Sleep More, Stress Less: 90-Day Trial of Neuralli Mood

Официальное название

Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Neuralli Mood
  Two acid-resistant capsules taken once daily for 90 days. Each daily dose contains 30 billion CFU of L. plantarum PS128 and 20 billion heat-treated cells of L. paracasei PS23. Other ingredients include microcrystalline cellulose, hypromellose, pectin, glycerol, silica, and magnesium stearate.

Первичные конечные точки

• Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score [Срок оценки: Baseline before the first dose and end of the 90-day supplementation period]
• Change in PROMIS Sleep Disturbance Score [Срок оценки: Baseline before the first dose and end of the 90-day supplementation period]

Вторичные конечные точки (5)

• Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score [Срок оценки: Baseline before the first dose and end of the 90-day supplementation period]
• Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score [Срок оценки: Baseline before the first dose and end of the 90-day supplementation period]
• Change in Oxford Happiness Questionnaire Score [Срок оценки: Baseline before the first dose and end of the 90-day supplementation period]
• Change in Burnout Assessment Survey Score [Срок оценки: Baseline before the first dose and end of the 90-day supplementation period]
• Number of Participants With Treatment-Emergent Adverse Events [Срок оценки: From the first dose through completion of the 90-day supplementation period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Efforia - Decentralized United States Study — New York

Идентификаторы

NCT: NCT07717385 · EFF-NM-90D-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗