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Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals

NCT02148835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-09-24

Study results available
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Summary

New approaches to increase eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in our diet are needed, but any new approach needs to demonstrate the bioavailability of EPA+DHA, and its safety and palatability. The HS-Omega-3 Index is a prime parameter to demonstrate bioavailability in the long-term. Study hypothesis is that increased intake of EPA+DHA will increase the HS-Omega-3 Index. Study aim is to investigate how supplementing various sausages with omega-3 fatty acids influences the HS-Omega-3 Index in healthy volunteers, as compared to unsupplemented matching sausages. Safety and palatability of the sausages are also to be assessed.

Conditions

  • Healthy Volunteers

Interventions

OTHER

Sausage: Triomeg

Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates. sodium 0.66 g.

OTHER

Sausage: Control

Control sausage: as active, but no EPA+DHA ethyl-ester.

Sponsors & Collaborators

  • Südbayerische Fleischwaren GmbH

    collaborator UNKNOWN

  • Clemens von Schacky

    lead OTHER

Principal Investigators

  • Anton Köhler, MD · Ludwig-Maximilians - University of Munich

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148835 on ClinicalTrials.gov