ACTRN12616001426471已完成未知
A 12 Week Open Label Trial, Assessing the Effects of Temulawak extract on Genetic Expression in overweight/obese Adult Male Volunteers
SFI Research Pty Ltd.0 个研究点目标入组 32 人开始时间: 2016年10月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •1.Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, clinical laboratory test results and ECG. Subjects who have abnormal safety laboratory test results outside of the local laboratory normal reference will be excluded from the study at the PIs discretion. One repeat test will be allowed for all out of range results.
- •2.Males 18-45 years of age
- •3.BMI between 25-35
- •4.Non-smoker/Light Smoker (less than 5 cigarettes per day).
- •5.Agree to abstain from alcohol 24 hours prior to each study visit.
- •6.Agree to all visits and procedures for the duration of the study
- •7.Agree to not include any turmeric in their diet for the 12 weeks study duration
- •8.Agree to avoid consuming spicy foods in their diet for a 3 day period before each visit
- •9.Agree not to take any dietary supplements, herbal medicines (including, but not limited to, Protein powder blends, St John’s Wort, Turmeric, Curcumin, Silymarin) vitamins, mineral, prescription and/or non-prescription drugs or medicines (including anti-inflammatory drugs) for the duration of the study. Exceptions are allowed for paracetamol as long it is noted in as a concomitant medication. Pure protein powder (e.g. 100% whey) supplements are allowed
- •10.Provide Informed Consent
- •11.Agree to use adequate birth control (barrier method of birth control or abstinence) prior to study entry and during the trial and agrees not to donate sperm, for the duration of the study
排除标准
- •1.History or current diagnosis of substance abuse that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements
- •2.History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements
- •3.Signs and symptoms of chronic and/or acute inflammation and/or infection
- •4.Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies.
- •5.A positive drug/alcohol screen
- •6.Has a history of alcohol and/or drug abuse < 12 months from Screening
- •7.History of current diagnosis of any bleeding disorders
- •8.Consumption of more than three units of alcohol in any 24 hour period for the duration of the trial (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol)
- •9.Participation in a clinical trial or has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •10.BMI > 35
- •11.BMI < 25
- •12.Current use (within the past 4 weeks) of dietary supplements, protein powder blends, herbal medicines (including St John’s Wort, Turmeric, Curcumin, Silymarin) vitamins, minerals, prescription and/or non-prescription drugs or medicines (including anti-inflammatory drugs). Otherwise potentially eligible participants, who are not consuming curcumin products, and are willing to stop current use, can be re-screened for eligibility after a 2 week washout period.
- •13.Use of anti-inflammatory medications (>2 weeks, within the past 12 weeks)
- •14.Subject has donated blood or plasma or clinically significant blood loss within 60 days to the screening visit
- •15.History of migraine.
- •16.Unwillingness or inability to follow the procedures outlined in the protocol.
- •17.Vegetarian, vegan, or other significant dietary restriction and who do not agree to consume any of the standardized food.
- •18.Subjects with known hypersensitivity to the active substance or any of the excipients
- •19.Any other condition is present that in the opinion of the investigator might jeopardize the patient's safety or ability to comply with requirements of the study.
研究者
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