Ca:Mg Ratio and Cognitive Function

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04196023
Collaborator
(none)
123
4
114.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Magnesium glycinate
  • Dietary Supplement: Placebo
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Ca:Mg Ratio and Cognitive Function in the Personalized Prevention of Colorectal Cancer Trial
Actual Study Start Date :
Dec 12, 2012
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: GG genotype and magnesium treatment

Participants who have the GG genotype will be assigned to magnesium glycinate

Dietary Supplement: 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

Dietary Supplement: Placebo
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

Dietary Supplement: 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

Dietary Supplement: Placebo
Oral administration of identical-appearing placebo daily for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. Cognitive function [12 weeks]

    Cognitive function was measured by the Montreal Cognitive Assessment (MoCA)

  2. APOE Cytosine Modifications [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Qi Dai, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT04196023
Other Study ID Numbers:
  • 100106a
First Posted:
Dec 12, 2019
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 27, 2022