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NCT07685613
A Virtual Clinical Trial to Examine the Effect of Magnesium Choline Citrate on Cognitive Function and Anxiety in Healthy Adolescents and Adults
Conditions: Cognitive Function, Anxiety
Sex: All
Ages: 8 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 200
Sponsor: Nutrisol, LLC
Location: KGK Science Inc. London Ontario
Summary
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
Eligibility Criteria
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 \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
Source: ClinicalTrials.gov (NCT07685613). StuddyBuddy aggregates publicly available trial information.