- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07766642
A Clinical Trial to Evaluate the Effects of a Supplement on Children's Focus and Energy
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89101
- Citruslabs
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Focus
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Parent-Reported Focus
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20827
- legacy-20827
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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