ACTRN12622001511729已完成未知
An Assessment of the Safety and Efficacy of IDM01 capsules on General Fatigue and Cognitive Performance in Recreationally Active Adults: A Prospective, Interventional, Double-Blind, Placebo-Controlled Parallel Arm Clinical Study.
Clinical Research Australia0 个研究点目标入组 120 人开始时间: 2022年12月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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 50 Years（—）
- 性别
- All
入选标准
- •1) Males and females between the ages of 18 and 50 years.
- •2) Engaging in regular resistance exercise for longer than 6 months and between 3 and 5 times a week.
- •3) BMI between 18.5 and 30 kg/m2.
- •4) Normal dietary habits (no medically prescribed diet, no slimming diet, no vegan or macrobiotic diet)
- •5) Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
- •6) Non-smoker.
- •7) Willing to maintain current diet, exercise, and supplement regimen during the study period.
排除标准
- •1) History of infection in the month prior to the study
- •2) Any significant surgeries over the last year
- •3) Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
- •4) Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy
- •5) Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
- •6) Suffering from insomnia or engaged in night-shift employment and unable to have a normal night’s sleep
- •7) Currently taking (or in the previous 3 months) the following medications and/or supplements: coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
- •8) Change in medication in the last 3 months or an expectation to change during the study duration
- •9) Alcohol intake greater than 14 standard drinks (12.5ml of pure alcohol) per week
- •10) Current or 12-month history of illicit drug abuse
- •11) Consumption of more than 3 cups of coffee a day (or another equivalent caffeinated beverage)
- •12) Intake of supplements containing fenugreek
- •13) Intake of any other dietary, herbal or pharmaceutical medications with significant stimulation on the central nervous system (e.g., caffeinated supplements or stimulant medications)
- •14) Pregnant women, women who are breastfeeding, or women who intend to fall pregnant.
- •15) Allergic to any of the ingredients in active or placebo formula
- •16) Have participated in any other clinical trial during the past 3 months
- •17) Any condition that in the opinion of the investigator makes the subject unsuitable for inclusion
研究者
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