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

16. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10003
        • Rekruttering
        • Efforia - Decentralized United States Study
        • Kontakt:
        • Ledende efterforsker:
          • Matthew Amsden
        • Underforsker:
          • Viral Patel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: 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.
Andre navne:
  • Bened Life Neuralli Mood

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Depression Anxiety and Stress Scales-21 Stress Subscale Score
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Depression Anxiety and Stress Scales-21 Anxiety Subscale Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efforia, Inc

Samarbejdspartnere

Bened Life

Efterforskere

  • Ledende efterforsker: Matthew Amsden, Efforia, Inc

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juni 2026

Primær færdiggørelse (Anslået)

28. september 2027

Studieafslutning (Anslået)

28. september 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EFF-NM-90D-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

No individual participant data sharing plan has been finalized.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Søvnforstyrrelser

Kliniske forsøg med Neuralli Mood

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