None listed
Conditions
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.
Interventions
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 a
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.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 75 Years
Healthy volunteers
No
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.
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
Outcome results
None listed