- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196023
Ca:Mg Ratio and Cognitive Function
Ca:Mg Ratio and Cognitive Function in the Personalized Prevention of Colorectal Cancer Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
- Participants who completed the MoCA
Exclusion Criteria:
1. Participants did not provide their blood samples in the parent study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: GG genotype and magnesium treatment
Participants who have the GG genotype will be assigned to magnesium glycinate
|
Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo Comparator: GG genotype and placebo
Participants who have the GG genotype will be assigned to placebo group
|
Oral administration of identical-appearing placebo daily for 12 weeks
|
Active Comparator: GA/AA genotype and magnesium treatment
Participants who have the GA/AA genotype will be assigned to magnesium glycinate
|
Oral administration of magnesium glycinate daily for 12 weeks
|
Placebo Comparator: GA/AA genotype and Placebo
Participants who have the GA/AA genotype will be assigned to placebo group
|
Oral administration of identical-appearing placebo daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: 12 weeks
|
Cognitive function was measured by the Montreal Cognitive Assessment (MoCA)
|
12 weeks
|
APOE Cytosine Modifications
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 100106a
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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