Potential of natural dietary antioxidants in improving heart health in obesity

Evaluating the potential of anthocyanin supplementation in reducing thrombogenesis in normal healthy and obese population

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000797572

Acronym

AORTA - Anthocyanins in Obesity Research Trial Australia

Enrollment

Registered

2015-07-31

Start date

2015-09-11

Completion date

2015-11-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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%).

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

BMI >30 for obese participants and 18-24.9 for healthy participants.

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

Outcome results