Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score
研究概览
简要总结
This decentralized, single-arm study evaluates the effects of 90 days of daily Neuralli Mood supplementation on perceived stress, sleep disturbance, mood, anxiety, depressive symptoms, happiness, and occupational burnout in adults experiencing stress or occasional sleep disruption. Participants serve as their own controls, completing validated self-report measures before beginning supplementation and again after the 90-day intervention, with safety and adherence check-ins during the study.
详细描述
Neuralli Mood is a probiotic and postbiotic dietary supplement containing the proprietary gut-brain strains L. plantarum PS128 and heat-treated L. paracasei PS23. Participants take two capsules once daily, with or without food, at a consistent time for 90 days. Each two-capsule daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23.
The study uses a prospective, open-label, single-group, within-participant design. Participants complete baseline assessments before the first dose and repeat the primary and secondary outcome assessments at the end of the 90-day supplementation period. Scheduled check-ins are used to assess adherence, tolerability, and adverse events.
The study is exploratory and is intended to generate preliminary evidence and individualized before-and-after information. Results will be interpreted in light of the absence of a concurrent control group, participant self-selection, expectation effects, and reliance on self-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants and investigators know that Neuralli Mood is being administered. No placebo or blinded comparator is used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older and able to provide informed consent.
- •Generally healthy adult experiencing stress, occasional sleep disruption, low mood, anxiety symptoms, or work-related burnout.
- •Willing and able to take two capsules of Neuralli Mood daily for 90 days.
- •Willing and able to complete electronic baseline, follow-up, adherence, and safety assessments.
- •Has reliable access to the internet and an email-enabled device.
排除标准
- •Pregnant or nursing.
- •Known allergy or hypersensitivity to Neuralli Mood, probiotics, or any product ingredient.
- •Severe or unstable gastrointestinal disease, including a condition for which probiotic use may be inappropriate.
- •Immunocompromised status or current immunosuppressive therapy.
- •Severe or unstable mood disorder, acute psychiatric symptoms, or a current risk of harm to self or others.
- •A clinically significant sleep disorder for which participation or changes in symptoms should be managed by a healthcare professional.
- •Cognitive impairment or another condition that prevents informed consent or reliable completion of study procedures.
- •History of a severe allergic reaction when the investigator determines probiotic use may present an unacceptable risk.
- •Use of a medication or presence of a medical condition for which a healthcare professional advises against probiotic supplementation.
- •Any other circumstance that, in the investigator's judgment, makes participation inappropriate or unsafe.
结局指标
主要结局
Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score
时间窗: Baseline before the first dose and end of the 90-day supplementation period
Change from baseline in the Stress subscale score of the Depression Anxiety and Stress Scales-21. Higher scores (maximum score of 42) represent greater severity of stress symptoms. (Minimum score of 0).
Change in PROMIS Sleep Disturbance Score
时间窗: Baseline before the first dose and end of the 90-day supplementation period
Change from baseline in the PROMIS Sleep Disturbance score. Higher scores (Maximum 40) represent greater sleep disturbance. Lower (Minimum 8) represent lower sleep disturbance.
次要结局
- Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score(Baseline before the first dose and end of the 90-day supplementation period)
- Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score(Baseline before the first dose and end of the 90-day supplementation period)
- Change in Oxford Happiness Questionnaire Score(Baseline before the first dose and end of the 90-day supplementation period)
- Change in Burnout Assessment Survey Score(Baseline before the first dose and end of the 90-day supplementation period)
- Number of Participants With Treatment-Emergent Adverse Events(From the first dose through completion of the 90-day supplementation period)