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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 aktualisiert von: 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

Studienübersicht

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS Cognitive Function- Short Form 8a (baseline to day 84)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS Cognitive Function- Short Form 8a (baseline to day 42)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of post-emergent adverse events (AE)
Zeitfenster: Baseline (day 1) to day 84
Incidence of post-emergent adverse events (AE)
Baseline (day 1) to day 84

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Ermittler

  • Hauptermittler: David Crowley, KGK Science Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juni 2026

Zuerst gepostet (Tatsächlich)

6. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25NSRDM03

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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