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

NCT03742492 — Phase 2, Unknown, 28 participants, Universidade do Porto

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

RegistryNCT03742492
StatusUnknown
PhasePhase 2
Study typeInterventional; randomized, crossover, masking: quadruple, basic science
Enrollment28 (Estimated)
SponsorUniversidade do Porto (Other); collaborators: Center for Health Technology and Services Research, NOVA Medical School
ConditionsHealthy Volunteers
InterventionsMeal containing canned tuna + fish oil (5 g EPA + DHA), Meal containing canned tuna + soybean oil (Dietary supplement)
Datesstart 2018-09-19, primary completion 2019-06-01 (estimated), completion 2019-07-01 (estimated), first posted 2018-11-15, last updated 2019-05-30
Locations1 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

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Canned tuna + fish oil (5 g EPA + DHA)ExperimentalDietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA)Meal containing canned tuna + fish oil (5 g EPA + DHA)
Canned tuna + soybean oilPlacebo comparatorDietary Supplement: Meal containing canned tuna + soybean oilMeal containing canned tuna + soybean oil
  • 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 oil (Dietary supplement): Meal containing canned tuna + soybean oil

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
CINTESIS - Faculty of Medicine of the University of PortoPortoPortugal

+Investigators

  • Conceição Calhau, PhD, Principal investigator, CINTESIS, NOVA Medical School
  • Luís Azevedo, PhD, Principal investigator, CINTESIS, Faculty of Medicine of the University of Porto