N/A
N=129
Ca:Mg Ratio and Cognitive Function
Cognitive Function
Bottom Line
View on ClinicalTrials.gov: NCT04196023 ↗Enrolled (actual)
129
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo — 1.1; 0.6 score on a scale — p=0.20
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnesium glycinate (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo |
1.1; 0.6 | 0.20 |
| PRIMARY Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged ≤65 Years Old) |
0.7; 0.6 | 0.90 |
| PRIMARY Overall Score Changes From Baseline by Magnesium Treatment vs. Placebo (Aged >65 Years Old) |
2.3; 0.5 | 0.01 sig |
| PRIMARY Changes From Baseline of 5-mC Methylation (CpG Sites) in Apolipoprotein E (APOE) by Magnesium Treatment vs. Placebo |
0.006; -0.003; -0.018; 0.006 | 0.05 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04196023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.