MoodNCT02363634
Clinical Trial to Evaluate Magtein in Older Adults
A study testing magnesium threonate in people with Mood and Anxiety, run by Miami Research Associates at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- What is being tested?
- magnesium threonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
- 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.
- Subject is currently taking any medications that are known to interact with magnesium (see section 2.5.2).
- Subject is currently taking antibiotics as the study product may reduce the absorption of antibiotics. A washout period of 2 weeks is allowed.
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Subject is currently taking any medication deemed exclusionary by PI.
- Subject has an allergy or sensitivity to any ingredient in the test product (see section 3.2.1).
- 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.
- Subject has a history of drug or alcohol abuse in the past 12 months.
- Subject has begun/stopped smoking ≤ 6 months ago OR has plans to begin/quit smoking.
- Subject is pregnant, lactating, or planning to become pregnant during the study period.
- 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.
- Subject is participating or has participated in another research study within 30 days prior to the screening visit
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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.
- quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).
- 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.
- Being tested
- magnesium threonate
- Keywords
- magnesium status, sleep quality
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium threonateDietary supplement
Also called Magtein
nutritional product
| Study group | Role | What they receive |
|---|---|---|
| Magnesium threonate (Magtein) | Active comparator | Those randomized to receive the Magtein Receives: Dietary Supplement: magnesium threonate |
| Placebo | Placebo comparator | Those randomized to placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 12 Weeks
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).
Measured: 12 Weeks
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).
Measured: 12 Weeks
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
Measured: 12 Weeks
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.
Measured: 12 Weeks
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miami Research Associates
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363634
- Sponsor's protocol ID
- AIDP-Mg-2012
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02363634
- Acronym / sponsor ID
- AIDP-Mg-2012
- Keywords
- magnesium status, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Miami Research AssociatesResearch network
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium threonate (Magtein) | Active comparator | Dietary Supplement: magnesium threonateThose randomized to receive the Magtein |
| Placebo | Placebo comparator | –Those randomized to placebo |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (28 listed)
- Subject has any of the following medical conditions:
- 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.
- Subject is currently taking any medications that are known to interact with magnesium (see section 2.5.2).
- Subject is currently taking antibiotics as the study product may reduce the absorption of antibiotics. A washout period of 2 weeks is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium threonateAlso: Magteinnutritional product | Dietary supplement | Magnesium threonate (Magtein) |
Primary outcome
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
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.
6 secondary outcomes
To determine the effects of Magtein on Mood states ( as measured by the Hamilton Anxiety Rating Scale (HAM-A))
Time frame: 12 Weeks
To determine the effects of Magtein on Mood states ( As measured by the Positive and Negative Affect Schedule (PANAS)
Time frame: 12 Weeks
To determine the effects of Magtein on sleep quality (as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 Weeks
4. To determine the effects of Magtein on cognitive function (as measured by the Erikson Flanker Task)
Time frame: 12 Weeks
4. To determine the effects of Magtein on cognitive function (as measured by computerized cognitive tests including Short-Term Memory Test (STM))
Time frame: 12 Weeks
To determine relative safety of Magtein with 12 weeks use
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnesium threonate in people with Mood and Anxiety, run by Miami Research Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.