home following screening procedures. At the first consent screening appointment, participants will learn more about the study and answer questionnaires. Following screening procedures, participants who regularly receive less than 6.5 hours time in bed trying to sleep, will complete a 5 week study with the majority of research procedures being done at home. 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, then will come into the laboratory for a brief visit to have a fasting blood draw taken. After a one week washout period with no data collection, 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 next in-laboratory visit where another fasting blood draw will be taken. 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 a PhD collaborator not involved with administration of the study protocol. Neither the investigators nor participants will know what is in the powder provided. During both two week data collection periods, participants will be outfitted with a continuous glucose monitor to be worn on the back of the arm, given an actiwatch to monitor activity and light levels to be worn on the wrist, and will be instructed to collect fecal samples at home and freeze these samples immediately. Additionally, for three days at home during both data collection periods, participants will be asked to consume food similar to their normal food intake for 3 days and record this intake to control for food intake during fecal sampling periods. Finally, participants will be asked to fill out questionnaires related to their mood and sleep. Including screening appointments, there are a total of 5 visits required for this experiment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Experiment 1 - Single group, repeated assessment Experiment 2 - Double-blind, randomized, cross-over design Experiment 3 - Double-blind, randomized, cross-over design Experiment 4 - Double-blind, randomized, cross-over design
| Arm | Type | Receives |
|---|---|---|
| Experiment 1 and 2 Baseline | No intervention | –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. |
| Experiment 1 and 2 Insufficient Sleep | Experimental | Behavioral: Insufficient Sleep3 days with 3 hour sleep opportunities in lab, immediately following baseline on both visit 1 and visit 2. |
| Experiment 3 and 4 Placebo | Placebo comparator | Dietary Supplement: Placebo14 days of placebo (Maltodextrin). 15g/day |
| Experiment 3 and 4 Prebiotic | Active comparator | Dietary Supplement: Prebiotic14 days of Polydextrose and Galacto-oligosaccharides, 7.5g each/day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Currently residing at Denver altitude or higher
Key exclusion criteria (2 listed)
- Current major medical disorder
- Experiment 1 and 2, ages 18-35. Experiment 3 and 4, 18-45. Experiment 3 only: Early Morning Shift Workers Experiment 4 only: Individuals Receiving Less than 6.5 hours of Sleep At Night
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insufficient Sleep | Behavioural | Experiment 1 and 2 Insufficient Sleep |
| PrebioticPolydextrose and Galacto-oligosaccharide prebiotic supplement | Dietary supplement | Experiment 3 and 4 Prebiotic |
| PlaceboMaltodextrin (placebo) supplement | Dietary supplement | Experiment 3 and 4 Placebo |
Primary outcome
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). Experiment 3 and 4: Fecal samples taken at home, one from each condition (prebiotic and placebo)
Fecal "beta diversity" (unit=weighted UniFrac)
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). Experiment 3 and 4: Fecal samples taken at home, one from each condition (prebiotic and placebo)
Fecal small molecules (Mass spect metabolite abundance)
4 secondary outcomes
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). N/A for experiment 3 and 4.
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). N/A for experiment 3 and 4.
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). N/A for Experiment 3 and 4.
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). Experiment 3 and 4: Fasted blood samples taken once from each condition (prebiotic and placebo)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Wright, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insufficient Sleep and Prebiotic in people with Sleep Deprivation and Circadian Dysregulation, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). Experiment 3 and 4: Fecal samples taken at home, one from each condition (prebiotic and placebo)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.