Open-label exploratory study of the biological activity of an Australian native food – Davidson Plum.

Not Applicable

Recruiting

• Conditions: Antioxidant status; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12613000510741
• Lead Sponsor: Blackmores Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antioxidant marker (dROMS): capillary blood sample (finger prick) analysed using Free Radical Analytical System (FRAS) 4 (Evolvo)[Baseline (T1) and completion (T2)];C-Reactive Protein (CRP): analysis via serum assay[Baseline (T1) and completion (T2)];Erythrocyte Sedimentation Rate (ESR): analysis via serum assay[Baseline (T1) and completion (T2)]

Secondary Outcome Measures

Name	Time	Method
Blood Glucose[Baseline and at 2 weeks from commencement ];Full Blood Count[Baseline and at 2 weeks from commencement ];Liver Function Test (LFT)[Baseline and at 2 weeks from commencement ];Urea, Creatinine and Electrolytes (UEC): Serum assay[Baseline and at 2 weeks from commencement ];Methylglyoxal: serum assay[Baseline and at 2 weeks from commencement ];Homocysteine: serum assay[Baseline and at 2 weeks from commencement ];Blood Pressure: automatic sphygomanometer[Baseline and at 2 weeks from commencement ];Grip Strength: handgrip dynamometer[Baseline & 2 weeks from commencement];Salivary pH: Metagenics pH test strips [Baseline & 2 weeks from commencement];Profile of Mood States (POMS)[Baseline and 2 weeks from commencement];Brief Fatigue Inventory[Baseline and 2 weeks from commencement]