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

NCT ID: NCT02148835

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-12-31

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.

Detailed Description

Randomized, placebo-controlled, mono-center comparison of two matching groups of sausages (active vs. control). The study will be conducted according to Good Clinical Practice. Randomization will be computer-generated by the sponsor. Sealed envelopes will be provided to the Investigator bearing individual randomization numbers, containing individual randomization results. Thus, in case of need, one sealed envelope can be opened to learn the randomization result of one patient without overall unblinding.

Study participants will be requested to ingest approx. 80 g / day of the experimental sausages during the day at a time of their convenience. Study participants will be provided with the investigational product free of charge. If necessary, the investigational product will be shipped to study participants. Study participants will receive the exact amount of sausages to complete the study.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Triomeg

Sausage: Triomeg

Group Type: ACTIVE_COMPARATOR

Sausage: Triomeg

Intervention Type: OTHER

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.

Control sausage

Sausage: Control

Group Type: PLACEBO_COMPARATOR

Sausage: Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Sausage: Control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects must be willing to eat 80 g of the sausage to be investigated per day.

2. Age: 20 - 60 years

3. Low HS-Omega-3 Index (<5%)

4. Subjects must have adequate fluency in German or English to complete baseline and follow-up interviews.

5. Stable intake of food containing EPA+DHA before and during study

6. Subjects must be able and willing to give written informed consent, and to comply with study procedures.

Exclusion Criteria

1. 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.

2. Subjects consuming >2 portions of fatty fish / week

3. Subjects with serious bleeding disorder. Use of platelet inhibitors or conventional anticoagulation with a target INR of 2.0 - 3.0 is not an exclusion criterion.

4. Subjects with any acute and life-threatening condition, such as collapse and shock, acute myocardial infarction (last three months), stroke, embolism.

5. Subjects with significant medical co-morbidity, seriously limiting life expectancy or insulin-treated diabetes mellitus or a BMI>30

6. Allergy/intolerance or history of hypersensitivity to components of study intervention.

7. Pregnant subjects and breastfeeding subjects. In addition, women of childbearing potential who will not practice a medically accepted method of contraception will be excluded.

8. 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.

9. Use of any investigational agents within 30 days prior to t0

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Südbayerische Fleischwaren GmbH

UNKNOWN

Sponsor Role: collaborator

Clemens von Schacky

OTHER

Sponsor Role: lead

Responsible Party

Clemens von Schacky

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anton Köhler, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Dept. of Preventive Cardiology, Ludwig Maximilians-University Munich

Munich, Bavaria, Germany

Countries

Germany

Other Identifiers

543-13

Identifier Type: -

Identifier Source: org_study_id