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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742492
Recruitment Status : Active, not recruiting
First Posted : November 15, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
Center for Health Technology and Services Research
NOVA Medical School
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Dietary Supplement: Meal containing canned tuna + fish oil (5 g EPA + DHA) Dietary Supplement: Meal containing canned tuna + soybean oil Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Bioavailability of EPA + DHA Enriched Canned Tuna and Its Acute Effects on Cardiovascular Risk Markers, in Healthy Human Volunteers
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




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

  2. Change in postprandial plasma low-density lipoprotein (LDL) cholesterol concentrations [ Time Frame: Up to 5 hours post-meal. ]
    Impact on the postprandial levels of LDL cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).

  3. Change in postprandial plasma total cholesterol concentrations [ Time Frame: Up to 5 hours post-meal. ]
    Impact on the postprandial levels of total cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).


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

  2. Change in postprandial plasma high-density lipoprotein (HDL) cholesterol concentrations [ Time Frame: Up to 5 hours post-meal. ]
    Impact on the postprandial levels of HDL cholesterol (0, 1, 2, 3, 4, and 5 hours post-meal).

  3. Change in postprandial plasma eicosapentaenoic acid (EPA) concentrations [ Time Frame: Up to 5 hours post-meal. ]
    Impact on the postprandial levels of EPA (0, 2, 4, and 5 hours post-meal).

  4. Change in postprandial plasma docosahexaenoic acid (DHA) concentrations [ Time Frame: Up to 5 hours post-meal. ]
    Impact on the postprandial levels of DHA (0, 2, 4, and 5 hours post-meal).

  5. Change in postprandial plasma blood glucose concentrations [ Time Frame: Up to 5 hours post-meal. ]
    Impact on the postprandial levels of blood glucose (0, 1, 2, 3, 4, and 5 hours post-meal).

  6. Change in postprandial plasma insulin concentrations [ Time Frame: Up to 5 hour post-meal. ]
    Impact on the postprandial levels of insulin (0, 1, 2, 3, 4, and 5 hours post-meal).

  7. Change in postprandial plasma Apolipoprotein B-48 (apoB-48) concentrations [ Time Frame: Up to 5 hours post-meal. ]
    Impact on the postprandial levels of ApoB-48 (0, 1, 2, 3, 4, and 5 hours post-meal).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742492


Locations
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Portugal
CINTESIS - Faculty of Medicine of the University of Porto
Porto, Portugal, 4200-450
Sponsors and Collaborators
Universidade do Porto
Center for Health Technology and Services Research
NOVA Medical School
Investigators
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Principal Investigator: Conceição Calhau, PhD CINTESIS, NOVA Medical School
Principal Investigator: Luís Azevedo, PhD CINTESIS, Faculty of Medicine of the University of Porto
Additional Information:
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03742492    
Other Study ID Numbers: FUNCTIONALTUNA1
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidade do Porto:
Omega-3 fatty acids
Eicosapentaenoic acid (EPA)
Docosahexaenoic acid (DHA)
Bioavailability
Blood pressure
Lipid absorption
Canned tuna