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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 juni 2026 bijgewerkt door: 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

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Participants will be instructed to take two capsules twice per day with food starting on Day 1
Experimenteel: Magnesium Choline Citrate
Participants will be instructed to take two capsules twice per day with food starting on Day 1.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PROMIS Cognitive Function- Short Form 8a (baseline to day 84)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
PROMIS Cognitive Function- Short Form 8a (baseline to day 42)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of post-emergent adverse events (AE)
Tijdsspanne: Baseline (day 1) to day 84
Incidence of post-emergent adverse events (AE)
Baseline (day 1) to day 84

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medewerkers

Onderzoekers

  • Hoofdonderzoeker: David Crowley, KGK Science Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 april 2027

Studieregistratiedata

Eerst ingediend

29 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juni 2026

Eerst geplaatst (Werkelijk)

6 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 25NSRDM03

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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