An interventional study of magnesium threonate in Mood and Anxiety, sponsored by Miami Research Associates. Completed at 1 site in United States. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-16.
Sponsored by Miami Research Associates · Not applicable, Interventional, and Basic science
A randomized double blind placebo controlled trial to evaluate the effects of a specialized magnesium on mood states and sleep quality in older adults.
Efficacy Objectives:
To determine the effects of 12-weeks supplementation with Magtein™ as compared to placebo on:
To determine the acute effects and the effects of 12-weeks supplementation with Magtein™ as compared to placebo on magnesium status as measured by the sponsor's protocol for determining body magnesium status.
Safety Objective:
To determine if supplementation with Magtein™ is safe within the confines of this study as denoted by changes from baseline to 12 weeks in blood work (comprehensive metabolic panel, uric acid and complete blood count with differential), blood pressure (BP), heart rate (HR), adverse events and subjective remarks.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Miami Research Associates is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subject is willing and able to comply with the protocol including:
Exclusion Criteria
Subject has any of the following medical conditions:
Subject is participating or has participated in another research study within 30 days prior to the screening visit
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Those randomized to receive the Magtein
Dietary Supplement: magnesium threonate
Those randomized to placebo
nutritional product
Also known as: Magtein
To determine the acute effects and the effects of 12-weeks supplementation with Magtein™ as compared to placebo on magnesium status as measured by the sponsor's protocol for determining body magnesium status.
To determine the acute effects and the effects of 12-weeks supplementation with Magtein™ as compared to placebo on magnesium status as measured by the sponsor's protocol for determining body magnesium status.
Time frame: 12 weeks
To determine the effects of Magtein on Mood states ( as measured by the Hamilton Anxiety Rating Scale (HAM-A))
anxiety and mood as measured by the Hamilton Anxiety Rating Scale (HAM-A). For the HAM-A, total score and sub-scores anxious mood, tension, fears, insomnia and intellectual will be utilized.
Time frame: 12 Weeks
To determine the effects of Magtein on Mood states ( As measured by the Positive and Negative Affect Schedule (PANAS)
anxiety and mood as measured by the Positive and Negative Affect Schedule (PANAS).
Time frame: 12 Weeks
To determine the effects of Magtein on sleep quality (as measured by the Pittsburgh Sleep Quality Index (PSQI)
quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).
Time frame: 12 Weeks
4. To determine the effects of Magtein on cognitive function (as measured by the Erikson Flanker Task)
cognitive abilities as measured by the Erikson Flanker Task
Time frame: 12 Weeks
4. To determine the effects of Magtein on cognitive function (as measured by computerized cognitive tests including Short-Term Memory Test (STM))
cognitive abilities as measured by computerized cognitive tests including Short-Term Memory Test (STM), Working Memory Test (WM), cued name recall task and face-name association task.
Time frame: 12 Weeks
To determine relative safety of Magtein with 12 weeks use
To determine if supplementation with Magtein™ is safe within the confines of this study as denoted by changes from baseline to 12 weeks in blood work (comprehensive metabolic panel, uric acid and complete blood count with differential), blood pressure (BP), heart rate (HR), adverse events and subjective remarks.
Time frame: 12 Weeks
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Miami Research Associates