Study Results
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View full resultsBasic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2012-12-12
2022-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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magnesium treatment
Participants will be assigned to magnesium glycinate
Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks
Placebo
Oral administration of identical-appearing placebo daily for 12 weeks
placebo
Participants will be assigned to placebo group
Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks
Placebo
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
Placebo
Oral administration of identical-appearing placebo daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
2. Participants who completed the MoCA
Exclusion Criteria
40 Years
85 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Qi Dai
Professor of Medicine
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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