Trials / Completed
CompletedNCT03603769
In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University of Limerick · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim of this project is to study the effects of a new-developed food-supplement that contains bioactive polar lipids derived from organic farmed Irish salmon for the beneficial promotion of cardiovascular health. The health claims that will be formulated for this nutraceutical are based on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects at very low risk of CV disease normally have non-activated circulating platelets. Decreasing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g. four weeks) would be a beneficial physiological effect". Within this study, the postprandial effects of this novel food supplement against platelet aggregation and inflammation are going to be exploited ex vivo in blood from human subjects as described in previously established procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Food supplement capsules containing Salmon-Polar Lipids | Postprandial decreased Platelet activation/aggregation in subjects, after the food supplement capsule consumption |
| DIETARY_SUPPLEMENT | Placebo food supplement capsule | Postprandial unaffected platelet activation/aggregation in subjects, after the food supplement capsule consumption |
Timeline
- Start date
- 2018-09-03
- Primary completion
- 2018-11-30
- Completion
- 2019-01-31
- First posted
- 2018-07-27
- Last updated
- 2019-12-19
Locations
1 site across 1 country: Ireland
Source: ClinicalTrials.gov record NCT03603769. Inclusion in this directory is not an endorsement.