Open-label exploratory study of the biological activity of an Australian native food – Davidson Plum.
Open-label exploratory study of the biological activity of an Australian native food, Davidson Plum, in healthy Australian adults.
Blackmores Ltd
32 participants
Mar 25, 2013
Interventional
Conditions
Summary
Recent investigations into a range of native Australian species grown commercially for the food industry have emphasised the need for further research into the potential health benefits of these species, in particular, Davidsonia pruriens (Davidson Plum). An open label exploratory pilot study is proposed to investigate the anti-inflammatory and antioxidant effects of an extract of Davidson Plum in humans. Additionally, a range of physical and cognitive screening tests will be trialled that incorporate known markers of health status, including lung function, grip strength, mobility impairment, mood and quality of life. It is hypothesized that the oral administration of the study medication over 2 weeks will result in a statistically significant change in markers of antioxidant and anti-inflammatory status. Both smokers and non-smokers will be enrolled. The analysis will look at the total population and then at smokers and non-smokers separately.
Eligibility
Inclusion Criteria4
- Aged 18 – 60 years
- Healthy (no current acute or chronic disease)
- Individuals willing to comply with the study protocols
- Individuals willing to have blood taken 2 times during the study
Exclusion Criteria13
- Individuals with current acute or chronic diseases
- Individuals with Type I diabetes or Type II diabetes
- Individuals taking anti-depressants/ anxiolytic medications (multiple drugs/started in the last 6 mths)
- Individuals taking Warfarin or other anti-coagulant medication, except low dose aspirin (less than or equal to 100mg)
- Individuals known to have poor venous access
- Liver function tests greater than 3 times the upper limit of normal at baseline
- Use of corticosteroids (intra-articular or systemic) within 4 weeks prior to baseline
- Individuals unwilling to cease taking vitamin/mineral supplements or other complementary medicines 2-4 weeks prior to commencement (washout phase).
- Recent history of alcohol or substance abuse; >30 std drinks per week
- Females who are lactating, pregnant or planning to become pregnant (need to be willing to use contraception across course of the trial)
- Participants who have participated in another clinical trial in the last 30 days
- Any other condition which needs to be clarified by the Study Coordinators
- Inability or unwillingness of participant or legally acceptable representative to give written informed consent
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Interventions
Aqueous extract Davidson Plum: 100mL/day to be administered orally for 2 weeks. Adherence will monitored via measurement of extract returned at completion of treatment phase.
Locations(1)
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ACTRN12613000510741