Clinical trial NCT03742492: Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects
Official title: Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects on Cardiovascular Risk Markers, in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Healthy Volunteers
Keywords: Omega-3 fatty acids
Eicosapentaenoic acid (EPA)
Docosahexaenoic acid (DHA)
Bioavailability
Blood pressure
Lipid absorption
Canned tuna
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
name: NOVA Medical School
First posted: 2018-11-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change in postprandial plasma triglycerides concentrations
timeFrame: Up to 5 hours post-meal.
measure: Change in postprandial plasma low-density lipoprotein (LDL) cholesterol concentrations
timeFrame: Up to 5 hours post-meal.
measure: Change in postprandial plasma total cholesterol concentrations
timeFrame: Up to 5 hours post-meal.
Secondary outcomes:
measure: Change in postprandial blood pressure
timeFrame: Up to 5 hours post-meal.
measure: Change in postprandial plasma high-density lipoprotein (HDL) cholesterol concentrations
timeFrame: Up to 5 hours post-meal.
measure: Change in postprandial plasma eicosapentaenoic acid (EPA) concentrations
timeFrame: Up to 5 hours post-meal.
measure: Change in postprandial plasma docosahexaenoic acid (DHA) concentrations
timeFrame: Up to 5 hours post-meal.
measure: Change in postprandial plasma blood glucose concentrations
timeFrame: Up to 5 hours post-meal.
measure: Change in postprandial plasma insulin concentrations
timeFrame: Up to 5 hour post-meal.
measure: Change in postprandial plasma Apolipoprotein B-48 (apoB-48) concentrations
timeFrame: Up to 5 hours post-meal.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: CINTESIS - Faculty of Medicine of the University of Porto
Study officials:
affiliation: CINTESIS, NOVA Medical School
name: Conceição Calhau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CINTESIS, Faculty of Medicine of the University of Porto
name: Luís Azevedo, PhD
role: PRINCIPAL_INVESTIGATOR
References: