ANZCTR - Registration

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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]

NIL

Universal Trial Number (UTN)

U1111-1168-1949

Trial acronym

Linked study record

Health condition

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

Diabetes

Obesity

Cardiovascular

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

Diabetes

Diet and Nutrition

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]

Prevention

Intervention code [2]

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]

Platelet activity and haemostatic function

Timepoint [1]

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]

Inflammation markers

Timepoint [2]

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]

Lipid profile

Timepoint [3]

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]

Adiponectin

Timepoint [1]

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]

Leptin

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

6/04/2015

Actual

Date of last participant enrolment

Anticipated

20/04/2015

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Griffith Health Institute and Gold Coast University Hospital (GHIGCUH) Collaborative Grant

Address [1]

1 Parklands Drive
Southport
Queensland 4215

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

1 Parklands Drive
Southport 4215
Queensland

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Gold Coast University Hospital

Address [1]

1 Hospital Boulevard
Southport 4215
Queensland

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

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

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/06/2014

Approval date [1]

01/08/2014

Ethics approval number [1]

MSC/07/14/HREC

Ethics committee name [2]

Queensland Health (Gold Coast Hospital and Health Services) HREC

Ethics committee address [2]

Gold Coast University Hospital
Level 5
D Block, Room 101
Hospital Boulevard
SOUTHPORT QLD 4215

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

06/10/2014

Approval date [2]

28/11/2014

Ethics approval number [2]

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

Attachments [1]

/AnzctrAttachments/368161-Diabetes project proposal.pdf

Contacts

Principal investigator

Name

Dr Indu Singh

Address

Griffith University
G05_2.33,
Gold Coast Campus
Parklands Drive
Southport 4215
Queensland

Country

Australia

Phone

+61755529821

Fax

+61 7 55528908

i.singh@griffith.edu.au

Contact person for public queries

Name

Indu Singh

Address

Griffith University
G05_2.33,
Gold Coast Campus
Parklands Drive
Southport 4215
Queensland

Country

Australia

Phone

+61755529821

Fax

+61 7 55528908

i.singh@griffith.edu.au

Contact person for scientific queries

Name

Indu Singh

Address

Griffith University
G05_2.33,
Gold Coast Campus
Parklands Drive
Southport 4215
Queensland

Country

Australia

Phone

+61755529821

Fax

+61 7 55528908

i.singh@griffith.edu.au

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	Anthocyanin supplementation inhibits secretion of pro-inflammatory cytokines in overweight and obese individuals	2020	https://doi.org/10.1016/j.jff.2019.103596
Embase	Potential of anthocyanin as an anti-inflammatory agent: a human clinical trial on type 2 diabetic, diabetic at-risk and healthy adults.	2021	https://dx.doi.org/10.1007/s00011-021-01438-1

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

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Documents added manually

Documents added automatically