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

Official title

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

Overview

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

Interventions

• Dietary supplement Magnesium Choline Citrate
  Participants will be instructed to take two capsules twice per day with food starting on Day 1.
• Dietary supplement Placebo
  Participants will be instructed to take two capsules twice per day with food starting on Day 1

Primary outcome measures

• PROMIS Cognitive Function- Short Form 8a (baseline to day 84) [Time frame: Baseline (day 1) to day 84]
• Pediatric Cognitive Function - Short Form 7a (baseline to day 84) [Time frame: Baseline (day 1) to day 84]

Secondary outcome measures (4)

• PROMIS Cognitive Function- Short Form 8a (baseline to day 42) [Time frame: Baseline (day 1) to day 42]
• Pediatric Cognitive Function - Short Form 7a (baseline to day 42) [Time frame: Baseline (day 1) to day 42]
• PROMIS Emotional Distress - Anxiety - Short Form 8a (baseline to Days 42 and 84) [Time frame: Baseline (day 1) to days 42 and 84]
• PROMIS Pediatric Anxiety - Short Form 8a (baseline to Days 42 and 84) [Time frame: Baseline (day 1) to days 42 and 84]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• KGK Science Inc. — London

Identifiers

NCT: NCT07685613 · 25NSRDM03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗