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Healthy VolunteersPhase 2NCT03742492

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

A Phase 2 study testing Meal containing canned tuna + fish oil (5 g EPA + DHA) and Meal containing canned tuna + soybean oil in people with Healthy Volunteers, run by Universidade do Porto at 1 site in Portugal.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Meal containing canned tuna + fish oil (5 g EPA + DHA) and Meal containing canned tuna + soybean oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
1 sitePortugal
Study dates
19 Sep 2018to Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • CINTESIS - Faculty of Medicine of the University of Porto

    Porto, 4200-450

Other trials in Portugal

About this study

Official title: Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects on Cardiovascular Risk Markers, in Healthy Human Volunteers

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.

Being tested
Meal containing canned tuna + fish oil (5 g EPA + DHA), Meal containing canned tuna + soybean oil
Keywords
Omega-3 fatty acids, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), Bioavailability, Blood pressure, Lipid absorption, Canned tuna

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Meal containing canned tuna + soybean oilDietary supplement

    Meal containing canned tuna + soybean oil

Study groups in NCT03742492
Study groupRoleWhat they receive
Canned tuna + fish oil (5 g EPA + DHA)ExperimentalMeal containing canned tuna + fish oil (5 g EPA + DHA)
Receives: Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA)
Canned tuna + soybean oilPlacebo comparatorMeal containing canned tuna + soybean oil
Receives: Dietary Supplement: Meal containing canned tuna + soybean oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in postprandial plasma triglycerides concentrations

    Impact on the postprandial levels of triglycerides (0, 1, 2, 3, 4, and 5 hours post-meal).

    Measured: Up to 5 hours post-meal.

  2. 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).

    Measured: Up to 5 hours post-meal.

  3. 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).

    Measured: Up to 5 hours post-meal.

Secondary outcomes (7)

  1. Change in postprandial blood pressure

    Impact on the postprandial levels of blood pressure (0, 1, 2, 3, 4, and 5 hours post-meal).

    Measured: Up to 5 hours post-meal.

  2. 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).

    Measured: Up to 5 hours post-meal.

  3. Change in postprandial plasma eicosapentaenoic acid (EPA) concentrations

    Impact on the postprandial levels of EPA (0, 2, 4, and 5 hours post-meal).

    Measured: Up to 5 hours post-meal.

  4. Change in postprandial plasma docosahexaenoic acid (DHA) concentrations

    Impact on the postprandial levels of DHA (0, 2, 4, and 5 hours post-meal).

    Measured: Up to 5 hours post-meal.

  5. 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).

    Measured: Up to 5 hours post-meal.

  6. Change in postprandial plasma insulin concentrations

    Impact on the postprandial levels of insulin (0, 1, 2, 3, 4, and 5 hours post-meal).

    Measured: Up to 5 hour post-meal.

  7. 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).

    Measured: Up to 5 hours post-meal.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start19 Sep 2018
  3. Primary completionJun 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742492
Sponsor's protocol ID
FUNCTIONALTUNA1
Status last verified
Apr 2019
First submitted
6 Nov 2018
Last updated
30 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Meal containing canned tuna + fish oil (5 g EPA + DHA) and Meal containing canned tuna + soybean oil in people with Healthy Volunteers, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in postprandial plasma triglycerides concentrations (time frame: Up to 5 hours post-meal.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03742492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.

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