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

11 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

35

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89101
        • Citruslabs

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Focus
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Parent-Reported Focus
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de marzo de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

1 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de agosto de 2026

Publicado por primera vez (Actual)

14 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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