Ca:Mg Ratio and Cognitive Function

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196023
• Other study ID #: 100106a
• Secondary ID: R01CA149633R01CA
• Status: Completed
• Phase: N/A
• Start date: December 12, 2012
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Dietary Supplement:
• Magnesium glycinate
Oral administration of magnesium glycinate daily for 12 weeks
• Placebo
Oral administration of identical-appearing placebo daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI)

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo	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.	12 weeks
Primary	Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged =65 Years Old)	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.	12 weeks
Primary	Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old)	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.	12 weeks
Primary	Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo	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.	12 weeks