Cognitive FunctionNCT07685613
A Virtual Clinical Trial to Examine the Effect of Magnesium Choline Citrate on Cognitive Function and Anxiety in Healthy Adolescents and Adults
A study testing Magnesium Choline Citrate in people with Cognitive Function and Anxiety, run by Nutrisol, LLC at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Anxiety
- What is being tested?
- Magnesium Choline Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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?
Read more
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
- Conditions
- Cognitive Function, Anxiety
- Being tested
- Magnesium Choline Citrate, Placebo
- Keywords
- Cognitive Function, Anxiety, Magnesium Choline Citrate
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Choline CitrateDietary supplement
Participants will be instructed to take two capsules twice per day with food starting on Day 1.
PlaceboDietary supplement
Participants will be instructed to take two capsules twice per day with food starting on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Choline Citrate | Experimental | Not described Receives: Dietary Supplement: Magnesium Choline Citrate |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (9-17 years old) from baseline to Day 84 between Magnesium Choline Citrate and placebo
Measured: Baseline (day 1) to day 84
Secondary outcomes (4)
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
Measured: Baseline (day 1) to day 42
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
Measured: 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
Measured: 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 (9-17 years old) from baseline to Days 42 and 84 between Magnesium Choline Citrate and placebo
Measured: Baseline (day 1) to days 42 and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrisol, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685613
- Sponsor's protocol ID
- 25NSRDM03
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07685613
- Acronym / sponsor ID
- 25NSRDM03
- Conditions
- Cognitive Function, Anxiety
- Keywords
- Cognitive Function, Anxiety, Magnesium Choline Citrate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nutrisol, LLCIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Choline Citrate | Experimental | Dietary Supplement: Magnesium Choline Citrate |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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,
- 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
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Choline CitrateParticipants will be instructed to take two capsules twice per day with food starting on Day 1. | Dietary supplement | Magnesium Choline Citrate |
| PlaceboParticipants will be instructed to take two capsules twice per day with food starting on Day 1 | Dietary supplement | Placebo |
Primary outcome
PROMIS Cognitive Function- Short Form 8a (baseline to day 84)
Time frame: 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
Pediatric Cognitive Function - Short Form 7a (baseline to day 84)
Time frame: Baseline (day 1) 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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Choline Citrate in people with Cognitive Function and Anxiety, run by Nutrisol, LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (1-226-242-4551 ext. 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Cognitive Function- Short Form 8a (baseline to day 84) (time frame: Baseline (day 1) to day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.