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

NCT ID: NCT03742492

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2019-07-31

Brief 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Canned tuna + fish oil (5 g EPA + DHA)

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Canned tuna + soybean oil

Meal containing canned tuna + soybean oil

Group Type: PLACEBO_COMPARATOR

Meal containing canned tuna + soybean oil

Intervention Type: DIETARY_SUPPLEMENT

Meal containing canned tuna + soybean oil

Interventions

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

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

Intervention Type: DIETARY_SUPPLEMENT

Meal containing canned tuna + soybean oil

Meal containing canned tuna + soybean oil

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Health Technology and Services Research

OTHER

Sponsor Role: collaborator

NOVA Medical School

OTHER

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Conceição Calhau, PhD

Role: PRINCIPAL_INVESTIGATOR

CINTESIS, NOVA Medical School

Luís Azevedo, PhD

Role: PRINCIPAL_INVESTIGATOR

CINTESIS, Faculty of Medicine of the University of Porto

Locations

CINTESIS - Faculty of Medicine of the University of Porto

Porto, , Portugal

Countries

Portugal

Other Identifiers

FUNCTIONALTUNA1

Identifier Type: -

Identifier Source: org_study_id