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

NCT03742492 | Unknown Phase 2

• 1 other identifier: FUNCTIONALTUNA1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Omega-3 fatty acids; Eicosapentaenoic acid (EPA); Docosahexaenoic acid (DHA); Bioavailability; Blood pressure; Lipid absorption; Canned tuna

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in postprandial blood pressure

  Up to 5 hours post-meal.

• Change in postprandial plasma high-density lipoprotein (HDL) cholesterol concentrations

  Up to 5 hours post-meal.

• Change in postprandial plasma eicosapentaenoic acid (EPA) concentrations

  Up to 5 hours post-meal.

• Change in postprandial plasma docosahexaenoic acid (DHA) concentrations

  Up to 5 hours post-meal.

• Change in postprandial plasma blood glucose concentrations

  Up to 5 hours post-meal.

Study Arms (2)

Canned tuna + fish oil (5 g EPA + DHA)

EXPERIMENTAL

Meal containing canned tuna + fish oil (5 g EPA + DHA)

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

Canned tuna + soybean oil

PLACEBO COMPARATOR

Meal containing canned tuna + soybean oil

Dietary Supplement: Meal containing canned tuna + soybean oil

Interventions

Meal containing canned tuna + fish oil (5 g EPA + DHA) DIETARY_SUPPLEMENT

Meal containing canned tuna + fish oil (5 g EPA + DHA)

Canned tuna + fish oil (5 g EPA + DHA)

Meal containing canned tuna + soybean oil DIETARY_SUPPLEMENT

Meal containing canned tuna + soybean oil

Canned tuna + soybean oil

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Center for Health Technology and Services Research: collaborator
• NOVA Medical School: collaborator

Study Sites (1)

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

Location

Related Links

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

MeSH Terms

Interventions

Fish Oils; Soybean Oil

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Conceição Calhau, PhD

  CINTESIS, NOVA Medical School

  PRINCIPAL INVESTIGATOR

• Luís Azevedo, PhD

  CINTESIS, Faculty of Medicine of the University of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 15, 2018
• Study Start: September 19, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-04

Locations

PT (1)