Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000797572
Ethics application status
Approved
Date submitted
16/07/2015
Date registered
31/07/2015
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Potential of natural dietary antioxidants in improving heart health in obesity
Scientific title
Evaluating the potential of anthocyanin supplementation in reducing thrombogenesis in normal healthy and obese population
Secondary ID [1] 287103 0
Nil
Universal Trial Number (UTN)
Trial acronym
AORTA - Anthocyanins in Obesity Research Trial Australia
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 295625 0
Thrombosis 295626 0
Condition category
Condition code
Diet and Nutrition 295904 295904 0 0
Obesity
Alternative and Complementary Medicine 295905 295905 0 0
Other alternative and complementary medicine
Blood 295907 295907 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single Medox 80mg anthocyanin capsule contains: A purified extract from Bilberries and Black currants containing minimum 80 mg anthocyanincitrates; 110mg-170mg maltodextrin for stabilisation, Capsule - VCaps, HPMC, size 1, 7mmx20mm, 77 mg, neutral taste; Total weight of capsule: 390-410 mg. Dosage administered orally is: 320 mg/day (4 capsules - recommended dosage) for 28 days. Adherence to intervention will be measured by tablet return after 4 week supplementation. The wash out period is for two weeks before the start of supplementation with the next treatment (placebo) capsule for 28 days. The placebo capsule is a 265 mg maltodextrin capsule with a capsule weight of 80 mg: 345 mg total.The coloured maltodextrin consists of: Maltodextrin (87.5%), Wilton icing colour (red red 5%), Wilton icing colour (Royal blue 7.5%).
Intervention code [1] 292346 0
Prevention
Intervention code [2] 292347 0
Treatment: Drugs
Intervention code [3] 292395 0
Treatment: Other
Comparator / control treatment
Placebo capsule. The placebo capsule is a 265 mg maltodextrin capsule with a capsule weight of 80 mg: 345 mg total.The coloured maltodextrin consists of: Maltodextrin (87.5%), Wilton icing colour (red red 5%), Wilton icing colour (Royal blue 7.5%). The capsule itself is made of cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 295578 0
Platelet Activation measurement (Flowcytometry-BD FACS Verse). Blood sample will be used in testing
Timepoint [1] 295578 0
At baseline day 1 and post supplementation (treatment 1) day 29. Two week wash out. At baseline day 43 and post supplementation (treatment 2) day 72.
Primary outcome [2] 295640 0
Coagulation profile (Sysmex coagulation analyser). Blood sample (Plasma) will be used in testing
Timepoint [2] 295640 0
At baseline day 1 and post supplementation (treatment 1) day 29. Two week wash out. At baseline day 43 and post supplementation (treatment 2) day 72.
Primary outcome [3] 295641 0
Oxidative stress markers (Cobas Integra 400). Blood sample (plasma) will be used in testing
Timepoint [3] 295641 0
At baseline day 1 and post supplementation (treatment 1) day 29. Two week wash out. At baseline day 43 and post supplementation (treatment 2) day 72.
Secondary outcome [1] 315884 0
Food intake analysis using Xyris FoodWorks software. Food diaries completed by participants will be used in analysis.
Timepoint [1] 315884 0
After the end of the testing period i.e. on day 72 (One timepoint only)
Secondary outcome [2] 316059 0
Full Blood Count (AcT5 diff Beckman Coulter) (Primary outcome). Blood sample will be used in testing.
Timepoint [2] 316059 0
At baseline day 1 and post supplementation (treatment 1) day 29. Two week wash out. At baseline day 43 and post supplementation (treatment 2) day 72.
Secondary outcome [3] 316060 0
Biochemical profile (Cobas Integra 400) (Primary outcome). Blood sample (Serum) will be used in testing
Timepoint [3] 316060 0
At baseline day 1 and post supplementation (treatment 1) day 29. Two week wash out. At baseline day 43 and post supplementation (treatment 2) day 72.

Eligibility
Key inclusion criteria
BMI >30 for obese participants and 18-24.9 for healthy participants.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Excessive bleeding tendency, GI bleed or major surgery in last 6 wks
2. Liver Disease or coagulopathy
3. Anti-inflammatory, anti-platelet, anti-coagulation drugs
4. People on specific high antioxidant diet
5. Platelet count <100 & >450, Haematocrit<0.25

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be performed by an individual independent to the trial using a computer software. Unique identifier codes will be allocated to the participants. These codes will be used on sample containers and other labeling procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomization will be carried out using Microsoft Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using GraphPad Prism version 6.0 for Windows (GraphPad Software, La Jolla, CA, USA). A minimum sample size of 23 volunteers in each group (healthy and obese participants) is required for 80% power to detect a 5% variation in the laboratory parameters measured, where a 3–5% standard deviation exists in the population, assuming an alpha error of 0.05. Statistical significance will be established when P < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2015
Actual
11/09/2015
Date of last participant enrolment
Anticipated
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
15/05/2016
Sample size
Target
46
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9984 0
4702 - Central Queensland

Funding & Sponsors
Funding source category [1] 291661 0
University
Name [1] 291661 0
CQUniversity New staff grant
Country [1] 291661 0
Australia
Primary sponsor type
University
Name
CQUniversity
Address
CQUniversity, Bruce Highway
North Rockhampton
Queensland, Australia, 4702
Country
Australia
Secondary sponsor category [1] 290335 0
None
Name [1] 290335 0
Not applicable
Address [1] 290335 0
Not applicable
Country [1] 290335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293187 0
CQUniversity's Human Research Ethics Committee (EC00158)
Ethics committee address [1] 293187 0
Bruce Highway, North Rockhampton,
Queensland, Australia, 4702
Ethics committee country [1] 293187 0
Australia
Date submitted for ethics approval [1] 293187 0
14/07/2015
Approval date [1] 293187 0
28/08/2015
Ethics approval number [1] 293187 0

Summary
Brief summary
This project aims to evaluate the effect of anthocyanins, an antioxidant derived from fruits and vegetables, as an anti-thrombotic prophylaxis in normal healthy individuals versus obese pro-thrombotic individuals (predisposed to heart attacks and stroke). Increased platelet activity is an important contributor to thrombosis in vascular diseases. Antioxidants have been shown to act on several platelet activation pathways, reducing inflammatory responses thereby mimicking antiplatelet and anti-inflammatory drugs. We have previously shown that antioxidants in the form of a plum juice have potential to alleviate thrombotic risk in normal healthy population by reducing platelet aggregation, platelet activation and improving coagulation profile. Furthermore it has been demonstrated that anthocyanins target similar platelet activation pathways as aspirin (cyclooxygenase-1 pathway) and clopidogrel (ADP P2Y12 pathway), the commonly used antithrombotic drugs. In spite of the effectiveness of these drugs, prolonged usage has been associated with a number of side effects. We believe that anthocyanins have the potential to be used in the pro-thrombotic, drug resistant/non-responsive patient population either as a replacement or complementary therapy in prevention of cardiovascular diseases (CVD). The outcome of this project will significantly support a therapeutic alternative to currently used therapeutics, leading to effective prevention and treatment of oxidative stress induced metabolic syndrome conditions, providing fiscal and health benefit to society.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58842 0
Dr Abishek Santhakumar
Address 58842 0
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702.
Country 58842 0
Australia
Phone 58842 0
+61749309626
Fax 58842 0
Email 58842 0
[email protected]
Contact person for public queries
Name 58843 0
Dr Abishek Santhakumar
Address 58843 0
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702.
Country 58843 0
Australia
Phone 58843 0
+61749309626
Fax 58843 0
Email 58843 0
[email protected]
Contact person for scientific queries
Name 58844 0
Dr Abishek Santhakumar
Address 58844 0
CQUniversity, Bruce Highway
North Rockhampton, Queensland, Australia, 4702.
Country 58844 0
Australia
Phone 58844 0
+61749309626
Fax 58844 0
Email 58844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes K. Thompson, W. Pederick, I. Singh, A.B. Santhakum... [More Details]
Study results articleYes K. Thompson, H. Hosking, W. Pederick, I. Singh, A.... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of anthocyanin supplementation in modulating platelet function in sedentary population: A randomised, double-blind, placebo-controlled, cross-over trial.2017https://dx.doi.org/10.1017/S0007114517002124
N.B. These documents automatically identified may not have been verified by the study sponsor.