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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03742492
• Other study ID #: FUNCTIONALTUNA1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 19, 2018
• Est. completion date: July 2019

Study information

• Verified date: April 2019
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Meal containing canned tuna + fish oil (5 g EPA + DHA)
Meal containing canned tuna + fish oil (5 g EPA + DHA)
• Meal containing canned tuna + soybean oil
Meal containing canned tuna + soybean oil

Locations

Country	Name	City	State
Portugal	CINTESIS - Faculty of Medicine of the University of Porto	Porto

Sponsors (3)

Lead Sponsor	Collaborator
Universidade do Porto	Center for Health Technology and Services Research, NOVA Medical School

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Project FUNCTIONALTUNA financed by COMPETE2020 (POCI-01-0247-FEDER-003466)