NCT02363634已完成不适用
A Randomized Double Blind Parallel Group Placebo Controlled Clinical Trial Evaluating the Effects of Magtein on Anxiety, Mood and Sleep Quality in Older Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
A randomized double blind placebo controlled trial to evaluate the effects of a specialized magnesium on mood states and sleep quality in older adults.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
Placebo
Placebo Comparator
Those randomized to placebo
Magnesium threonate (Magtein)
Active Comparator
Those randomized to receive the Magtein
干预措施: magnesium threonate (Dietary Supplement)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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 sleep quality (as measured by the Pittsburgh Sleep Quality Index (PSQI)(12 Weeks)
- To determine relative safety of Magtein with 12 weeks use(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)
- To determine the effects of Magtein on Mood states ( As measured by the Positive and Negative Affect Schedule (PANAS)(12 Weeks)
研究者
研究点 (1)
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