Anxiety Symptoms, Depressive Symptoms, Occupational Burnout, Psychological Stress, Sleep Disturbance
Conditions
Keywords
Neuralli Mood, Probiotic, Postbiotic, Psychobiotic, Gut-brain axis, Lactiplantibacillus plantarum PS128, Lacticaseibacillus paracasei PS23, Stress, Sleep, Burnout, Citizen science
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTNeuralli 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.
Sponsors
Efforia, Inc
Bened Life
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Participants and investigators know that Neuralli Mood is being administered. No placebo or blinded comparator is used.
Intervention model description
All participants complete baseline assessments, take two capsules of Neuralli Mood daily for 90 days, complete scheduled adherence and safety check-ins, and repeat the outcome assessments at the end of the supplementation period. Each participant serves as his or her own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | Baseline before the first dose and end of the 90-day supplementation period | 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 | Baseline before the first dose and end of the 90-day supplementation period | 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 | Baseline before the first dose and end of the 90-day supplementation period | 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) |
| Number of Participants With Treatment-Emergent Adverse Events | From the first dose through completion of the 90-day supplementation period | Number and proportion of participants reporting adverse events during supplementation, including gastrointestinal symptoms, allergic reactions, mood changes, sleep-related symptoms, discontinuations, and events requiring medical attention. |
Countries
United States
Contacts
CONTACTMatthew Amsden
PRINCIPAL_INVESTIGATORMatthew Amsden
Efforia, Inc
Outcome results
None listed