Ca:Mg Ratio and Cognitive Function

NCT ID: NCT04196023

Last Updated: 2024-05-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-12

Study Completion Date

2022-06-30

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.

Detailed Description

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Conditions

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Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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magnesium treatment

Participants will be assigned to magnesium glycinate

Group Type ACTIVE_COMPARATOR

Magnesium glycinate

Intervention Type DIETARY_SUPPLEMENT

Oral administration of magnesium glycinate daily for 12 weeks

Placebo

Intervention Type DIETARY_SUPPLEMENT

Oral administration of identical-appearing placebo daily for 12 weeks

placebo

Participants will be assigned to placebo group

Group Type PLACEBO_COMPARATOR

Magnesium glycinate

Intervention Type DIETARY_SUPPLEMENT

Oral administration of magnesium glycinate daily for 12 weeks

Placebo

Intervention Type DIETARY_SUPPLEMENT

Oral administration of identical-appearing placebo daily for 12 weeks

Interventions

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Magnesium glycinate

Oral administration of magnesium glycinate daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oral administration of identical-appearing placebo daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1\. Participants did not provide their blood samples in the parent study.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Qi Dai

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 32280092 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01CA149633

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA202936

Identifier Type: NIH

Identifier Source: secondary_id

View Link

100106a

Identifier Type: -

Identifier Source: org_study_id

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