None listed
Conditions
Brief summary
Muscle wasting, or atrophy, is a widespread problem in elderly human populations, and greatly increases the chances of falls and metabolic diseases such as type 2 diabetes. Ursolic acid (UA) is a natural food-derived nutrient (found in many herbs such as Rosmarinus officinalis (rosemary), Origanum vulgare (oregano), and the peel of fruits such as apples) has been shown in rodents to prevent muscle atrophy and promote muscle growth. However, the bioavailability, safety and tolerability of orally ingested ursolic acid in humans is not fully known. Therefore, our aims for this study are: To determine the bio-availability, safety and tolerability of 3 different forms of orally ingested Ursolic Acid in healthy men. We hypothesise that UA will be adequately absorbed to elicit a measurable appearance in the blood and expect to see the greatest bioavailability of UA from the UA-Oil > UA-Phy > UA-Pow, with no severe adverse events, safety or tolerability complications with any of the UA supplements taken.
Interventions
In a double-blind, randomised, cross-over design study to evaluate the bio-availability Ursolic Acid in three different forms.
Ursolic Acid will be ingested orally on 3 separate occasions with a minimum 7day wash-out period in between doses. The study personnel will directly observe the participant ingesting the dose.
The 3 single doses of ursolic acid will each contain 200mg ursolic acid within a capsule and will be indistinguishable from one-another, but with the following differences:
• UA-P
In a double-blind, randomised, cross-over design study to evaluate the bio-availability Ursolic Acid in three different forms. Ursolic Acid will be ingested orally on 3 separate occasions with a minimum 7day wash-out period in between doses. The study personnel will directly observe the participant ingesting the dose. The 3 single doses of ursolic acid will each contain 200mg ursolic acid within a capsule and will be indistinguishable from one-another, but with the following differences: • UA-Pow; capsule containing 200mg Ursolic acid in powder form • UA-Phy; capsule containing 200mg Ursolic Acid within Phytosomes • UA-Oil; capsule containing 200mg Ursolic Acid within Phytosomes suspended in oil
Sponsors
Garvan Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Outcome results
None listed