ACTRN12612001043820已完成4 期
Effects of 4 weeks supplementation with a multivitamin/mineral preparation on brain function in healthy volunteers assessed with Steady State Topography and fMRI during periods of mental effort: A randomized, double-blind, placebo controlled trial
Swinburne University0 个研究点目标入组 56 人开始时间: 2012年10月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •1.Healthy, non-smoking, males and females aged 18-40.
- •2.Are comfortable with computers, EEG (not photosensitive or sensitive to flashing lights) and fMRI and willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol.
- •3.Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
- •4.For participants in the fMRI condition, only right handed participants will be recruited
- •5.Female subjects of childbearing age using an acceptable form of contraception
- •6.Fluent in spoken and written English
排除标准
- •1. History of or currently suffering from anxiety, depression, psychiatric disorders.
- •2. History of / currently suffering from heart disease, high blood pressure or diabetes
- •3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs within 4 weeks prior to (and duration of) study (except for routine medications to treat benign conditions, such as antibiotics to treat acne), or excessive consumption of caffeine or alcohol in this period, 4. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
- •5. Epilepsy/Photosensitive or unable to look at flashing lights
- •6. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder)
- •7. Currently pregnant or lactating
- •8. Left handed participants (for fMRI component only). This is for ease of analysis looking at the fMRI. There are hemispheric differences in terms of structure between right and left handed individuals that prove to be problematic when analysing the output. Given that this investigation will employ a method where participants need to press buttons as a response (in turn involving the motor cortex), it is wise to use an all right handed population.
- •9. People with metal implants (for fMRI component only)
- •10. Vital signs out of the normal range (blood pressure, pulse rate, body temperature)
- •11. History of head trauma
- •12. Hypersensitivity to the investigational product or any of the active/inactive ingredients
- •13. Participation in another trial within 30 days prior to the start of the study.
- •14. Any condition which may interfere with the subject’s ability to perform assessments (e.g. claustrophobia for the fMRI arm, dyslexia, limb deformity).
研究者
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