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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA); Dietary supplement: Meal containing canned tuna + soybean oil

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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; Meal containing canned tuna + soybean oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postprandial plasma triglycerides concentrations	Impact on the postprandial levels of triglycerides (0, 1, 2, 3, 4, and 5 hours post-meal).	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).	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).	Up to 5 hours post-meal.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postprandial blood pressure	Impact on the postprandial levels of blood pressure (0, 1, 2, 3, 4, and 5 hours post-meal).	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).	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).	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).	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).	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).	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).	Up to 5 hours post-meal.

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: NOVA Medical School; Center for Health Technology and Services Research
• Investigators: Principal Investigator: Luís Azevedo, PhD, CINTESIS, Faculty of Medicine of the University of Porto

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Bioavailability; Eicosapentaenoic acid (EPA); Docosahexaenoic acid (DHA); Omega-3 fatty acids; Blood pressure; Lipid absorption; Canned tuna
• Other Study ID Numbers: FUNCTIONALTUNA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No