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Completed

NCT Number: NCT04196023

Ca:Mg Ratio and Cognitive Function

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.

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Key information

Conditions

Cognitive Function

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Magnesium glycinate

Dietary Supplement

Oral administration of magnesium glycinate daily for 12 weeks

Placebo

Dietary Supplement

Oral administration of identical-appearing placebo daily for 12 weeks

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2019
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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