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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. reuteri LM1063 | Experimental | Participants in this arm will receive one capsule containing 500 mg of Limosilactobacillus reuteri LM1063 (1.0 x 10^10 CFU/day) once daily, one hour before bedtime for 8 weeks. |
|
| Placebo | Placebo Comparator | Participants in this arm will receive one placebo capsule (containing processed starch, etc.) identical in appearance to the test product, once daily, one hour before bedtime for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limosilactobacillus reuteri LM1063 | Dietary Supplement | A 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10^10 CFU/day). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Sleep Efficiency (SE) | Measured as (Total Sleep Time / Time in Bed) x 100. | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Sleep Latency (SL) | Time taken to fall asleep from lights out. | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Total Sleep Time (TST) | Total minutes spent in sleep during the study period. | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Wake After Sleep Onset (WASO) | Total minutes awake after sleep onset until final awakening. | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Delta Power | EEG power density in the delta frequency band (2-4Hz) during sleep. | Baseline (Day 0) and Week 8 (Day 56) |
| Change in Pittsburgh Sleep Quality Index (PSQI) Total Score | 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. | Baseline (Day 0) and Week 8 (Day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Stanford Sleepiness Scale (SSS) | 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). | Baseline (Day 0) and Week 8 (Day 56) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Na Jung | Contact | 82-55-360-5988 | ynltm0401@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P&K Skin Research Center | Recruiting | Seoul | Yeongdeungpo | 07236 | South Korea |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Placebo | Dietary Supplement | An identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate.. |
|
| Change from Baseline in Epworth Sleepiness Scale (ESS) |
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). |
| Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Perceived Stress Scale (PSS) | 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). | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Recovery after Sleep Questionnaire-Weekly (RSQ-W) | 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). | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Fatigue Severity Scale (FSS) | 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). | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Blood Melatonin Levels | Blood melatonin levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063. | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Blood Gamma-Aminobutyric Acid (GABA) Levels | Blood GABA levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063. | Baseline (Day 0) and Week 8 (Day 56) |
| Change from Baseline in Blood Serotonin Levels | Blood serotonin levels will be analyzed to evaluate the sleep-improving effect of L. reuteri LM1063. | Baseline (Day 0) and Week 8 (Day 56) |
| Incidence of Adverse Events and Safety Assessment | Evaluation of safety through the monitoring of Adverse Events (AEs), changes in vital signs, and clinical laboratory test results (hematology and blood chemistry). | Throughout the study period (Up to 8 weeks) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |