NCT07717385

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Sep 2027

Study Start

First participant enrolled

June 30, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 13, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Neuralli MoodProbioticPostbioticPsychobioticGut-brain axisLactiplantibacillus plantarum PS128Lacticaseibacillus paracasei PS23StressSleepBurnoutCitizen science

Outcome Measures

Primary Outcomes (2)

  • 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).

    Baseline before the first dose and end of the 90-day supplementation period

  • 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.

    Baseline before the first dose and end of the 90-day supplementation period

Secondary Outcomes (5)

  • 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 in Depression Anxiety and Stress Scales-21 Depression Subscale Score

    Baseline before the first dose and end of the 90-day supplementation period

  • Change in Oxford Happiness Questionnaire Score

    Baseline before the first dose and end of the 90-day supplementation period

  • Change in Burnout Assessment Survey Score

    Baseline before the first dose and end of the 90-day supplementation period

  • Number of Participants With Treatment-Emergent Adverse Events

    From the first dose through completion of the 90-day supplementation period

Study Arms (1)

Neuralli Mood Supplementation

EXPERIMENTAL

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

Interventions

Neuralli MoodDIETARY_SUPPLEMENT

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.

Also known as: Bened Life Neuralli Mood
Neuralli Mood Supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Efforia - Decentralized United States Study

New York, New York, 10003, United States

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalParasomniasAnxiety DisordersDepressionBurnout, ProfessionalBurnout, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Wake DisordersNervous System DiseasesMental DisordersOccupational StressOccupational Diseases

Study Officials

  • Matthew Amsden

    Efforia, Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Amsden

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants and investigators know that Neuralli Mood is being administered. No placebo or blinded comparator is used.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 21, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

September 28, 2027

Study Completion (Estimated)

September 28, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Locations