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CompletedNCT02363634Updated Feb 16, 2015

Clinical Trial to Evaluate Magtein in Older Adults

An interventional study of magnesium threonate in Mood and Anxiety, sponsored by Miami Research Associates. Completed at 1 site in United States. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-16.

Sponsored by Miami Research Associates · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mood
  • Anxiety

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Keywords

  • magnesium status
  • sleep quality
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Miami Research Associates is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subject is aged 45 to 70 years
  2. Subject weighs between 50 and 100 kg.
  3. Subject complains of having changes in their memory and concentration abilities.
  4. Subject scores ≥ 12 and ≤ 28 on the Hamilton Anxiety Rating Scale (HAM-A)
  5. Subject scores > 5 on the Pittsburgh Sleep Quality Index (PSQI)
  6. Subject scores ≥ 24 on the Mini-Mental State Examination (MMSE) for the purpose of ruling out dementia and Alzheimer's disease
  7. Female subject is surgically sterile, post-menopausal or agrees to use an acceptable method of birth control as defined in section 2.6.
  8. 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.
  9. 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.
  10. Subject is able to understand and sign the informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria

  1. 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)
    • any medical condition deemed exclusionary by the Principal Investigator (PI)
  2. Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening.
  3. 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.
  4. Subject is currently taking any medications that are known to interact with magnesium (see section 2.5.2).
  5. Subject is currently taking antibiotics as the study product may reduce the absorption of antibiotics. A washout period of 2 weeks is allowed.
  6. Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
  7. Subject is currently taking any medication deemed exclusionary by PI.
  8. Subject has an allergy or sensitivity to any ingredient in the test product (see section 3.2.1).
  9. Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or other clinically significant abnormal clinical laboratory value per PI discretion.
  10. Subject has a history of drug or alcohol abuse in the past 12 months.
  11. Subject has begun/stopped smoking ≤ 6 months ago OR has plans to begin/quit smoking.
  12. Subject is pregnant, lactating, or planning to become pregnant during the study period.
  13. Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
  14. Subject is participating or has participated in another research study within 30 days prior to the screening visit

    -

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Magnesium threonate (Magtein)

    Those randomized to receive the Magtein

    Dietary Supplement: magnesium threonate

  • Placebo comparator
    Placebo

    Those randomized to placebo

Interventions

  • Dietary supplementmagnesium threonate

    nutritional product

    Also known as: Magtein

06

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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. 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

  5. 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.

    Time frame: 12 Weeks

  6. 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

07

Study locations

1 site
  • Miami Research Associates
    Miami, Florida 33143, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02363634
Lead sponsor
Miami Research Associates
Responsible party
Sponsor
First posted
Feb 16, 2015
Start date
Aug 2012
Primary completion
Sep 2013
Completion
Nov 2013
Last update
Feb 16, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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