- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07685613
A Virtual Clinical Trial to Examine the Effect of Magnesium Choline Citrate on Cognitive Function and Anxiety in Healthy Adolescents and Adults
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
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Erin Lewis, PhD
- Número de teléfono: 248 1-226-242-4551
- Correo electrónico: elewis@kgkscience.com
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá, N5Y 5V6
- KGK Science Inc.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Males and females 8 years and older
- 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:
- Memory
- Focus
- 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:
- Individuals who self-report as pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
- Self-reported ongoing diagnosis of a neuropsychiatric condition and/or cognitive impairment
- Self-reported ongoing diagnosis with a stress or anxiety disorder
Self-reported ongoing and unstable diseases/conditions in the past six months, including:
- Gastrointestinal diseases
- Hypertension
- Type I or type II diabetes
- Cardiovascular disease
- Kidney and/or liver diseases
- Thyroid condition
- Self-reported major surgery in the past 3 months or individuals who have planned surgery during the course of the study.
- 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
- Individuals with self-reported autoimmune disease or are immune compromised
- Alcohol intake average of >2 standard drinks per day
- Alcohol or drug abuse within the last 12 months that has required treatment
- 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)
- Participation in other clinical research studies 30 days prior to baseline
- Individuals who are unable to give informed consent
- 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
¿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
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Experimental: Magnesium Choline Citrate
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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
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Crowley, KGK Science Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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