Pharmacokinetics of ingested Ursolic Acid supplements in healthy me

Phase 1

• Conditions: muscle wasting; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12618001763235
• Lead Sponsor: Garvan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

•Healthy men aged between 18-35 years
•A BMI >18 and <27.99 kg/m2

Exclusion Criteria

•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)
•Epilepsy
•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

Study & Design

• Study Type: Interventional
• Study Design: Not specified