Sleep More, Stress Less: 90-Day Trial of Neuralli Mood (NM90)

July 16, 2026 updated by: Efforia, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • Recruiting
        • Efforia - Decentralized United States Study
        • Contact:
        • Principal Investigator:
          • Matthew Amsden
        • Sub-Investigator:
          • Viral Patel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuralli Mood Supplementation
Participants take two capsules of Neuralli Mood once daily, with or without food, at a consistent time for 90 days and complete scheduled study assessments and safety check-ins.
Dietary supplement: 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.
Other Names:
  • Bened Life Neuralli Mood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score
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).
Baseline before the first dose and end of the 90-day supplementation period
Change in PROMIS Sleep Disturbance Score
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.
Baseline before the first dose and end of the 90-day supplementation period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score
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)
Baseline before the first dose and end of the 90-day supplementation period
Change in Depression Anxiety and Stress Scales-21 Depression Subscale Score
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)
Baseline before the first dose and end of the 90-day supplementation period
Change in Oxford Happiness Questionnaire Score
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).
Baseline before the first dose and end of the 90-day supplementation period
Change in Burnout Assessment Survey Score
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)
Baseline before the first dose and end of the 90-day supplementation period
Number of Participants With Treatment-Emergent Adverse Events
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.
From the first dose through completion of the 90-day supplementation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Efforia, Inc

Collaborators

Bened Life

Investigators

  • Principal Investigator: Matthew Amsden, Efforia, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2026

Primary Completion (Estimated)

September 28, 2027

Study Completion (Estimated)

September 28, 2027

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFF-NM-90D-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No individual participant data sharing plan has been finalized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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