Effect of L. Reuteri LM1063 on Sleep Health Improvement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorLactomason Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Limosilactobacillus reuteri LM1063
Dietary supplementA 500 mg capsule containing Limosilactobacillus reuteri LM1063 (1.0 x 10\^10 CFU/day).
Placebo
Dietary supplementAn identical-looking 500 mg capsule containing inactive ingredients such as processed starch, maltodextrin, and magnesium stearate..
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: L. reuteri LM1063Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Sleep Efficiency (SE)
Measured as (Total Sleep Time / Time in Bed) x 100.
Time frame
Baseline (Day 0) and Week 8 (Day 56)2
Change from Baseline in Sleep Latency (SL)
Time taken to fall asleep from lights out.
Time frame
Baseline (Day 0) and Week 8 (Day 56)3
Change from Baseline in Total Sleep Time (TST)
Total minutes spent in sleep during the study period.
Time frame
Baseline (Day 0) and Week 8 (Day 56)4
Change from Baseline in Wake After Sleep Onset (WASO)
Total minutes awake after sleep onset until final awakening.
Time frame
Baseline (Day 0) and Week 8 (Day 56)Secondary outcomes
1
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).
Time frame
Baseline (Day 0) and Week 8 (Day 56)2
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).
Time frame
Baseline (Day 0) and Week 8 (Day 56)3
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).
Time frame
Baseline (Day 0) and Week 8 (Day 56)4
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).
Time frame
Baseline (Day 0) and Week 8 (Day 56)Sponsors and contacts
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Source ClinicalTrials.gov