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A Virtual Clinical Trial to Examine the Effect of Magnesium Choline Citrate on Cognitive Function and Anxiety in Healthy Adolescents and Adults

29 de junio de 2026 actualizado por: Nutrisol, LLC

A Randomized, Triple-blind, Placebo Controlled, Parallel Virtual Clinical Trial to Examine the Effect of Magnesium Choline Citrate on Cognitive Function and Anxiety in Healthy Adolescents and Adults

The goal of this clinical trial is to examine the effect of Magnesium Choline Citrate on cognitive function and anxiety in healthy adolescents and adults. The main questions it aims to answer are:

  • What is the change in cognitive function, as assessed by the PROMIS Cognitive Function- Short Form 8a (≥18 years old) from baseline to Day 84 between Magnesium Choline Citrate and placebo?
  • What is the change in cognitive function, as assessed by the Pediatric Cognitive Function - Short Form 7a (8 - 17 years old) from baseline to Day 84 between Magnesium Choline Citrate and placebo?

Researchers will compare Magnesium Choline Citrate with placebo to evaluate its effects on cognitive function and anxiety symptoms. Participants will be asked to:

  • Consume either Magnesium Choline Citrate or placebo for 84 days
  • Complete questionnaires (PROMIS Cognitive Function- Short Form 8a/Pediatric Cognitive Function - Short Form 7a, and PROMIS Emotional Distress - Anxiety - Short Form 8a/Pediatric Anxiety - Short Form 8a)
  • Complete a study diary weekly

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

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.

Estudio Contacto

  • Nombre: Erin Lewis, PhD
  • Número de teléfono: 248 1-226-242-4551
  • Correo electrónico: elewis@kgkscience.com

Ubicaciones de estudio

    • Ontario
      • London, Ontario, Canadá, N5Y 5V6
        • KGK Science Inc.

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
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  1. Males and females 8 years and older
  2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,

Individuals of child-bearing potential must confirm negative baseline pregnancy status and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
  • Intrauterine devices
  • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
  • Vasectomy of partner at least 6 months prior to screening
  • Abstinence and agrees to use contraception if planning on becoming sexually active during the study 3. Has recently noticed a worsening in or wishes to improve one or all of the following:

    1. Memory
    2. Focus
    3. Attention *Participants <18 years of age will require parent/guardian confirmation of self-perceived worsening in or wishes to improve memory, focus or attention 4. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study 5. Agrees to and self-reports ability to consume study product, and complete all questionnaires, diaries, and assessments required for participation 6. Provided voluntary, written, informed consent to participate in the study 7. Generally healthy as determined by medical history with no unstable diagnosed medical conditions

Exclusion Criteria:

  1. Individuals who self-report as pregnant, breast feeding, or planning to become pregnant during the study
  2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
  3. Self-reported ongoing diagnosis of a neuropsychiatric condition and/or cognitive impairment
  4. Self-reported ongoing diagnosis with a stress or anxiety disorder
  5. Self-reported ongoing and unstable diseases/conditions in the past six months, including:

    1. Gastrointestinal diseases
    2. Hypertension
    3. Type I or type II diabetes
    4. Cardiovascular disease
    5. Kidney and/or liver diseases
    6. Thyroid condition
  6. Self-reported major surgery in the past 3 months or individuals who have planned surgery during the course of the study.
  7. Self-reported cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  8. Individuals with self-reported autoimmune disease or are immune compromised
  9. Alcohol intake average of >2 standard drinks per day
  10. Alcohol or drug abuse within the last 12 months that has required treatment
  11. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
  12. Participation in other clinical research studies 30 days prior to baseline
  13. Individuals who are unable to give informed consent
  14. Any other condition or lifestyle factor that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Participants will be instructed to take two capsules twice per day with food starting on Day 1
Experimental: Magnesium Choline Citrate
Participants will be instructed to take two capsules twice per day with food starting on Day 1.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PROMIS Cognitive Function- Short Form 8a (baseline to day 84)
Periodo de tiempo: Baseline (day 1) to day 84
Change in cognitive function, as assessed by the PROMIS Cognitive Function- Short Form 8a (≥18 years old) from baseline to Day 84 between Magnesium Choline Citrate and placebo
Baseline (day 1) to day 84
Pediatric Cognitive Function - Short Form 7a (baseline to day 84)
Periodo de tiempo: Baseline (day 1) to day 84
Change in cognitive function, as assessed by the Pediatric Cognitive Function - Short Form 7a (8-17 years old) from baseline to Day 84 between Magnesium Choline Citrate and placebo
Baseline (day 1) to day 84

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PROMIS Cognitive Function- Short Form 8a (baseline to day 42)
Periodo de tiempo: Baseline (day 1) to day 42
Change in cognitive function, as assessed by the PROMIS Cognitive Function- Short Form 8a (≥18 years old) from baseline to Day 42 between Magnesium Choline Citrate and placebo
Baseline (day 1) to day 42
Pediatric Cognitive Function - Short Form 7a (baseline to day 42)
Periodo de tiempo: Baseline (day 1) to day 42
Change in cognitive function, as assessed by the Pediatric Cognitive Function - Short Form 7a (8-17 years old) from baseline to Day 42 between Magnesium Choline Citrate and placebo
Baseline (day 1) to day 42
PROMIS Emotional Distress - Anxiety - Short Form 8a (baseline to Days 42 and 84)
Periodo de tiempo: Baseline (day 1) to days 42 and 84
Change in feelings of anxiety, as assessed by the PROMIS Emotional Distress - Anxiety - Short Form 8a (≥18 years old) from baseline to Days 42 and 84 between Magnesium Choline Citrate and placebo
Baseline (day 1) to days 42 and 84
PROMIS Pediatric Anxiety - Short Form 8a (baseline to Days 42 and 84)
Periodo de tiempo: Baseline (day 1) to days 42 and 84
Change in feelings of anxiety, as assessed by the PROMIS Pediatric Anxiety - Short Form 8a (8-17 years old) from baseline to Days 42 and 84 between Magnesium Choline Citrate and placebo
Baseline (day 1) to days 42 and 84

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of post-emergent adverse events (AE)
Periodo de tiempo: Baseline (day 1) to day 84
Incidence of post-emergent adverse events (AE)
Baseline (day 1) to day 84

Colaboradores e Investigadores

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

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: David Crowley, KGK Science Inc.

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 (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de junio de 2026

Publicado por primera vez (Actual)

6 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

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

29 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 25NSRDM03

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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