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Trial registered on ANZCTR


Registration number
ACTRN12615000293561
Ethics application status
Approved
Date submitted
11/03/2015
Date registered
27/03/2015
Date last updated
27/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Antioxidants as cardioprotective therapy in aspirin resistant diabetes
Scientific title
Effect of anthocyanin antioxidants on platelet function and activity, lipid profile and inflammation in four different groups: healthy participants, those with diabetes with and without a history of cardiovascular disease, and those with pre-diabetes.
Secondary ID [1] 286342 0
NIL
Universal Trial Number (UTN)
U1111-1168-1949
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 294459 0
Obesity 294460 0
Cardiovascular 294521 0
Condition category
Condition code
Cardiovascular 294769 294769 0 0
Coronary heart disease
Metabolic and Endocrine 294827 294827 0 0
Diabetes
Diet and Nutrition 294828 294828 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
Anthocyanin capsules from Bilberrie and Black Currants containing 80 mg anthocyanin citrates per capsule ( daily consumption 4 capsules = 320 mg anthocyanin per day for 4 weeks).
Arm 2:
Aspirin 81 mg per tablet (1 tablet daily for 4 weeks)
There will be 4 weeks of washout period between 2 crossover arms. Each participants will receive both arms of the treatment with random allocation to (generated by computer) either arm 1 as first treatment or arm 2 as first treatment with a cross over after 4 weeks washout period.
Compliance will be monitored by followup phone calls a week after starting the intervention and again a week before returning back for post treatment blood collection. Each participant will be provided with a few extra tablets (different numbers) and they will be asked to return left over tablets. The count of returned tablet will check for compliance.
Intervention code [1] 291398 0
Prevention
Intervention code [2] 291400 0
Treatment: Drugs
Comparator / control treatment
The controls are the baseline for each participant. The treatment of participants with diabetes and pre diabetes will be compared with normal healthy participants results difference between pre and post each treatment.
Control group
Active

Outcomes
Primary outcome [1] 294522 0
Platelet activity and haemostatic function
Timepoint [1] 294522 0
Whole blood flow cytometry for activated platelet surface markers, citrate plasma for platelet aggregation and coagulation assays at baseline (immediately upon randomization) and after 4 weeks supplementation with first treatment and again pre and post second treatment.
Primary outcome [2] 294523 0
Inflammation markers
Timepoint [2] 294523 0
Serum hs-CRP, IL6 and MCP-1 for inflammation at baseline (immediately upon randomization) and after 4 weeks supplementation with first treatment and again pre and post second treatment.
Primary outcome [3] 294617 0
Lipid profile
Timepoint [3] 294617 0
Lipid profile including total cholesterol, triacylglycerol, HDL and LDL Cholesterol assays at baseline (immediately upon randomization) and after 4 weeks supplementation with first treatment and again pre and post second treatment.
Secondary outcome [1] 313563 0
Adiponectin
Timepoint [1] 313563 0
Serum adiponectin assay by Elisa method at baseline (immediately upon randomization), 4 weeks post supplementation with treatment 1
After 4 weeks washout period, pre (8 weeks from randomization) and post 4 weeks supplementation (12 weeks from randomization) with treatment 2.
Secondary outcome [2] 313679 0
Leptin
Timepoint [2] 313679 0
Serum leptin assay by Elisa method at baseline (immediately upon randomization), 4 weeks post supplementation with treatment 1
After 4 weeks washout period, pre (8 weeks from randomization) and post 4 weeks supplementation (12 weeks from randomization) with treatment 2.

Eligibility
Key inclusion criteria
Group 1:
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 within normal healthy population reference range) will be examined by a doctor (one of the investigators in our research team) to confirm health status.
Group 2:
Patient with diabetes but no history of heart disease, non smoker and with no other bleeding disorder or thrombosis and not on any other medication except diabetes treatment.
Group 3:
Patient with diabetes and previous history of heart disease, non smoker and with no other bleeding disorder or thrombosis and not on any other medication except diabetes treatment.
Group 4:
Pre-diabetes (sedentary people with BMI greater thnn 30 and atleast 2 other risk factors increasing chance of acquiring diabetes, non smoker and with no other bleeding disorder or thrombosis and not on any other medication except diabetes treatment.
Minimum age
25 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Excessive bleeding tendency
2. Anti-Coagulant therapy
3. Recent GI bleed
4. Liver Disease
5. Anti-inflammatory Drugs affecting platelets
6. Platelet count of <125 & >450 X 1000 million/L of blood

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)
Computerised Excel derived randomisation followed by proper concealment.
Tablet containers packed by a scientist off site and labelled with only “A” and “B”
Researchers conducting the trail and testing in our research laboratory do not know which tablets have been provided to which participants at what time period. The list of treatment allocation is kept off site by the scientists who performed randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization was used to create randomized table by computer software (computerized sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
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)
QLD

Funding & Sponsors
Funding source category [1] 290917 0
Other Collaborative groups
Name [1] 290917 0
Griffith Health Institute and Gold Coast University Hospital (GHIGCUH) Collaborative Grant
Address [1] 290917 0
1 Parklands Drive
Southport
Queensland 4215
Country [1] 290917 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
1 Parklands Drive
Southport 4215
Queensland
Country
Australia
Secondary sponsor category [1] 289600 0
Hospital
Name [1] 289600 0
Gold Coast University Hospital
Address [1] 289600 0
1 Hospital Boulevard
Southport 4215
Queensland
Country [1] 289600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292520 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 292520 0
Griffith University
Office for Research
Room 0.10 D, Bray Centre (N54)
170 Kessels Road
NATHAN QLD 4111
Ethics committee country [1] 292520 0
Australia
Date submitted for ethics approval [1] 292520 0
30/06/2014
Approval date [1] 292520 0
01/08/2014
Ethics approval number [1] 292520 0
MSC/07/14/HREC
Ethics committee name [2] 292521 0
Queensland Health (Gold Coast Hospital and Health Services) HREC
Ethics committee address [2] 292521 0
Gold Coast University Hospital
Level 5
D Block, Room 101
Hospital Boulevard
SOUTHPORT QLD 4215
Ethics committee country [2] 292521 0
Australia
Date submitted for ethics approval [2] 292521 0
06/10/2014
Approval date [2] 292521 0
28/11/2014
Ethics approval number [2] 292521 0
HREC/14/QGC/181

Summary
Brief summary
Diabetes results in an increase in the stickiness of platelets, which may result in blockage of arteries and other cardiovascular diseases. This is usually prevented with conventional cardiovascular medication (most commonly used Aspirin).
Aspirin is a commonly used antiplatelet therapy (blood thinner) for patients with cardiovascular disease. However, it has greatly reduced efficacy in diabetes.
This project is being conducted to evaluate an alternative to aspirin such as anthocyanin which is an antioxidant that has been shown to reduce narrowing of arteries.
This study will compare the protective effects of aspirin with anthocyanin supplement, which is a rich natural antioxidant, on platelet (blood cells involved in clotting of blood and when not functioning normally can lead to risk of cardiovascular diseases such as stroke, heart attack or other heart diseases) function and activity as well as lipid (cholesterol and other fats) profile and inflammation. Any decrease in platelet activity and improvement in lipid profile and inflammation following the treatment will be suggestive of decreased thrombotic (narrowing and blocking of arteries responsible for heart attack and strokes) tendency and risk of heart disease in patients with diabetes.
One hundred participants from 4 groups (normal healthy, diabetes with history of cardiovascular diasese, diabetes without cardiovascular disease and pre-diabetes populations) will consume either aspirin tablets 81 mg/day (1 tablet daily) or 320mg (4 tablets daily) anthocyanins (antioxidants from billberries and blackcurrant) for four weeks each as first treatment. they will then take second treatment after 4 weeks washout period. The fasting blood and urine sample will be collected at the baseline and post first treatment and again pre and post second treatment.
Each blood sample will be tested for full blood examination, 3 different types of platelet function tests, coagulation profile, inflammation marker, HbA1c, lipid profile, uric acid and full blood + urine antioxidant levels and microalbumin.
The data from this study will be used to guide management of antiplatelet and anticoagulant therapy more effectively in this population.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55702 0
Dr Indu Singh
Address 55702 0
Griffith University
G05_2.33,
Gold Coast Campus
Parklands Drive
Southport 4215
Queensland
Country 55702 0
Australia
Phone 55702 0
+61755529821
Fax 55702 0
+61 7 55528908
Email 55702 0
i.singh@griffith.edu.au
Contact person for public queries
Name 55703 0
Dr Indu Singh
Address 55703 0
Griffith University
G05_2.33,
Gold Coast Campus
Parklands Drive
Southport 4215
Queensland
Country 55703 0
Australia
Phone 55703 0
+61755529821
Fax 55703 0
+61 7 55528908
Email 55703 0
i.singh@griffith.edu.au
Contact person for scientific queries
Name 55704 0
Dr Indu Singh
Address 55704 0
Griffith University
G05_2.33,
Gold Coast Campus
Parklands Drive
Southport 4215
Queensland
Country 55704 0
Australia
Phone 55704 0
+61755529821
Fax 55704 0
+61 7 55528908
Email 55704 0
i.singh@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results