ACTRN12618001763235尚未招募1 期
Pharmacokinetics of ingested Ursolic Acid supplements in healthy men
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 8
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
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 35 Years（—）
- 性别
- Male
入选标准
- •Healthy men aged between 18-35 years
- •A BMI >18 and <27.99 kg/m2
排除标准
- •A BMI < 17.99 or > 28 kg/m2
- •Active cardiovascular disease: uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event
- •Clinically significant (>2 × upper limit of normal [ULN]) abnormal blood test result at screening for any metabolite measured from: Full Blood Count, Urea & Electrolytes, Thyroid Function Tests, Coagulation Tests, Liver Function Tests, glucose, insulin, HbA1c, DBIL, TBIL, phosphate, calcium and Creatine Kinase.
- •Taking beta-adrenergic blocking agents, statins or non-steroidal anti-inflammatory drugs
- •Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)
- •Respiratory disease including pulmonary hypertension, COPD, asthma or an FEV1 less than 1.5L
- •Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing’s disease, types 1 or 2 diabetes
- •Active inflammatory bowel or renal disease
- •Malignancy
- •Recent steroid treatment (within 6 months), or hormone replacement therapy
- •Family history of early (<55y) death from cardiovascular disease
- •Taking any prescription/ non-prescription medication / supplements that in the opinion of the CI or PI might interact with or impact UA absorption or metabolism
- •Current or recent (last 30 days) smoker
- •Known or possible sensitivity to Ursolic Acid (allergy to apples, rosemary plant, holy basil or bearberry).
- •Planned surgery during the course of the trial;
- •History of or current diagnosis of any cancer (except successfully treated basal cell carcinoma or cancer in full remission >5 years after diagnosis);
- •History of blood/bleeding disorders;
- •Participation in another clinical research trial within 30 days before randomization
研究者
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