Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000510741
Ethics application status
Approved
Date submitted
30/04/2013
Date registered
8/05/2013
Date last updated
8/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open-label exploratory study of the biological activity of an Australian native food – Davidson Plum.
Scientific title
Open-label exploratory study of the biological activity of an Australian native food, Davidson Plum, in healthy Australian adults.
Secondary ID [1] 282347 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antioxidant status 288909 0
Condition category
Condition code
Alternative and Complementary Medicine 289250 289250 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 286968 0
Other interventions
Comparator / control treatment
Nil comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289360 0
Antioxidant marker (dROMS): capillary blood sample (finger prick) analysed using Free Radical Analytical System (FRAS) 4 (Evolvo)
Timepoint [1] 289360 0
Baseline (T1) and completion (T2)
Primary outcome [2] 289526 0
C-Reactive Protein (CRP): analysis via serum assay
Timepoint [2] 289526 0
Baseline (T1) and completion (T2)
Primary outcome [3] 289527 0
Erythrocyte Sedimentation Rate (ESR): analysis via serum assay
Timepoint [3] 289527 0
Baseline (T1) and completion (T2)
Secondary outcome [1] 302305 0
Blood Glucose
Timepoint [1] 302305 0
Baseline and at 2 weeks from commencement
Secondary outcome [2] 302306 0
Full Blood Count
Timepoint [2] 302306 0
Baseline and at 2 weeks from commencement
Secondary outcome [3] 302307 0
Liver Function Test (LFT)
Timepoint [3] 302307 0
Baseline and at 2 weeks from commencement
Secondary outcome [4] 302308 0
Urea, Creatinine and Electrolytes (UEC): Serum assay
Timepoint [4] 302308 0
Baseline and at 2 weeks from commencement
Secondary outcome [5] 302309 0
Methylglyoxal: serum assay
Timepoint [5] 302309 0
Baseline and at 2 weeks from commencement
Secondary outcome [6] 302310 0
Homocysteine: serum assay
Timepoint [6] 302310 0
Baseline and at 2 weeks from commencement
Secondary outcome [7] 302311 0
Blood Pressure: automatic sphygomanometer
Timepoint [7] 302311 0
Baseline and at 2 weeks from commencement
Secondary outcome [8] 302312 0
Grip Strength: handgrip dynamometer
Timepoint [8] 302312 0
Baseline & 2 weeks from commencement
Secondary outcome [9] 302313 0
Salivary pH: "Metagenics" pH test strips
Timepoint [9] 302313 0
Baseline & 2 weeks from commencement
Secondary outcome [10] 302314 0
Profile of Mood States (POMS)
Timepoint [10] 302314 0
Baseline and 2 weeks from commencement
Secondary outcome [11] 302315 0
Brief Fatigue Inventory
Timepoint [11] 302315 0
Baseline and 2 weeks from commencement

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Selection will be on a first come first enrolled basis with an a priori intention to ideally enrol 16 smokers and 16 non-smokers.
Participants from Lismore and the surrounding district will be recruited by advertisement in local print and electronic media.
An initial telephone screening process will identify individuals who satisfy criteria for inclusion.
Suitable candidates will attend an initial study clinic for final assessment. At this visit, candidates will undergo physical screening tests.
Informed consent will be obtained at this clinic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287103 0
Commercial sector/Industry
Name [1] 287103 0
Blackmores Ltd
Country [1] 287103 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blackmores Ltd
Address
20 Jubilee Ave
Warriewood NSW 2102
Country
Australia
Secondary sponsor category [1] 285885 0
None
Name [1] 285885 0
Address [1] 285885 0
Country [1] 285885 0

Ethics approval
Ethics application status
Approved

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39334 0
Prof Stephen Myers
Address 39334 0
NatMed-Research,
Clinical Trials Unit, Southern Cross Plant Science
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 39334 0
Australia
Phone 39334 0
61 421-612-713
Fax 39334 0
Email 39334 0
[email protected]
Contact person for public queries
Name 39335 0
Prof Stephen Myers
Address 39335 0
NatMed-Research,
Clinical Trials Unit, Southern Cross Plant Science
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 39335 0
Australia
Phone 39335 0
61 421-612-713
Fax 39335 0
Email 39335 0
[email protected]
Contact person for scientific queries
Name 39336 0
Prof Stephen Myers
Address 39336 0
NatMed-Research,
Clinical Trials Unit, Southern Cross Plant Science
Southern Cross University
PO Box 157
Lismore NSW 2480
Country 39336 0
Australia
Phone 39336 0
61 421-612-713
Fax 39336 0
Email 39336 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.