Ca:Mg Ratio and Cognitive Function

Study Overview
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Brief Summary
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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. Thus, it is critical to develop novel prevention strategies to delay the onset of this common disease. 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.

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

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Magnesium glycinate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106); Participants who completed the MoCA Exclusion Criteria: 1. Participants did not provide their blood samples in the parent study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GG genotype and magnesium treatment<br>Participants who have the GG genotype will be assigned to magnesium glycinate | Dietary Supplement: Magnesium glycinate<br>* Oral administration of magnesium glycinate daily for 12 weeks<br>|
| Placebo Comparator: GG genotype and placebo<br>Participants who have the GG genotype will be assigned to placebo group | Dietary Supplement: Placebo<br>* Oral administration of identical-appearing placebo daily for 12 weeks<br>|
| Active Comparator: GA/AA genotype and magnesium treatment<br>Participants who have the GA/AA genotype will be assigned to magnesium glycinate | Dietary Supplement: Magnesium glycinate<br>* Oral administration of magnesium glycinate daily for 12 weeks<br>|
| Placebo Comparator: GA/AA genotype and Placebo<br>Participants who have the GA/AA genotype will be assigned to placebo group | Dietary Supplement: Placebo<br>* Oral administration of identical-appearing placebo daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Cognitive function was measured by the Montreal Cognitive Assessment (MoCA) | 12 weeks | 
| APOE Cytosine Modifications |  | 12 weeks |