The Microbiome and Resilience to Sleep and Circadian Disruption

NCT03747367 | Completed

• 1 other identifier: 15-0282
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Sleep Deprivation; Circadian Dysregulation; Stress

Keywords

Microbiome; Stress; Sleep; Circadian

Outcome Measures

Primary Outcomes (2)

• Change in fecal microbiome

  Fecal "beta diversity" (unit=weighted UniFrac)

  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)

  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

  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

  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

  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

  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)

Study Arms (4)

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.

Behavioral: Insufficient Sleep

Experiment 3 and 4 Placebo

PLACEBO COMPARATOR

14 days of placebo (Maltodextrin). 15g/day

Dietary Supplement: Placebo

Experiment 3 and 4 Prebiotic

ACTIVE COMPARATOR

14 days of Polydextrose and Galacto-oligosaccharides, 7.5g each/day

Dietary Supplement: Prebiotic

Interventions

Insufficient Sleep BEHAVIORAL

Experiment 1 and 2 Insufficient Sleep

Prebiotic DIETARY_SUPPLEMENT

Polydextrose and Galacto-oligosaccharide prebiotic supplement

Experiment 3 and 4 Prebiotic

Placebo DIETARY_SUPPLEMENT

Maltodextrin (placebo) supplement

Experiment 3 and 4 Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Currently residing at Denver altitude or higher

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• University of California, San Diego: collaborator
• Office of Naval Research (ONR): collaborator

Study Sites (1)

Sleep and Chronobiology Laboratory

Boulder, Colorado, 80309-0554, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Chronobiology Disorders

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Kenneth Wright, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Experiment 1 - none Experiment 2 - double-blind Experiment 3 - double-blind Experiment 4 - double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 20, 2018
• Study Start: October 21, 2015
• Primary Completion: March 12, 2020
• Study Completion: March 16, 2020
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon publication, microbiome data to be deposited permanently in International Nucleotide Sequence Database Collaboration www.insdc.org/ Data already deposited in Qiita http://qiita.microbio.me Upon publication, metabolomics data to be deposited permanently in Global Natural Products Social (GNPS) molecular networking http://gnps.ucsd.edu
• Access Criteria: data will be freely available at www.insdc.org/ and http://gnps.ucsd.edu

Locations

US (1)