Status unknownNCT03742492Updated May 30, 2019

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

A Phase 2 interventional study of Meal containing canned tuna + fish oil (5 g EPA + DHA) and Meal containing canned tuna + soybean oil in Healthy Volunteers, sponsored by Universidade do Porto. Status unknown at 1 site in Portugal. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Universidade do Porto · Phase 2, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 18 Years to 59 Years
Sex: All

Study 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 studied

Healthy Volunteers

Keywords

Omega-3 fatty acids
Eicosapentaenoic acid (EPA)
Docosahexaenoic acid (DHA)
Bioavailability
Blood pressure
Lipid absorption
Canned tuna

In context

Lead sponsor

Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 59 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 28 participants (estimated)

Study arms

Experimental
Canned tuna + fish oil (5 g EPA + DHA)
Meal containing canned tuna + fish oil (5 g EPA + DHA)
Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA)
Placebo comparator
Canned tuna + soybean oil
Meal containing canned tuna + soybean oil
Dietary Supplement: Meal containing canned tuna + soybean oil

Interventions

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

What researchers measure

Primary outcomes

Change in postprandial plasma triglycerides concentrations
Impact on the postprandial levels of triglycerides (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.
Change in postprandial plasma low-density lipoprotein (LDL) cholesterol concentrations
Impact on the postprandial levels of LDL cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.
Change in postprandial plasma total cholesterol concentrations
Impact on the postprandial levels of total cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.

Secondary outcomes

Change in postprandial blood pressure
Impact on the postprandial levels of blood pressure (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.
Change in postprandial plasma high-density lipoprotein (HDL) cholesterol concentrations
Impact on the postprandial levels of HDL cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.
Change in postprandial plasma eicosapentaenoic acid (EPA) concentrations
Impact on the postprandial levels of EPA (0, 2, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.
Change in postprandial plasma docosahexaenoic acid (DHA) concentrations
Impact on the postprandial levels of DHA (0, 2, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.
Change in postprandial plasma blood glucose concentrations
Impact on the postprandial levels of blood glucose (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.
Change in postprandial plasma insulin concentrations
Impact on the postprandial levels of insulin (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hour post-meal.
Change in postprandial plasma Apolipoprotein B-48 (apoB-48) concentrations
Impact on the postprandial levels of ApoB-48 (0, 1, 2, 3, 4, and 5 hours post-meal).
Time frame: Up to 5 hours post-meal.

Study locations

1 site

CINTESIS - Faculty of Medicine of the University of Porto
Porto, 4200-450, Portugal

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03742492
Lead sponsor: Universidade do Porto
Collaborators: Center for Health Technology and Services Research, NOVA Medical School
Responsible party: Sponsor
First posted: Nov 15, 2018
Start date: Sep 19, 2018
Primary completion: Jun 2019 (estimated)
Completion: Jul 2019 (estimated)
Last update: May 30, 2019

Study contacts

Conceição Calhau, PhD

principal investigator · CINTESIS, NOVA Medical School

Luís Azevedo, PhD

principal investigator · CINTESIS, Faculty of Medicine of the University of Porto

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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