Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects (NCT03742492) | Clinical Trial Compass
UnknownPhase 2
Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects
Portugal28 participantsStarted 2018-09-19
Plain-language summary
Evidence has suggested that omega-3 fatty acids, namely eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have an important role in promoting cardiovascular health. However, the currently available scientific literature describing the postprandial effects and bioavailability of these fatty acids, particularly when they are incorporated into high protein food item, like canned tuna, is far from conclusive.
The aim of this study is to evaluate the acute bioavailability of EPA + DHA enriched canned tuna and its acute effects on cardiovascular risk markers, in healthy human volunteers.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult men or women
* Age 18 - 59 years
* Willing to maintain usual diet and physical activity patterns
* Willing to comply with study protocol and procedures
* Willing to provide written informed consent
Exclusion Criteria:
* Pregnant, breastfeeding or planning to become pregnant within the study period
* Subjects with current or previous cardiovascular disease (ischemic cardiovascular disease, angina stable or unstable; myocardial infarction, stroke or symptomatic peripheral arteriosclerosis)
* Subjects with liver or kidney diseases or cancer
* Diabetes mellitus (fasting glycemia\> 126 mg / dL)
* Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to cooperate during the study
* Subjetcs with gastrointestinal disorder or under prescription for medication affecting gastrointestinal function or absorption of nutrients
* Known allergy (or sensitivity) to omega-3 fatty acids, fish (tuna), crustaceans, lactose or any meal ingredient
* With antihypertensive therapy
* Health condition that prevents compliance with study requirements
* Subjects under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
* Subjects under prescription of anticoagulant drugs
* Dietary patterns or supplement use that could interfere with st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in postprandial plasma triglycerides concentrations
Timeframe: Up to 5 hours post-meal.
2
Change in postprandial plasma low-density lipoprotein (LDL) cholesterol concentrations
Timeframe: Up to 5 hours post-meal.
3
Change in postprandial plasma total cholesterol concentrations