Clinical Trial to Evaluate Magtein in Older Adults
A Randomized Double Blind Parallel Group Placebo Controlled Clinical Trial Evaluating the Effects of Magtein on Anxiety, Mood and Sleep Quality in Older Adults
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 16, 2015
CompletedFebruary 16, 2015
February 1, 2015
1.1 years
February 4, 2015
February 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (6)
To determine the effects of Magtein on Mood states ( as measured by the Hamilton Anxiety Rating Scale (HAM-A))
12 Weeks
To determine the effects of Magtein on Mood states ( As measured by the Positive and Negative Affect Schedule (PANAS)
12 Weeks
To determine the effects of Magtein on sleep quality (as measured by the Pittsburgh Sleep Quality Index (PSQI)
12 Weeks
4. To determine the effects of Magtein on cognitive function (as measured by the Erikson Flanker Task)
12 Weeks
4. To determine the effects of Magtein on cognitive function (as measured by computerized cognitive tests including Short-Term Memory Test (STM))
12 Weeks
- +1 more secondary outcomes
Study Arms (2)
Magnesium threonate (Magtein)
ACTIVE COMPARATORThose randomized to receive the Magtein
Placebo
PLACEBO COMPARATORThose randomized to placebo
Interventions
nutritional product
Eligibility Criteria
You may qualify if:
- Subject is aged 45 to 70 years
- Subject weighs between 50 and 100 kg.
- Subject complains of having changes in their memory and concentration abilities.
- Subject scores ≥ 12 and ≤ 28 on the Hamilton Anxiety Rating Scale (HAM-A)
- Subject scores \> 5 on the Pittsburgh Sleep Quality Index (PSQI)
- Subject scores ≥ 24 on the Mini-Mental State Examination (MMSE) for the purpose of ruling out dementia and Alzheimer's disease
- Female subject is surgically sterile, post-menopausal or agrees to use an acceptable method of birth control as defined in section 2.6.
- Subject agrees to stop taking any vitamins, minerals, or dietary/herbal supplements he/she is currently taking at least 7 days prior to randomization and to not take any vitamins, minerals or dietary/herbal supplements other than the study product until after study completion.
- Subject is willing and able to comply with the protocol including:
- attending 4 visits, each of which are about 3 hours long;
- not drinking alcohol or exercising for the 24 hours prior to the visits;
- and not taking any vitamin, mineral, dietary or herbal supplements throughout the study.
- Subject is able to understand and sign the informed consent to participate in the study.
You may not qualify if:
- Subject has any of the following medical conditions:
- active heart disease
- uncontrolled high blood pressure (≥ 140/90 mmHg)
- renal or hepatic impairment/disease
- Type I or II diabetes
- bipolar disorder
- Parkinson's disease
- Alzheimer's disease
- dementia
- unstable thyroid disease
- diagnosed major affective disorder
- psychiatric disorder (hospitalized in the past year)
- immune disorder (such as HIV/AIDS)
- Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening.
- Subject is currently taking calcium channel blockers, SSRI's or anxiolytics other than benzodiazepines as needed, with "as needed" defined as less than 5 times per month.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miami Research Associates
Miami, Florida, 33143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 16, 2015
Study Start
August 1, 2012
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
February 16, 2015
Record last verified: 2015-02