Cognitive FunctionNCT04196023

Ca:Mg Ratio and Cognitive Function

A study testing Magnesium glycinate in people with Cognitive Function, run by Vanderbilt University Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Between 2000 and 2015, mortality due to Alzheimer's disease (AD) increased by 123%. No drugs have yet been approved to stop or slow the progression of AD. A delay of five years in the expression of AD would reduce the incidence rate by half. Read more about this study

Who is it for?: Ages 40 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Cognitive Function
What is being tested?: Magnesium glycinate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: No sites listed yet
Study dates: 12 Dec 2012to 30 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
Participants who completed the MoCA

Who cannot join

1. Participants did not provide their blood samples in the parent study.

About this study

Official title: Ca:Mg Ratio and Cognitive Function in the Personalized Prevention of Colorectal Cancer Trial

As an ancillary study conducted within a precision-based randomized trial (R01CA149633; PI, Dai \& Yu]"), the investigators reduced Ca:Mg ratios to 2.3 through 3-month personalized Mg supplementation among those who consumed high Ca:Mg ratio diet, but otherwise in good general health. The investigators test the hypothesis that actively reducing the Ca:Mg ratio among those aged >65 years who consume high Ca:Mg ratio diets improves cognitive function compared to the placebo arm. The investigators further conduct molecular epidemiologic studies to understand the molecular mechanisms.

Conditions: Cognitive Function
Being tested: Magnesium glycinate, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Magnesium glycinateDietary supplement
Oral administration of magnesium glycinate daily for 12 weeks
PlaceboDietary supplement
Oral administration of identical-appearing placebo daily for 12 weeks

Study groups in NCT04196023
Study group	Role	What they receive
magnesium treatment	Active comparator	Participants will be assigned to magnesium glycinate Receives: Dietary Supplement: Magnesium glycinate; Dietary Supplement: Placebo
placebo	Placebo comparator	Participants will be assigned to placebo group Receives: Dietary Supplement: Magnesium glycinate; Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning.
The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Measured: 12 weeks
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged ≤65 Years Old)
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning.
The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Measured: 12 weeks
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old)
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning.
The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Measured: 12 weeks
Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo
5-mC methylation (CpG sites) in Apolipoprotein E (APOE) were measure by TET-assisted bisulfite (TAB)-Array.
5-mC methylation changes=value at 12 weeks minus value at baseline.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201230 Jun 2022

First posted12 Dec 2019
Study start12 Dec 2012
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cognitive FunctionStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04196023
Sponsor's protocol ID: 100106a
Other IDs: R01CA149633, R01CA202936
Status last verified: Apr 2024
First submitted: 10 Dec 2019
Last updated: 21 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Zhu X, Borenstein AR, Zheng Y, Zhang W, Seidner DL, Ness R, Murff HJ, Li B, Shrubsole MJ, Yu C, Hou L, Dai Q. Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial. J Alzheimers Dis. 2020;75(1):85-98. doi: 10.3233/JAD-191223.
PubMed 32280092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cognitive Function trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ca:Mg Ratio and Cognitive Function in the Personalized Prevention of Colorectal Cancer Trial
ClinicalTrials.gov ID: NCT04196023
Acronym / sponsor ID: 100106a
Conditions: Cognitive Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 12 Dec 2012 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 12 Dec 2019 (actual)
Results: Posted 21 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
magnesium treatment	Active comparator	Dietary Supplement: Magnesium glycinate, Dietary Supplement: PlaceboParticipants will be assigned to magnesium glycinate
placebo	Placebo comparator	Dietary Supplement: Magnesium glycinate, Dietary Supplement: PlaceboParticipants will be assigned to placebo group

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
Participants who completed the MoCA

Key exclusion criteria (1 listed)

1. Participants did not provide their blood samples in the parent study.

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 glycinateOral administration of magnesium glycinate daily for 12 weeks	Dietary supplement	magnesium treatment, placebo
PlaceboOral administration of identical-appearing placebo daily for 12 weeks	Dietary supplement	magnesium treatment, placebo

Primary outcome

Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo
Time frame: 12 weeks
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged ≤65 Years Old)
Time frame: 12 weeks
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old)
Time frame: 12 weeks
Montreal Cognitive Assessment (MoCA) Scoring: The test consists of 30 items, and each item is worth one point, resulting in a maximum score of 30. A higher score indicates better cognitive functioning. The changes of MoCA score=Score at 12 weeks minus Score at baseline.
Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo
Time frame: 12 weeks
5-mC methylation (CpG sites) in Apolipoprotein E (APOE) were measure by TET-assisted bisulfite (TAB)-Array. 5-mC methylation changes=value at 12 weeks minus value at baseline.

Results and safety

Results posted to the registry on 21 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Were Assigned to Magnesium Glycinate	62	59
Participants Were Assigned to Placebo	67	64

Primary outcome: Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Participants Were Assigned to Magnesium Glycinate n = 59	Participants Were Assigned to Placebo n = 64
Value	1.1 (2.3)	0.6 (2.6)

Participants Were Assigned to Magnesium Glycinate vs Participants Were Assigned to Placebo: p = 0.20, general linear model

Population analysed: IRB approval was obtained to add the MoCA component on Dec.11 2012. From Dec. 12, 2012 to Jan 30, 2016, 129 participants enrolled the study. Among them, 123 (95.3%) completed pre-and post- treatment MoCA were included in the analysis.

Primary outcome: Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged ≤65 Years Old)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Participants Were Assigned to Magnesium Glycinate n = 44	Participants Were Assigned to Placebo n = 49
Value	0.7 (2.0)	0.6 (2.8)

Participants Were Assigned to Magnesium Glycinate vs Participants Were Assigned to Placebo: p = 0.90, general linear model

Population analysed: 123 participants who completed both pre- and post-treatment MoCA tests are included in the analysis.

Primary outcome: Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Participants Were Assigned to Magnesium Glycinate n = 15	Participants Were Assigned to Placebo n = 15
Value	2.3 (2.7)	0.5 (1.9)

Participants Were Assigned to Magnesium Glycinate vs Participants Were Assigned to Placebo: p = 0.01, general linear model

Population analysed: 123 participants who completed pre-and post- treatment MoCA were included in the analysis.

Primary outcome: Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo

Time frame: 12 weeks. Mean (Standard Deviation). Unit: CpG sites

Measure	Participants Were Assigned to Magnesium Glycinate n = 59	Participants Were Assigned to Placebo n = 64
cg18768621	0.006 (0.025)	-0.003 (0.025)
cg13496662	-0.018 (0.060)	0.006 (0.067)

Participants Were Assigned to Magnesium Glycinate vs Participants Were Assigned to Placebo: p = 0.05, general linear model

Population analysed: 123 participants who completed both pre- and post-treatment MoCA tests were included in the analysis.

Adverse events

Time frame: In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Were Assigned to Magnesium Glycinate	0 of 62 (0%)	4 of 62 (6.5%)	0 of 62
Participants Were Assigned to Placebo	0 of 67 (0%)	2 of 67 (3%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32280092Zhu X, Borenstein AR, Zheng Y, Zhang W, Seidner DL, Ness R, Murff HJ, Li B, Shrubsole MJ, Yu C, Hou L, Dai Q. Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial. J Alzheimers Dis. 2020;75(1):85-98. doi: 10.3233/JAD-191223.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium glycinate in people with Cognitive Function, run by Vanderbilt University Medical Center.

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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04196023, which also lists 1 linked publication.

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 21 May 2024.