Efforia - Decentralized United States Study
New York, 10003, United States
Location status: Recruiting
Location contact
Matthew Amsden
CONTACT
Matthew Amsden
PRINCIPAL_INVESTIGATOR
Viral Patel
SUB_INVESTIGATOR
NCT Number: NCT07717385
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10003, United States
Location status: Recruiting
Matthew Amsden
CONTACT
Matthew Amsden
PRINCIPAL_INVESTIGATOR
Viral Patel
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Bened Life Neuralli Mood
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Efforia, Inc
Industry
Effects of Neuralli Mood Probiotic Supplementation on Stress, Sleep Disturbance, Mood, and Burnout: A 90-Day Single-Arm Study
Acronym: NM90
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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