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Trial registered on ANZCTR

Registration number

ACTRN12612000674831

Ethics application status

Approved

Date submitted

21/06/2012

Date registered

25/06/2012

Date last updated

27/06/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Role of Queen Garnet Plum in prevention of thrombotic (blood clotting) risk factors

Scientific title

Comparative effect of different antioxidant rich plums in the prevention of thrombotic risk factors by attenuating platelet activity, reducing inflammation, improving lipid profile and haemostatic function in normal healthy human population

Secondary ID [1]

'Nil'

Universal Trial Number (UTN)

U1111-1131-9945

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Oxidative stress induced metabolic syndrome

Thrombosis

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Blood

Clotting disorders

Alternative and Complementary Medicine

Other alternative and complementary medicine

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Queen Garnet Plum (QGP) is a result of a Queensland Government innovative breeding project. Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF) has shown QGP to have 5-10 times higher antioxidant levels (anthocyanins) compared to all other varieties of plums.

Arm 1:
In the first protocol of this double blind crossover study we will compare the effect of 4 weeks of oral supplementation with 200 ml per day of QGP juice with commercially available 200 ml/day for 4 weeks Bickford Prune juice and a 200ml/day for 4 weeks placebo in 20 normal healthy male and female participants between ages of 18 to 65 years. There will be two weeks washout period between each treatment. The blood and urine sample will be collected pre and post each supplementation period.

Arm 2:
After 2 weeks of no treatment ( washout period) the articipants will start second protocol of the trial.. In the second protocol of this same study all the participants from first protocol will be invited to continue after 2 weeks washout period, however incase there is any participant who does not want to continue, will be allowed to stop at that stage and the new participants will be recruited to replace those who withdraw to maintain total number of 20 normal healthy male and female volunteers for the second protocol. All the participants in this second protocol will be asked to repeat the same intervention as in first protocol that is 200ml/day over 4 weeks of QGP and Placebo treatment with a two weeks washout period between the two treatmemnts. However this time the participants will provide blood and urine sample both before and after 45-60 minutes of monitored acute exercise undertaken by cycling in laboratory at 70% of their maximal aerobic power (VO2max) at the start and finish of the supplementation. A doctor will determine the duration of exercise based on participants capability and fitness for each participant by conducting VO2max test on each volunteer before the supplementation for second protocol starts. Each participant will carry out the exercise 4 times over the complete trial period. Prior to first supplementation (baseline exercise will be undertaken on day 1 of protocol 2 immediately after the fasting blood and urine sample collection with second sample collected within 30 minutes of completing the exercise. Second bout of exercise will be conducted on day 29 of the second protocol with blood and urine sample collected before and after the exercise again. After 2 weeks washout period the third bout of exercise will be undertaken by participants on day 44 before starting second treatment and again the final and 4th bout of exercise regimen will be on day 72 that is 4 weeks after final supplementation period of second protocol.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Comparator / control treatment

The colour and consistency matched placebo will be 1:4 diluted commercial Raspberry Cordial (Coles brand) with minimal antioxidant capacity and energy levels compared to QGP and sugar levels consistent with the Bickford Prune and QGP juices.

Control group

Placebo

Outcomes

Primary outcome [1]

Full Blood Examination: EDTA whole blood analysis

Platelet activity: Platelet rich plasma to be tested by platelet aggregometry + Whole blood platelet surface markers for 2 different pathways to be tested by Flow cytometery.

Haemostatic function: Citrated plasma to be tested for coagulation screen (PT and APTT) + Fibrinogen and DDimer measurements

Inflammation marker: Serum C-Reactive Protein (CRP) and IL-6

Lipids profile: serum Cholesterol ( total, HDL, LDL and ratio) and Triglyceride

Total Blood Antioxidant levels and full polyphenol screen: Polyphenol (anthocyanins) extraction from EDTA plasma using HPLC + serum Uric Acid and Total Antioxidant capacity

Urinary antioxidant and full panel of polyphenols excreted: Polyphenol extraction using HPLC

Timepoint [1]

Baseline ( immediately upon randomisation) and after 4 weeks supplementation with treatment 1

Primary outcome [2]

Timepoint [2]

After 2 weeks washout period, pre (6 weeks from randomisation) and post 4 weeks supplementation (10 weeks from randomisation) with treatment 2

Primary outcome [3]

Timepoint [3]

After another 2 weeks washout period, pre (12 weeks from randomisation) and post 4 weeks supplementation (16 weeks from randomisation) with treatment 3

Secondary outcome [1]

Platelet activity, haemostatic function, inflammation markers and lipids profile both pre and post induced oxidative stress (exercise at 70% of maximal aerobic power (VO2max) before and after 4 weeks consumption of QGP or placebo).
Similar testing protocol as used for primary outcomes with addition of citrate plasma tissue plasmin activator (tPA) and Plasmin activation inhibitor (PAI) by elisa and additional leukocyte (WBC) surface markers and tissue factor and factorX markers for haemostatic function by flowcytometry.

Timepoint [1]

Baseline (immediately upon randomisation after completion of 1st protocol in 16 weeks), post treatment after 4 weeks supplementation with treatment 1 of protocol 2 ( at 20 weeks).
After 2 weeks washout period, pre supplementation sample collection at 22 weeks followed by final blood and urine collection post 4 weeks supplementation with treatment 2 (at 26 weeks) .

Eligibility

Key inclusion criteria

Normal healthy non smokers with no history of heart disease or bleeding disorder. Volunteers not on any special diet or medication. Health and food frequency questionnaire and baseline Full Blood Examination (all parameters must be within normal healthy population reference range) will be examined to confirm health status.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Excessive bleeding tendency
History of problem with venepuncture
Anti-Coagulant therapy
Recent GI bleed
History of Heart and Liver Disease
Anti-inflammatory Drugs affecting platelets ( in particular aspirin)
Regular Multivitamin intake
Plt <125 & >450

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Computerised Excel derived randomisation followed by proper concealment.
Beverage containers packed by a scientist off site and labelled with only “A”, “B” and “C”.
Researchers conducting the trail and testing at our university do not know what beverage has been provided to which participants at what time period. The list of treatment allocation is kept off site by the scientists involved in diluting and packaging the beverages.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation was used to create randomised table by computer software (computerised sequence generation).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

10/06/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

4215

Recruitment postcode(s) [2]

4214

Recruitment postcode(s) [3]

4216

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith University

Address [1]

School Of Medical Science
Health Building #5
Parklands Drive
Gold Coast Campus
Griffith University, QLD, 4215

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF)

Address [2]

39 Kessels Road, Coopers Plains QLD 4108

Country [2]

Australia

Primary sponsor type

University

Name

Griffith University

Address

School Of Medical Science
Health Building #5
Parklands Drive
Gold Coast Campus
Griffith University, QLD, 4215

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Office for Research
Nathan campus
Room 0.10D, Bray Centre (N54)
Griffith University
170 Kessels Road QLD 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/05/2012

Ethics approval number [1]

MSC/02/12/HREC

Summary

Brief summary

Queen Garnet Plum (QGP) is a result of a Queensland Government innovative breeding project. Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF) has shown QGP to have 5-10 times higher antioxidant levels compared to all other varieties of plums.

We hypothesize that antioxidant rich QGP may lead to decreased platelet and clotting activity, reducing inflammation and improving lipid profile by influencing fat metabolism in normal healthy population as well as under increased oxidative stress conditions.

The aims of the present double blind crossover interventional study are to compare and examine effectiveness of the 4 weeks supplementation of Queen Garnet Plum with commercial Bickford prune juice and a colour and sugar matched placebo on platelet and haemostatic function as well as inflammation markers and lipid profile in normal healthy population. We wish to prove our hypothesis that due to high antioxidant (anthocyanin) content these fruits may be instrumental in preventing cardiovascular disorders by attenuating platelet and haemostatic activity.

For the first protocol of the study, 20 volunteers will be screened for recruitment to the study based on inclusion and exclusion criteria. Each participant will undertake 3 oral supplementation treatments for 4 weeks each with a washout period of two weeks between each treatment. A pre and post treatment fasting blood and urine sample will be collected to evaluate the efficacy of each treatment and comparison between placebo and two types of plums. Each blood sample will be tested for full blood examination, 3 different types of platelet function tests, coagulation profile, inflammation marker, lipid profile, uric acid and full blood + urine antioxidant levels with specific polyphenol quantitative screen.

Second protocol will be similar to first protocol but with only 2 oral supplementation treatments of 4 weeks each with one 2 week washout period between them. The participants will be tested for VO2max by physician trained in exercise science prior to starting this protocol of the trial. A fasting blood and urine sample will be collected from each participant both pre and post induced oxidative stress by 45 min – 60 min exercise at 70% of maximal aerobic power (VO2max) before and after 4 weeks consumption of QGP and placebo. Testing protocol will be similar but including some specialised testing of platelet surface markers and thrombolytic pathways to examine the mechanistic pathways affected by the plum supplementation in reducing the thrombotic risk factors.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Indu Singh

Address

School Of Medical Science
G05_2.33
Parklands Drive
Gold Coast Campus
Griffith University, QLD, 4215

Country

Australia

Phone

+61 7 55529821

Fax

+61 7 55528908

[email protected]

Contact person for scientific queries

Name

Indu Singh

Address

School Of Medical Science
G05_2.33
Parklands Drive
Gold Coast Campus
Griffith University, QLD, 4215

Country

Australia

Phone

+61 7 55529821

Fax

+61 7 55528908

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Consumption of anthocyanin-rich Queen Garnet plum juice reduces platelet activation related thrombogenesis in healthy volunteers	2015	https://doi.org/10.1016/j.jff.2014.10.026

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically