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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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:
Researchers will compare Magnesium Choline Citrate with placebo to evaluate its effects on cognitive function and anxiety symptoms. Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium Choline Citrate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Choline Citrate | Dietary Supplement | Participants will be instructed to take two capsules twice per day with food starting on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (day 1) to day 84 |
| Pediatric Cognitive Function - Short Form 7a (baseline 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (day 1) to day 42 |
| Pediatric Cognitive Function - Short Form 7a (baseline to day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | Baseline (day 1) to day 84 |
Inclusion Criteria:
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:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Lewis, PhD | Contact | 1-226-242-4551 | 248 | elewis@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N5Y 5V6 | Canada |
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| Placebo | Dietary Supplement | Participants will be instructed to take two capsules twice per day with food starting on Day 1 |
|
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) | 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) | 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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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