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

Phase 2

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Meal containing canned tuna + soybean oil; Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA)

• Registration Number: NCT03742492
• Lead Sponsor: Universidade do Porto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-05-27
• Last Update Posted: 2019-05-30
• Primary Completion: 2019-06
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Canned tuna + soybean oil	Meal containing canned tuna + soybean oil	Meal containing canned tuna + soybean oil
Canned tuna + fish oil (5 g EPA + DHA)	Meal containing canned tuna + fish oil (5 g EPA + DHA)	Meal containing canned tuna + fish oil (5 g EPA + DHA)

Primary Outcome Measures

Name	Time	Method
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 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).
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).

Secondary Outcome Measures

Name	Time	Method
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 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).
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 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).

Trial Locations

Locations (1)

CINTESIS - Faculty of Medicine of the University of Porto; 🇵🇹 Porto, Portugal