Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota

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 Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Increase sleep by 90 minutes; Behavioral: Decrease sleep by 90 minutes

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Not yet recruiting
      • Global Life Research Network
      • Contact: Emily Lozano; Phone Number: (786) 558-8892; Email: emily@globalliferesearch.com
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Lindus Health
      • Contact: Patient Recruitment Coordinator; Phone Number: 833-711-1429; Email: nightowl@lindushealth.com
      • Principal Investigator: Peter Polos, MD, PhD
  • New York
    • Garden City, New York, United States, 11530
      • Not yet recruiting
      • AccuMed
      • Contact: Leanne Cossu; Phone Number: 516-746-2190; Email: accumed@aol.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
2. Consistent schedule during daytime hours.
3. BMI 18.5 - 35 kg/m2 (inclusive).
4. Good physical and mental health as established by self-reported medical history.
5. Willingness to maintain and record their general habits, eating, and activity/exercise pattern for the study period.
6. Willingness to maintain and record the same time in bed they have during the workdays throughout the habitual workday sleep period.
7. Able to alter sleeping time during the study intervention period as instructed.
8. Willingness to maintain typical sleep hygiene patterns (e.g. sleep location, temperature, environment).
9. Willingness to maintain their current pattern of alcohol consumption for the duration of the study.
10. Willing and able to participate fully in all aspects of the study and complete all study procedures, including providing signed informed consent.
11. 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.
12. Has regular bowel habits with bowel movements on at least 5 days a week.
13. 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:

1. 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.
2. 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:

1. 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.
2. Average KSS Score of 1-5 on workdays during screening period. Note: Use standard rounding rules for averages with decimal places.

Exclusion:

1. 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.
2. 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.
3. 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.
4. Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
5. 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.
6. Neurodegenerative diseases (including multiple sclerosis, Parkinson's disease, Alzheimer's disease, dementia).
7. Recent history (current use or within the past 1 month) of smoking, vaping or other use of nicotine-containing products.
8. 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.
9. Drug abuse or dependence, including consistent recreational substance use such as marijuana.
10. 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.
11. Diagnosed neuropsychiatric disorders or symptoms possibly affecting sleep (generalized anxiety disorder (GAD), major depressive disorder (MDD), bipolar disorder, schizophrenia)
12. Any use of systemic antibiotics in the past 3 months. Topical or targeted antibiotic use (eye drop, ear drop) are allowed.
13. Any use of probiotic supplements in the past 2 weeks.
14. Any use of proton pump inhibitors (PPIs) in the past 2 weeks.
15. Pregnant or breastfeeding or planning to become pregnant.
16. 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.
17. Planned overnight or cross time zone travel during the study.
18. Females experiencing perimenopausal or menopausal symptoms, or those who have been diagnosed as perimenopausal or menopausal by a physician.
19. Any diagnosed condition or undiagnosed symptom which disrupts sleep, including, but not limited to, hyperthyroidism, night sweats, restless legs, or poorly controlled allergic rhinitis.
20. 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.
21. 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.
22. Varying work schedule and/or shift workers who work overnight shifts (e.g. 3rd shift, working late night to early morning hours)
23. Any other personal or medical condition that the investigator believes may bias or confound the results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cohort 1; 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.	Behavioral: Increase sleep by 90 minutes; For 14 days, participants will increase their nightly sleep by 90 minutes.
Active Comparator: Cohort 2; 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.	Behavioral: Decrease sleep by 90 minutes; For 14 days, participants will decrease their nightly sleep by 90 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Danisco

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IFF-NO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No