Clinical Trial to Evaluate Magtein in Older Adults
- Conditions
- AnxietyMood
- Interventions
- Dietary Supplement: magnesium threonate
- Registration Number
- NCT02363634
- Lead Sponsor
- Miami Research Associates
- Brief Summary
A randomized double blind placebo controlled trial to evaluate the effects of a specialized magnesium on mood states and sleep quality in older adults.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Magnesium threonate (Magtein) magnesium threonate Those randomized to receive the Magtein
- Primary Outcome Measures
Name Time Method 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. 12 weeks 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.
- Secondary Outcome Measures
Name Time Method To determine the effects of Magtein on sleep quality (as measured by the Pittsburgh Sleep Quality Index (PSQI) 12 Weeks quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).
To determine the effects of Magtein on Mood states ( as measured by the Hamilton Anxiety Rating Scale (HAM-A)) 12 Weeks 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.
To determine relative safety of Magtein with 12 weeks use 12 Weeks 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. To determine the effects of Magtein on cognitive function (as measured by the Erikson Flanker Task) 12 Weeks cognitive abilities as measured by the Erikson Flanker Task
4. To determine the effects of Magtein on cognitive function (as measured by computerized cognitive tests including Short-Term Memory Test (STM)) 12 Weeks 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.
To determine the effects of Magtein on Mood states ( As measured by the Positive and Negative Affect Schedule (PANAS) 12 Weeks anxiety and mood as measured by the Positive and Negative Affect Schedule (PANAS).
Trial Locations
- Locations (1)
Miami Research Associates
🇺🇸Miami, Florida, United States