ACTRN12612001116819已完成4 期
Acute effects of multi-vitamin/mineral preparations on brain imaging assessed with steady state tomography and fMRI during periods of mental effort in healthy adults aged 18-40 years
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
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. Must be right-handed
排除标准
- •1. History of anxiety, depression, psychiatric disorders.
- •2. Currently suffering from/ or have history of heart disease or high blood pressure or diabetes
- •3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study
- •4. Taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
- •5. 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)
- •6. Epilepsy/Photosensitive or unable to look at flashing lights
- •7. Left handed participants. 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.
- •8. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder),
- •9. Currently pregnant or lactating
- •10. People with metal implants (for MRI component)
研究者
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