None listed
Conditions
Brief summary
The FOCUS IN study is a clinical trial evaluating the impact of omega-3 fatty acids, found in fish oil, on inflammatory factors that contribute to heart disease. Coronary heart disease is due to a process called atherosclerosis, which the build-up of fatty tissue and plaque in arteries. Inflammation has been shown to be an important causal factor in atherosclerosis, and omega-3 fatty acids have been shown to have anti-inflammatory properties in previous studies. Study participants will be randomised to supplementation with various types of fish oil or a placebo for 30 days, and serum will be taken before and after supplementation. Serum will be added to cells in culture, derived from blood vessels and fat cells, and the impact of the serum on inflammatory factors that contribute to heart disease will be measured. This method of adding omega-3s to cells is a more biologically plausible method of studying the impact of omega-3 consumption on cellular function than adding pure omega-3s directly. The results of this study will guide further human studies of omega-3 supplementation on the development of heart disease.
Interventions
Healthy human volunteers will be randomised to one of four groups:
Group 1: Fish oil capsules high in EPA.
Group 2: Fish oil capsules high in DHA.
Group 3: Standard fish oil capsules, with 3:2 ratio of EPA to DHA.
Group 4: Placebo capsules.
Participants will be randomised in a 1:1:1:1 ratio. Participants will have blood taken before supplementation, and again after 30 days of supplementation.
Group 1: 8 capsules per day for 30 days. Each capsules contains 500mg of EPA and negligible DHA. A
Healthy human volunteers will be randomised to one of four groups: Group 1: Fish oil capsules high in EPA. Group 2: Fish oil capsules high in DHA. Group 3: Standard fish oil capsules, with 3:2 ratio of EPA to DHA. Group 4: Placebo capsules. Participants will be randomised in a 1:1:1:1 ratio. Participants will have blood taken before supplementation, and again after 30 days of supplementation. Group 1: 8 capsules per day for 30 days. Each capsules contains 500mg of EPA and negligible DHA. Adherence monitored by counting of returned capsules. Group 2: 6 capsules per day for 30 days. Each capsules contains 30mg of EPA and 707.5mg of DHA. Adherence monitored by counting of returned capsules. Group 3: 7 capsules per day for 30 days. Each capsules contains 400mg of EPA and 200mg of DHA. Adherence monitored by counting of returned capsules. Group 4: 7 capsules per day for 30 days. Each capsules contains 10mg of EPA and 6mg DHA. Adherence monitored by counting of returned capsules.
Sponsors
Dr Anthony Pisaniello
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy adult male and female human volunteers with no significant past medical history.
Exclusion criteria
Current cardiovascular medications. Regular use of anti-inflammatory medications or blood-thinning medications. Current regular fish oil consumption or regular consumption within the last 6 months. Regular consumption of 2 or more fish meals per week over the last 6 months. Pregnant and breastfeeding women are excluded. Language barrier. Seafood allergy and intolerance to fish oil capsules. Anticipated medical indication for interruption of fish oil consumption during study.
Outcome results
None listed