NCT02148835

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 24, 2018

Completed
Last Updated

September 24, 2018

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

May 23, 2014

Results QC Date

July 12, 2017

Last Update Submit

November 29, 2017

Conditions

Healthy Volunteers

Keywords

Omega-3 IndexBioavailabilityEicosapentaenoic acidDocosahexaenoic acidFortified food

Outcome Measures

Primary Outcomes (1)

  • HS-Omega-3 Index at Baseline and End of Study

    The HS-Omega-3 Index is the percentage of EPA+DHA in erythrocytes, as assessed with a highly standardized analytical procedure. Since the HS-Omega-3 Index correlates with tissue EPA+DHA, it represents an individual's status in EPA+DHA.

    baseline and 8 weeks

Secondary Outcomes (1)

  • Safety and Palatability of the Study Sausage

    10 weeks

Study Arms (2)

Triomeg

ACTIVE COMPARATOR

Sausage: Triomeg

Other: Sausage: Triomeg

Control sausage

PLACEBO COMPARATOR

Sausage: Control

Other: Sausage: Control

Interventions

Sausage: TriomegOTHER

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.

Triomeg
Sausage: ControlOTHER

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

Control sausage

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must be willing to eat 80 g of the sausage to be investigated per day.
  • Age: 20 - 60 years
  • Low HS-Omega-3 Index (\<5%)
  • Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.
  • Stable intake of food containing EPA+DHA before and during study
  • Subjects must be able and willing to give written informed consent, and to comply with study procedures.

You may not qualify if:

  • Subjects for whom the intake of omega-3 fatty acids is mandatory according to recent treatment guidelines or who take omega-3 fatty acids supplements on a regular basis.
  • Subjects consuming \>2 portions of fatty fish / week
  • Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.
  • Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitus or a BMI\>30
  • Allergy/intolerance or history of hypersensitivity to components of study intervention.
  • Pregnant subjects and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.
  • Subjects who, in the investigator's judgement, will not likely be able to comply with the study protocol or with known drug- or alcohol abuse/dependence in the past 2 years.
  • Use of any investigational agents within 30 days prior to t0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Preventive Cardiology, Ludwig Maximilians-University Munich

Munich, Bavaria, 80336, Germany

Location

Results Point of Contact

Title
Prof. Dr. C. von Schacky
Organization
Preventive Cardiology, University of Munich
clemens.vonschacky@med.uni-muenchen.de
+49 89 44005 2165

Study Officials

  • Anton Köhler, MD

    Ludwig-Maximilians - University of Munich

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 28, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 24, 2018

Results First Posted

September 24, 2018

Record last verified: 2017-11

Locations

DE(1)