Trial Outcomes & Findings for Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals (NCT NCT02148835)

Last Updated: 2018-09-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2018-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Triomeg Sausage: Triomeg 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.	Control Sausage Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester.
Overall Study STARTED	22	22
Overall Study COMPLETED	22	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triomeg n=22 Participants Sausage: Triomeg 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.	Control Sausage n=22 Participants Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester.	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=44 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=22 Participants	22 Participants n=22 Participants	44 Participants n=44 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants	0 Participants n=22 Participants	0 Participants n=44 Participants
Age, Continuous	26.4 years STANDARD_DEVIATION 8.0 • n=22 Participants	25.6 years STANDARD_DEVIATION 4.1 • n=22 Participants	26.0 years STANDARD_DEVIATION 6.1 • n=44 Participants
Sex: Female, Male Female	9 Participants n=22 Participants	6 Participants n=22 Participants	15 Participants n=44 Participants
Sex: Female, Male Male	13 Participants n=22 Participants	16 Participants n=22 Participants	29 Participants n=44 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	22 Participants n=22 Participants	22 Participants n=22 Participants	44 Participants n=44 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: As recruited.

Outcome measures

Outcome measures
Measure	Triomeg n=22 Participants Sausage: Triomeg 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.	Control Sausage n=22 Participants Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester.
HS-Omega-3 Index at Baseline and End of Study baseline	4.18 HS-Omega-3 Index Standard Deviation 0.54	4.32 HS-Omega-3 Index Standard Deviation 0.35
HS-Omega-3 Index at Baseline and End of Study 8 weeks	5.72 HS-Omega-3 Index Standard Deviation 0.66	4.50 HS-Omega-3 Index Standard Deviation 0.51

SECONDARY outcome

Timeframe: 10 weeks

Serious adverse events (SAE) not necessarily ending study participation are: * hospitalizations and surgical procedures * life-threatening events and accidents * Events leading to permanent damage to study participants, Moreover, all other medical events will be recorded. All events qualifying as AE or SAE, according to Good Clinical Practice, will be recorded and reported to the ethic´s committee.

Outcome measures

Outcome data not reported

Adverse Events

Triomeg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Control Sausage

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Triomeg n=22 participants at risk Sausage: Triomeg 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.	Control Sausage n=22 participants at risk Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester.
Gastrointestinal disorders Minor adverse events	0.00% 0/22 • 10 Weeks	4.5% 1/22 • Number of events 1 • 10 Weeks
Gastrointestinal disorders Minor adverse event	0.00% 0/22 • 10 Weeks	4.5% 1/22 • Number of events 1 • 10 Weeks
Infections and infestations Minor adverse event	13.6% 3/22 • Number of events 3 • 10 Weeks	0.00% 0/22 • 10 Weeks

Additional Information

Prof. Dr. C. von Schacky

Preventive Cardiology, University of Munich

Phone: +49 89 44005 2165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place