A Clinical Trial to Evaluate the Effects of a Supplement on Children's Focus and Energy
11. august 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
35
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89101
- Citruslabs
-
-
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
- Barn
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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)
13. marts 2026
Primær færdiggørelse (Anslået)
1. september 2026
Studieafslutning (Anslået)
1. september 2026
Datoer for studieregistrering
Først indsendt
11. august 2026
Først indsendt, der opfyldte QC-kriterier
11. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20827
- legacy-20827
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