Ca:Mg Ratio and Cognitive Function

NCT04196023 | Completed Results

• 3 other identifiers: 100106aR01CA149633R01CA202936
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Function

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

magnesium treatment

ACTIVE COMPARATOR

Participants will be assigned to magnesium glycinate

Dietary Supplement: Magnesium glycinate; Dietary Supplement: Placebo

placebo

PLACEBO COMPARATOR

Participants will be assigned to placebo group

Dietary Supplement: Magnesium glycinate; Dietary Supplement: Placebo

Interventions

Magnesium glycinate DIETARY_SUPPLEMENT

Oral administration of magnesium glycinate daily for 12 weeks

magnesium treatment; placebo

Placebo DIETARY_SUPPLEMENT

Oral administration of identical-appearing placebo daily for 12 weeks

magnesium treatment; placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants from our parent study (Personalized Prevention of Colorectal Cancer Trial, NCT#01105169, IRB#100106);
• Participants who completed the MoCA

You may not qualify if:

• \. Participants did not provide their blood samples in the parent study.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Cancer Institute (NCI): collaborator

Related 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.

  PMID: 32280092 BACKGROUND

MeSH Terms

Interventions

magnesium diglycinate

Results Point of Contact

• Title: Dr. Qi Dai
• Organization: Vanderbilt University Medical Center

qi.dai@vanderbilt.edu

(615)936-0707

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: December 12, 2012
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-04