Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects

Universidade do Porto

Status and phase

Unknown

Phase 2

Conditions

Healthy Volunteers

Treatments

Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA)

Dietary Supplement: Meal containing canned tuna + soybean oil

Study type

Interventional

Funder types

Other

Identifiers

NCT03742492

FUNCTIONALTUNA1

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

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