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.
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.
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.
Single group
Neuralli Mood
Dietary supplementTwo 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.
Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score
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
Change from baseline in the PROMIS Sleep Disturbance score. Higher scores (Maximum 40) represent greater sleep disturbance. Lower (Minimum 8) represent lower sleep disturbance.
Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score
Change from baseline in the Anxiety subscale score of the Depression Anxiety and Stress Scales-21. Higher scores represent greater severity of anxiety symptoms. (minimum 0 to maximum 21)
Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score
Change from baseline in the Depression subscale score of the Depression Anxiety and Stress Scales-21. Higher scores represent greater severity of depressive symptoms. (Minumum 0, maximum 21)
Change in Oxford Happiness Questionnaire Score
Change from baseline in the Oxford Happiness Questionnaire total score. Higher raw scores (max 174) represent greater self-reported happiness versus low scores (min 29).
Change in Burnout Assessment Survey Score
Change from baseline in the total score from the study's Burnout Assessment Survey, interpreted according to the instrument's scoring procedures. Raw Sum Minimum Score: 23 (Patient responds "Never" to every single item)Raw Sum Maximum Score: 115 (Patient responds "Always" to every single item)
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Efforia, Inc
Lead sponsor
Bened Life
Collaborator
