CTRI/2022/03/041219已完成3 期
A prospective, double-blind, randomized, cross-over, four arm, four treatments, two period, placebo-controlled study to evaluate the taste, memory/cognition and anxiety effects of 2 different doses of paraxanthine (PX) in comparison to that of caffeine (CF) in otherwise healthy volunteers
Ingenious Ingredients0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Subject has provided written and dated informed consent to participate in the study.
- •2.Subject is willing and able to comply with the protocol.
- •3.Subject is a male/female between 18 and 55 years of age.
排除标准
- •1.Subject is a slow caffeine metabolizer [determined by genome testing regarding the enzyme in the liver that metabolizes caffeine, p450 1A2 (CYP1A2)].
- •2.Subject is participating in another clinical trial or has received an investigational product within thirty days prior to enrollment.
- •3.Subject has a history of alcohol or other drug abuse in the past year.
- •4.Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, high blood pressure (BP) [systolic BP > 140 and/or diastolic BP > 90], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •5.Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical anxiety, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
- •6.Subject has a known allergy or sensitivity to any ingredient in the test product.
- •7.Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •8.Investigator is uncertain about subjectââ?¬•s capability or willingness to comply with the protocol requirements.
研究者
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