RecruitingACTRN12613000510741

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.


Sponsor

Blackmores Ltd

Enrollment

32 participants

Start Date

Mar 25, 2013

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is exploring whether extracts from an Australian native fruit called Davidson Plum have anti-inflammatory and antioxidant effects in healthy adults. The Davidson Plum is grown commercially and has shown promising health properties in laboratory studies. Participants will take the extract for two weeks and be measured on markers of inflammation, antioxidant activity, lung function, grip strength, mood, and quality of life. Both smokers and non-smokers are welcome. You may be eligible if: - You are between 18 and 60 years old - You are generally healthy with no current acute or chronic disease - You are willing to have blood taken twice during the study You may NOT be eligible if: - You have diabetes (Type 1 or Type 2) - You have an acute or chronic illness - You take warfarin or other blood thinners (low-dose aspirin is okay) - You take anti-depressants or anxiety medications (multiple drugs or started in the past 6 months) - You are pregnant, planning to become pregnant, or breastfeeding - You drink more than 30 standard alcoholic drinks per week - You have participated in another clinical trial in the past 30 days Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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)

NSW, Australia

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ACTRN12613000510741