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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score — 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 — 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.

Trial sites (1)

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