Ca:Mg Ratio and Cognitive Function

Not Applicable

Completed

• Conditions: Cognitive Function
• Interventions: Dietary Supplement: Magnesium glycinate; Dietary Supplement: Placebo

• Registration Number: NCT04196023
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-12-12
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2023-06-20
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Participants will be assigned to placebo group
placebo	Magnesium glycinate	Participants will be assigned to placebo group
magnesium treatment	Magnesium glycinate	Participants will be assigned to magnesium glycinate
magnesium treatment	Placebo	Participants will be assigned to magnesium glycinate

Primary Outcome Measures

Name	Time	Method
Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo	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)	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)	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	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.