Clinical Trial to Evaluate Magtein in Older Adults

Anxiety Clinical Trial

Official title: A Randomized Double Blind Parallel Group Placebo Controlled Clinical Trial Evaluating the Effects of Magtein on Anxiety, Mood and Sleep Quality in Older Adults

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety
• Mood

• NCT number: NCT02363634
• Study type: Interventional
• Source: Miami Research Associates
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Completion date: November 2013