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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA149633 | U.S. NIH Grant/Contract | View source | |
| R01CA202936 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| magnesium treatment | Active Comparator | Participants will be assigned to magnesium glycinate |
|
| placebo | Placebo Comparator | Participants will be assigned to placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium glycinate | Dietary Supplement | Oral administration of magnesium glycinate daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Participants did not provide their blood samples in the parent study.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32280092 | Background | 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. |
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Participants, aged 40-85 y, with colorectal polyp or polyp-free individuals with high risk of colorectal cancer and had a calcium intake of ≥700 and <2000 mg/d, and their calcium-to-magnesium intake ratio was >2.6 (based on baseline two 24-hour dietary recalls) and completed MoCA assessment were recruited from Vanderbilt patient sources from Dec. 12, 2012 to Jan 30, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Were Assigned to Magnesium Glycinate | Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
| FG001 | Participants Were Assigned to Placebo | Placebo: Oral administration of identical-appearing placebo daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Will be Assigned to Magnesium Glycinate | Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
| BG001 | Participants Will be Assigned to Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | IRB approval was obtained to add the MoCA component on Dec.11 2012. From Dec. 12, 2012 to Jan 30, 2016, 129 participants enrolled the study. Among them, 123 (95.3%) completed pre-and post- treatment MoCA were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions.
We conducted safety and compliance calls to collect adverse event data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Were Assigned to Magnesium Glycinate | Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| some bleeding after the rectal biopsy procedure | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Qi Dai | Vanderbilt University Medical Center | (615)936-0707 | qi.dai@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2022 | Mar 15, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C091418 | magnesium diglycinate |
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| Placebo | Dietary Supplement | Oral administration of identical-appearing placebo daily for 12 weeks |
|
| Lost to Follow-up |
|
Placebo: Oral administration of identical-appearing placebo daily for 12 weeks
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Overall MoCA Score at Baseline | Measure Description: Cognitive function was measured by the Montreal Cognitive Assessment (MoCA) which is used to evaluate people with memory loss or other symptoms of cognitive decline. Scores on the MoCA range 0-30. Higher values represent a better outcome. A score of 26 or above is considered normal. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Participants Were Assigned to Placebo |
Placebo: Oral administration of identical-appearing placebo daily for 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. | 123 participants who completed both pre- and post-treatment MoCA tests are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 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. | 123 participants who completed pre-and post- treatment MoCA were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 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. | 123 participants who completed both pre- and post-treatment MoCA tests were included in the analysis. | Posted | Mean | Standard Deviation | CpG sites | 12 weeks |
|
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|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 4 |
| 62 |
| EG001 | Participants Were Assigned to Placebo | Placebo: Oral administration of identical-appearing placebo daily for 12 weeks | 0 | 67 | 0 | 67 | 2 | 67 |
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | abdominal pain |
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| may interact with blood pressure medication | Vascular disorders | Non-systematic Assessment |
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| weight gain, migraine and swelling with arthritic pain in fingers | General disorders | Non-systematic Assessment |
|
| feel sick | General disorders | Non-systematic Assessment |
|
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