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A Clinical Trial to Evaluate the Effects of a Supplement on Children's Focus and Energy

11. august 2026 oppdatert av: Auri Nutrition

This study will evaluate the effects of the Auri Super Mushroom Daily Gummies For Kids on focus and energy in children aged 4-12. The study is a single-arm, unblinded, virtual trial conducted over 8 weeks, in which all 35 enrolled participants will use the test product daily.

Parents of the participants will complete questionnaires at Baseline, Week 2, Week 4, Week 6, and Week 8 to assess perceived changes in their child's focus, attention, sleep quality, gut health, natural energy, and overall well-being. Participants will also undergo cognitive battery testing at Baseline, Week 4, and Week 8 to provide objective measurements of focus and cognitive performance.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

35

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89101
        • Citruslabs

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Be male or female.
  • Be aged 4-12.
  • Parent(s) reporting that their child has been experiencing issues regarding any of the following for the past four weeks: Difficulty focusing, Poor concentration, or Poor memory.
  • Parent(s) who report that their child will be willing to complete cognitive assessments at regular intervals during the study.
  • Any child who is generally healthy - does not live with any uncontrolled chronic disease.
  • Parent(s) who are willing to follow the study protocol and support their child to complete all study actions.
  • Any child who has no planned changes to school schedule, sleep routines, or behavioral therapies during the study duration.
  • Anyone willing to refrain from introducing any new prescription medications, wellness products, supplements, or herbal remedies into their child's routine during the test period.
  • If the child has been taking any other products, supplements, or herbal remedies, they have been taking these consistently for at least three months.
  • Has had a stable diet and sleep schedule for at least four weeks prior to the study.
  • Enrolled in and currently attending school at baseline and for the duration of the study period.
  • Resides in the United States.

Exclusion Criteria:

  • Any child with a neurodevelopmental condition or developmental delay, including autism spectrum disorder, intellectual disability, language disorder, uncontrolled anxiety or mood disorder, or dyslexia.
  • Previous diagnosis of Attention-deficit hyperactivity disorder (ADHD).
  • Any child currently undergoing any assessments for suspected neurodevelopmental conditions or developmental delay.
  • Any child diagnosed with epilepsy or a seizure disorder.
  • Any child diagnosed with a bleeding disorder.
  • Any child with any known allergies or hypersensitivities to any supplement product ingredients.
  • Any child with any chronic health conditions that could impact their participation in this study, such as cancer, mental health disorders, a history of serious illness in the last three months, or planned surgery during the study period.
  • Any parent or child currently testing, or planning on starting in the next eight weeks, a product for another research study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Auri Super Mushroom Daily Gummies For Kids
Kosttilskudd: Auri Super Mushroom Daily Gummies For Kids
All participants receive two Auri Super Mushroom Daily Gummies once daily in the morning with their first meal of the day for 8 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Focus
Tidsramme: Baseline, Week 4, and Week 8
Assessed via cognitive battery testing (Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, Spatial Planning) and self-reported questionnaire
Baseline, Week 4, and Week 8
Change in Cognitive Performance
Tidsramme: Baseline, Week 4, and Week 8
Assessed via cognitive battery testing (Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, Spatial Planning) and self-reported questionnaire
Baseline, Week 4, and Week 8

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Parent-Reported Focus
Tidsramme: Baseline, Week 2, Week 4, Week 6, and Week 8
Assessed via parent-completed self-reported questionnaire
Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Parent-Reported Attention
Tidsramme: Baseline, Week 2, Week 4, Week 6, and Week 8
Assessed via parent-completed self-reported questionnaire
Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Parent-Reported Sleep Quality
Tidsramme: Baseline, Week 2, Week 4, Week 6, and Week 8
Assessed via parent-completed self-reported questionnaire
Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Parent-Reported Gut Health
Tidsramme: Baseline, Week 2, Week 4, Week 6, and Week 8
Assessed via parent-completed self-reported questionnaire
Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Parent-Reported Natural Energy
Tidsramme: Baseline, Week 2, Week 4, Week 6, and Week 8
Assessed via parent-completed self-reported questionnaire
Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Parent-Reported Overall Well-Being
Tidsramme: Baseline, Week 2, Week 4, Week 6, and Week 8
Assessed via parent-completed self-reported questionnaire
Baseline, Week 2, Week 4, Week 6, and Week 8

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Auri Nutrition

Samarbeidspartnere

Citruslabs

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. mars 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

11. august 2026

Først innsendt som oppfylte QC-kriteriene

11. august 2026

Først lagt ut (Faktiske)

14. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20827
  • legacy-20827

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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