SleepNCT07243574
Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota
A study testing Increase sleep by 90 minutes and Decrease sleep by 90 minutes in people with Sleep, run by Danisco at 3 sites in United States.
Trial summary
The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Increase sleep by 90 minutes and Decrease sleep by 90 minutes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Sep 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
- Consistent schedule during daytime hours.
- BMI 18.5 - 35 kg/m2 (inclusive).
- Good physical and mental health as established by self-reported medical history.
- Willingness to maintain and record their general habits, eating, and activity/exercise pattern for the study period.
- Willingness to maintain and record the same time in bed they have during the workdays throughout the habitual workday sleep period.
Show all 22Show fewer
- Able to alter sleeping time during the study intervention period as instructed.
- Willingness to maintain typical sleep hygiene patterns (e.g. sleep location, temperature, environment).
- Willingness to maintain their current pattern of alcohol consumption for the duration of the study.
- Willing and able to participate fully in all aspects of the study and complete all study procedures, including providing signed informed consent.
- Completes all study procedures during the 14-day screening period to be eligible for the cohort specific criteria based on the sleep data collected during the screening period.
- Has regular bowel habits with bowel movements on at least 5 days a week.
- Pittsburgh Sleep Quality Index (PSQI) score ≤10. Note: If PSQI score is between 8 and 10, PI discretion needed to confirm eligibility based on self-report screening diaries and health \& lifestyle questionnaire.
- Cohort specific inclusion criteria:
- Cohort 1 (Insufficient Sleep)
- Participants must meet all general inclusion criteria PLUS:
- Sleep, on average, 5-7 hours per night on workdays, verified via participant self report during the screening period. Note: Oura ring data from the run-in period will be reviewed to confirm cohort based on PI/Sponsor discretion.
- Average KSS Score of 6-10 on workdays during the screening period. Note: Use standard rounding rules for averages with decimal places.
- Cohort 2 (Sufficient Sleep)
- Participants must meet all general inclusion criteria PLUS:
- Sleep, on average, 7-9 hours per night on workdays, verified via participant self-report during the screening period. Note: Oura ring data from the run-in period will be reviewed to confirm cohort based on PI/Sponsor discretion.
- Average KSS Score of 1-5 on workdays during screening period. Note: Use standard rounding rules for averages with decimal places.
Who cannot join
- Any current diagnosed or self-reported sleep disorder, including but not limited to sleep apnea, habitual snoring (defined as loud, persistent snoring 3 or more nights per week), insomnia, narcolepsy, and parasomnias.
- Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heart burn.
- Regularly wakes up during the night 5 or more times per night for a cumulative amount of 30 minutes as observed via self-report during the screening period, per Principal Investigator (PI) discretion.
- Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
- Have taken in the last 3 months medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
- Neurodegenerative diseases (including multiple sclerosis, Parkinson's disease, Alzheimer's disease, dementia).
Show all 23Show fewer
- Recent history (current use or within the past 1 month) of smoking, vaping or other use of nicotine-containing products.
- Recent history (past year) of alcohol abuse or dependence. Defined as regularly drinking more than 12 drinks for females and more than 20 drinks for males per week and based on PI discretion.
- Drug abuse or dependence, including consistent recreational substance use such as marijuana.
- Binge drinking behavior, defined as 4 or more alcoholic drinks for women or 5 or more alcoholic drinks for men in one sitting on 2 or more occasions, within the past 1 month with final decision per PI discretion.
- Diagnosed neuropsychiatric disorders or symptoms possibly affecting sleep (generalized anxiety disorder (GAD), major depressive disorder (MDD), bipolar disorder, schizophrenia)
- Any use of systemic antibiotics in the past 3 months. Topical or targeted antibiotic use (eye drop, ear drop) are allowed.
- Any use of probiotic supplements in the past 2 weeks.
- Any use of proton pump inhibitors (PPIs) in the past 2 weeks.
- Pregnant or breastfeeding or planning to become pregnant.
- Personal life situation causing stress or challenges in sleep (eg. caretaker required to wake up during sleep, major change in personal life). Note: Life situations causing stress or challenges in sleep that are considered short-term, per PI discretion, may be considered for re-screening 4 weeks after the life situation has resolved, meaning it is no longer causing stress or challenges in sleep.
- Planned overnight or cross time zone travel during the study.
- Females experiencing perimenopausal or menopausal symptoms, or those who have been diagnosed as perimenopausal or menopausal by a physician.
- Any diagnosed condition or undiagnosed symptom which disrupts sleep, including, but not limited to, hyperthyroidism, night sweats, restless legs, or poorly controlled allergic rhinitis.
- Extreme chronotypes for Cohort 2 (Sufficient Sleep); those that regularly go to sleep prior to 08:00 pm or after 2:30 am on 3 or more nights a week.
- Extreme chronotypes for Cohort 1 (Insufficient Sleep); those that regularly go to sleep prior to 08:00 pm on 3 or more nights a week.
- Varying work schedule and/or shift workers who work overnight shifts (e.g. 3rd shift, working late night to early morning hours)
- Any other personal or medical condition that the investigator believes may bias or confound the results.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lindus Health
Boston, Massachusetts, 02111
AccuMed
Garden City, New York, 11530
Global Life Research Network
Miami, Florida, 33155
About this study
The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles.
Researchers will compare the effect of sleep intervention on both insufficient and sufficient sleepers to identify differences in fecal microbiota structure and function between cohorts during habitual sleep and during the sleep alteration intervention period..
Participants will be assigned to one of two cohorts based on their current sleep habits. Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. The sleep intervention lasts for 14 days.
- Conditions
- Sleep
- Being tested
- Increase sleep by 90 minutes, Decrease sleep by 90 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase sleep by 90 minutesBehavioural
For 14 days, participants will increase their nightly sleep by 90 minutes.
Decrease sleep by 90 minutesBehavioural
For 14 days, participants will decrease their nightly sleep by 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Receives: Behavioral: Increase sleep by 90 minutes |
| Cohort 2 | Active comparator | Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. Receives: Behavioral: Decrease sleep by 90 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the fecal microbiota of individuals with sufficient and insufficient sleep.
Measure changes in microbial abundance and diversity from baseline to the end of the study in those individuals who have sufficient sleep compared to those with insufficient sleep. This is comparing the sufficient sleep group to the insufficient sleep group across all study periods.
Measured: From Day 1 to Day 28
To evaluate the response of the microbiota to changes in participant sleep duration.
Measure changes in gut microbiota within the individual during times of sufficient sleep compared to when they are getting insufficient sleep.This is measuring the change within individual participants before the intervention and after.
Measured: From Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start17 Sep 2025
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243574
- Sponsor's protocol ID
- IFF-NO-001
- Status last verified
- Nov 2025
- First submitted
- 17 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota
- ClinicalTrials.gov ID
- NCT07243574
- Acronym / sponsor ID
- IFF-NO-001
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Nov 2025 (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.
The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles.
Researchers will compare the effect of sleep intervention on both insufficient and sufficient sleepers to identify differences in fecal microbiota structure and function between cohorts during habitual sleep and during the sleep alteration intervention period..
Participants will be assigned to one of two cohorts based on their current sleep habits. Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. The sleep intervention lasts for 14 days.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Behavioral: Increase sleep by 90 minutesCohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. |
| Cohort 2 | Active comparator | Behavioral: Decrease sleep by 90 minutesCohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
- Consistent schedule during daytime hours.
- BMI 18.5 - 35 kg/m2 (inclusive).
- Good physical and mental health as established by self-reported medical history.
- Willingness to maintain and record their general habits, eating, and activity/exercise pattern for the study period.
Key exclusion criteria (23 listed)
- Any current diagnosed or self-reported sleep disorder, including but not limited to sleep apnea, habitual snoring (defined as loud, persistent snoring 3 or more nights per week), insomnia, narcolepsy, and parasomnias.
- Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heart burn.
- Regularly wakes up during the night 5 or more times per night for a cumulative amount of 30 minutes as observed via self-report during the screening period, per Principal Investigator (PI) discretion.
- Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
- Have taken in the last 3 months medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
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 |
|---|---|---|
| Increase sleep by 90 minutesFor 14 days, participants will increase their nightly sleep by 90 minutes. | Behavioural | Cohort 1 |
| Decrease sleep by 90 minutesFor 14 days, participants will decrease their nightly sleep by 90 minutes. | Behavioural | Cohort 2 |
Primary outcome
Differences in the fecal microbiota of individuals with sufficient and insufficient sleep.
Time frame: From Day 1 to Day 28
Measure changes in microbial abundance and diversity from baseline to the end of the study in those individuals who have sufficient sleep compared to those with insufficient sleep. This is comparing the sufficient sleep group to the insufficient sleep group across all study periods.
To evaluate the response of the microbiota to changes in participant sleep duration.
Time frame: From Day 1 to Day 28
Measure changes in gut microbiota within the individual during times of sufficient sleep compared to when they are getting insufficient sleep.This is measuring the change within individual participants before the intervention and after.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase sleep by 90 minutes and Decrease sleep by 90 minutes in people with Sleep, run by Danisco at 3 sites 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 22 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Differences in the fecal microbiota of individuals with sufficient and insufficient sleep. (time frame: From Day 1 to Day 28). 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 15 Oct 2026.