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: 1. anxiety and mood as measured by the Hamilton Anxiety Rating Scale (HAM-A) and the Positive and Negative Affect Schedule (PANAS). For the HAM-A, total score and sub-scores anxious mood, tension, fears, insomnia and intellectual will be utilized. 2. quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI). 3. cognitive abilities as measured by the Erikson Flanker Task and computerized cognitive tests including Short-Term Memory Test (STM), Working Memory Test (WM), cued name recall task and face-name association task. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
50
nutritional product
Miami Research Associates
Miami, Florida, United States
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.
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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