Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects on Cardiovascular Risk Markers, in Healthy Human Volunteers
| Registry | NCT03742492 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, crossover, masking: quadruple, basic science |
| Enrollment | 28 (Estimated) |
| Sponsor | Universidade do Porto (Other); collaborators: Center for Health Technology and Services Research, NOVA Medical School |
| Conditions | Healthy Volunteers |
| Interventions | Meal containing canned tuna + fish oil (5 g EPA + DHA), Meal containing canned tuna + soybean oil (Dietary supplement) |
| Dates | start 2018-09-19, primary completion 2019-06-01 (estimated), completion 2019-07-01 (estimated), first posted 2018-11-15, last updated 2019-05-30 |
| Locations | 1 site in Portugal |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials of Meal containing canned tuna + fish oil (5 g EPA + DHA) All trials of Meal containing canned tuna + soybean oil
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Canned tuna + fish oil (5 g EPA + DHA) | Experimental | Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA) | Meal containing canned tuna + fish oil (5 g EPA + DHA) |
| Canned tuna + soybean oil | Placebo comparator | Dietary Supplement: Meal containing canned tuna + soybean oil | Meal containing canned tuna + soybean oil |
Sex: All, ages: 18 Years to 59 Years, accepts healthy volunteers
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 study evaluations * Subjects not willing to avoid the consumption of fish oil or food supplements, including fatty acids, during the study (except as indicated in the study protocol) * Use of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
| Facility | City | Country | Status |
|---|---|---|---|
| CINTESIS - Faculty of Medicine of the University of Porto | Porto | Portugal |