ACTRN12611000092998招募中未知
Randomized clinical trial investigating effects of a multi-nutrient combination on mood, stress, sleep and cognition in healthy young adults
Swisse Vitamins Pty Ltd0 个研究点目标入组 160 人开始时间: 2011年1月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 160
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
- 25 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.Healthy non-smoking males and females aged between 25 and 45 years.
- •2.Currently in at least part-time employment and/or a student in higher education or TAFE.
- •3.No history of anxiety, depression, psychiatric disorders or epilepsy
- •4.No history of / do not currently suffer from heart disease or high blood pressure or diabetes.
- •5.Not taking any medication, herbal extracts, vitamin supplements or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) study.
- •6.Not 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
- •7.No 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)
- •8.Not pregnant or possibility of being pregnant
- •9.No hearing impairment
- •10.Not allergic to gluten/wheat
- •11.Are willing and able to participate in all scheduled visits, treatment plan, dietary restrictions, tests and other trial procedures according to the protocol. Also comfortable with computers.
- •12.Are willing to provide blood samples throughout the testing phases
- •13.Understand the rating scales and computer tests (as judged by the study coordinator)
- •14.Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
排除标准
- •1.Cigarette smoker
- •2.Heavy drinker of alcohol (averages more than 2 standard drinks per day).
- •3.Diagnosis of Type 1 or Type 2 diabetes
- •4.History of anxiety, depression, psychiatric disorders or epilepsy
- •5.History of / currently suffers from heart disease or high blood pressure.
- •6.Evidence or history of any clinically significant (in the judgment of the investigator) renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, within the last 5 years
- •7.Use of any over-the-counter herbal extracts, vitamin supplements and/or other dietary supplements which might influence cognition or mood for four weeks prior to the practice day
- •8.Currently taking any illicit drugs and/or a history of substance abuse.
- •9.Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. have Irritable bowel syndrome, peptic ulcers)
- •10.Pregnant or possibility of being pregnant
- •11.Allergy to gluten/wheat
- •12.Hearing impairment
- •13.Are not willing to provide blood samples throughout the testing phases
- •14.Current participation in any other trials involving investigational or marketed products within 30 days prior to the practice day.
- •15.History of head injury/stroke
- •16.Any clinically relevant abnormalities in a volunteer’s medical history, physical examination, or results of laboratory tests.
- •17.Currently taking Warfarin
研究者
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