Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07717385

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Efforia - Decentralized United States Study

New York, 10003, United States

Location status: Recruiting

Location contact

Matthew Amsden

CONTACT

[email protected]

Matthew Amsden

PRINCIPAL_INVESTIGATOR

Viral Patel

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuralli Mood

Dietary 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.

Other names: Bened Life Neuralli Mood

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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).

  4. 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)

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Amsden

CONTACT

[email protected]

+13232844626

Sponsors and collaborators

Lead sponsor

Efforia, Inc

Industry

Collaborators

  • Bened Life

Registry information

Official study title

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

Acronym: NM90

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

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.

Published trials that share one or more normalized conditions with this study.