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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA)
* Dietary Supplement: Meal containing canned tuna + soybean oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canned tuna + fish oil (5 g EPA + DHA)<br>Meal containing canned tuna + fish oil (5 g EPA + DHA) | Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA)<br>* Meal containing canned tuna + fish oil (5 g EPA + DHA)<br>|
| Placebo Comparator: Canned tuna + soybean oil<br>Meal containing canned tuna + soybean oil | Dietary Supplement: Meal containing canned tuna + soybean oil<br>* Meal containing canned tuna + soybean oil<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3 fatty acids, Eicosapentaenoic acid (EPA), Docosahexaenoic acid (DHA), Bioavailability, Blood pressure, Lipid absorption, Canned tuna