Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT02363634
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.
Study:
NCT02363634
Study Brief:
Protocol Section:
NCT02363634