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 (9 - 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
Males and females 9 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,
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
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
Parallel
Magnesium Choline Citrate
Dietary supplementParticipants will be instructed to take two capsules twice per day with food starting on Day 1.
Placebo
Dietary supplementParticipants will be instructed to take two capsules twice per day with food starting on Day 1
PROMIS Cognitive Function- Short Form 8a (baseline 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
Pediatric Cognitive Function - Short Form 7a (baseline to day 84)
Change in cognitive function, as assessed by the Pediatric Cognitive Function - Short Form 7a (9-17 years old) from baseline to Day 84 between Magnesium Choline Citrate and placebo
PROMIS Cognitive Function- Short Form 8a (baseline 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
Pediatric Cognitive Function - Short Form 7a (baseline to day 42)
Change in cognitive function, as assessed by the Pediatric Cognitive Function - Short Form 7a (9-17 years old) from baseline to Day 42 between Magnesium Choline Citrate and placebo
PROMIS Emotional Distress - Anxiety - Short Form 8a (baseline 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
PROMIS Pediatric Anxiety - Short Form 8a (baseline to Days 42 and 84)
Change in feelings of anxiety, as assessed by the PROMIS Pediatric Anxiety - Short Form 8a (9-17 years old) from baseline to Days 42 and 84 between Magnesium Choline Citrate and placebo
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Click on the lead sponsor to view all of their trials.
Nutrisol, LLC
Lead sponsor
KGK Science Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
