None listed
Conditions
Brief summary
Coronary artery disease (CAD) accounts for 50% of all heart disease cases and 9.2% of all deaths in Australia. Supplementation with omega-3 fatty acids from fish oil shows promise for reducing adverse cardiovascular events. However, current guidelines for omega-3 supplementation vary in their recommended doses, and the optimal dose for better cardiovascular outcomes remains unclear in the literature. In this study, participants will undergo a 12-week period of individualised dose of supplementation with either a placebo or omega-3 fatty acids (fish oil) to determine whether this strategy improves vascular health. Outcome measures will be assessed at baseline, mid-intervention and after completion of the interventions.
Interventions
Usual care and standard nutritional advice:
All participants will receive usual care and medical guidance, along with all necessary medications and procedures from their local doctors and cardiologists throughout the study. Moreover, participants in both groups will receive standard nutritional advice in the form of an informational brochure. The standard nutritional advice follows the heart-healthy eating pattern recommended by the National Heart Foundation of Australia. This standard nutritio
Usual care and standard nutritional advice: All participants will receive usual care and medical guidance, along with all necessary medications and procedures from their local doctors and cardiologists throughout the study. Moreover, participants in both groups will receive standard nutritional advice in the form of an informational brochure. The standard nutritional advice follows the heart-healthy eating pattern recommended by the National Heart Foundation of Australia. This standard nutritional advice includes 250-500 mg/day of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) as the long-chain omega-3 polyunsaturated fatty acids (n-3 PUFA). This amount of n-3 PUFAs can be obtained from 2–3 servings (200-300 g) of oily fish per week as part of a regular diet. This dietary pattern consists of five principal guidelines: (1) daily consumption of plenty of vegetables and fruits; (2) choosing a variety of healthy protein sources, especially fish and seafood (240 grams per week) and legumes; (3) daily consumption of unflavoured milk, yogurt, and cheese; (4) choosing healthy fats and oils, such as nuts, seeds, avocados, olives, and their oils; (5) using herbs and spices for flavouring daily food instead of table salt. Adherence to the heart-healthy eating pattern will be assessed using the checklist provided at the end of the informational brochure at baseline and at the final outcome assessment visit. Individualised n-3 PUFA supplementation: Participants in the experimental group will receive individualised supplementation of concentrated fish n-3 PUFAs containing 72% EPA and 28% DHA in the form of triglyceride soft gel capsules (UltraClean® 85, BioCeuticals™, Blackmores, Australia). Each capsule weighs 1 g, containing 562 mg of EPA plus 215 mg of DHA (total of 777 mg n-3 PUFAs). The dosage will be individualised for each participant based on their baseline Omega-3 Index, with the aim of achieving an Omega-3 Index of = 8% during a 12-week intervention. The omega-3 PUFA dose will be 777 mg/day (1 capsule), 1,550 mg/day (2 capsules), and 2,330 mg/day (3 capsules) for participants with an Omega-3 Index of >5.5%, 4.5-5.5%, and <4.5%, respectively. Adherence and compliance: The protocol employs three strategies to monitor and promote adherence to both the placebo and omega-3 fatty acids supplementation interventions. First, to ensure participants follow the supplementation protocol, their total three-month supply will be checked during the mid-intervention visit. Second, participants will be asked to complete a daily adherence diary to record any days they miss taking their supplements. To further support compliance, the third strategy involves phone call reminders once a week to participants. Additionally, at the end of the study, participants will be asked to return any unused or remaining capsules from the three-month period. Counting the returned capsules will give an objective measure of adherence, helping the research team assess how consistently participants followed the protocol.
Sponsors
University of the Sunshine Coast
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for the study if they meet all of the following criteria: 1. they are over the age of 18 years; 2. have a documented diagnosis of atherosclerotic coronary artery disease; and 3. have an Omega-3 Index of less than 8%.
Exclusion criteria
Participants will be excluded from the study if they meet any of the following criteria: 1. they have a known coagulopathy associated with impaired clot formation or excessive bleeding; 2. currently taking warfarin; 3. currently taking omega-3 fatty acid supplements, including any dose of the supplement within the last 12 weeks; 4. identify as following a vegan diet or have a known allergy or sensitivity to omega-3 fatty acids or seafood; 5. not being on a stable treatment regimen for at least 4 weeks, including the initiation or modification of medication or surgical procedures; 6. currently undergoing treatment for malignancies (e.g., chemotherapy or radiotherapy); 7. their GP or family doctor deems the intervention unsuitable for the participant (i.e., due to medical reasons); or 8. have been diagnosed with a terminal illness or have a severe medical condition, including organ failure, that may affect their ability to participate or complete the trial.
Outcome results
None listed