Sleep Quality, Sleep Wake Disorders
Conditions
Keywords
probiotics, Limosilactobacillus reuteri, sleep health, L. reuteri LM1063, gut-brain axis
Brief summary
Purpose: The purpose of this clinical trial is to evaluate the efficacy and safety of Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults. Based on the microbiota-gut-brain axis, this study aims to scientifically analyze whether the supplementation of this specific probiotic strain can enhance sleep quality. Methodology: This is a randomized, double-blind, placebo-controlled, single-center clinical trial. A total of 80 participants (40 in the test group and 40 in the control group) will be enrolled. Participants in the test group will consume 500 mg of L. reuteri LM1063 (1.0 x 10\^10 CFU/day) once daily for 8 weeks, while the control group will receive a placebo. Key Evaluations: To assess sleep improvement, various parameters will be measured before and after the 8-week intake period: * Primary Outcomes: Polysomnography (PSG) measures including sleep efficiency (SE), sleep latency (SL), total sleep time (TST), wake after sleep onset (WASO), and delta power; and the Pittsburgh Sleep Quality Index (PSQI). * Secondary Outcomes: Various sleep and stress-related scales (SSS, ESS, PSS, RSQ-W, FSS) and blood biomarkers such as melatonin, GABA, and serotonin levels. * Safety: Monitored through adverse events, vital signs, and clinical laboratory tests.
Interventions
DIETARY_SUPPLEMENTLimosilactobacillus reuteri LM1063
A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10\^10 CFU/day).
DIETARY_SUPPLEMENTPlacebo
An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate..
Sponsors
Lactomason Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female adults aged 19 to 65. * Pittsburgh Sleep Quality Index (PSQI) score of 5 or higher. * Voluntarily agreed to participate and signed the informed consent form.
Exclusion criteria
* Severe sleep disorders (Insomnia Severity Index ≥ 22 or ≤ 7). * Medical conditions causing sleep disorders (Sleep apnea, Restless legs syndrome, Depression, Narcolepsy, etc.). * Intake of medications affecting sleep within 1 month before the first visit. * Intake of probiotics or fermented milk products within 1 month before the first visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Sleep Efficiency (SE) | Baseline (Day 0) and Week 8 (Day 56) | Measured as (Total Sleep Time / Time in Bed) x 100. |
| Change from Baseline in Sleep Latency (SL) | Baseline (Day 0) and Week 8 (Day 56) | Time taken to fall asleep from lights out. |
| Change from Baseline in Total Sleep Time (TST) | Baseline (Day 0) and Week 8 (Day 56) | Total minutes spent in sleep during the study period. |
| Change from Baseline in Wake After Sleep Onset (WASO) | Baseline (Day 0) and Week 8 (Day 56) | Total minutes awake after sleep onset until final awakening. |
| Change from Baseline in Delta Power | Baseline (Day 0) and Week 8 (Day 56) | EEG power density in the delta frequency band (2-4Hz) during sleep. |
| Change in Pittsburgh Sleep Quality Index (PSQI) Total Score | Baseline (Day 0) and Week 8 (Day 56) | The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Stanford Sleepiness Scale (SSS) | Baseline (Day 0) and Week 8 (Day 56) | The SSS is a 7-point scale used to assess acute sleepiness. It consists of 7 descriptive statements ranging from 1 to 7. Scores range from 1 to 7, where a higher score indicates a greater degree of sleepiness (worse outcome). |
| Change from Baseline in Epworth Sleepiness Scale (ESS) | Baseline (Day 0) and Week 8 (Day 56) | The ESS is used to assess general daytime sleepiness by evaluating the likelihood of dozing off in 8 different situations. Each situation is rated on a 4-point scale (0-3). Total scores range from 0 to 24, where a score of 11 or higher indicates abnormal excessive daytime sleepiness. Higher scores indicate greater daytime sleepiness (worse outcome). |
| Change from Baseline in Perceived Stress Scale (PSS) | Baseline (Day 0) and Week 8 (Day 56) | The PSS-10 consists of 10 items assessing the degree to which situations in life are appraised as stressful over the past month. Each item is rated on a 5-point Likert scale (0-4). Total scores range from 0 to 40, with higher scores indicating a higher level of perceived stress (worse outcome). |
| Change from Baseline in Recovery after Sleep Questionnaire-Weekly (RSQ-W) | Baseline (Day 0) and Week 8 (Day 56) | The RSQ-W evaluates the feeling of recovery and mood upon waking up and starting the day over the past 7 days. Participants self-rate each item on a scale of 1 to 5. Higher total or average scores indicate a better quality of restorative sleep (better outcome). |
| Change from Baseline in Fatigue Severity Scale (FSS) | Baseline (Day 0) and Week 8 (Day 56) | The FSS measures the severity of fatigue and its impact on daily activities over the past 2 weeks. It consists of 9 items, each rated on a 7-point scale (1-7). The fatigue score is the average of the 9 items (range 1-7), where a score of 4 or higher indicates severe fatigue. Higher scores indicate greater fatigue severity (worse outcome). |
| Change from Baseline in Blood Melatonin Levels | Baseline (Day 0) and Week 8 (Day 56) | Blood melatonin levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063. |
| Change from Baseline in Blood Gamma-Aminobutyric Acid (GABA) Levels | Baseline (Day 0) and Week 8 (Day 56) | Blood GABA levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063. |
| Change from Baseline in Blood Serotonin Levels | Baseline (Day 0) and Week 8 (Day 56) | Blood serotonin levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063. |
| Incidence of Adverse Events and Safety Assessment | Throughout the study period (Up to 8 weeks) | Evaluation of safety through the monitoring of Adverse Events (AEs), changes in vital signs, and clinical laboratory test results (hematology and blood chemistry). |
Countries
South Korea
Contacts
CONTACTYu-Na Jung
Outcome results
None listed