Healthy Volunteers
Conditions
Keywords
Omega-3 Index, Bioavailability, Eicosapentaenoic acid, Docosahexaenoic acid, Fortified food
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.
Interventions
OTHERSausage: 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.
OTHERSausage: Control
Control sausage: as active, but no EPA+DHA ethyl-ester.
Sponsors
Südbayerische Fleischwaren GmbH
Clemens von Schacky
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HS-Omega-3 Index at Baseline and End of Study | baseline and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Palatability of the Study Sausage | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 22 |
| Control Sausage Sausage: Control
Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester. | 22 |
| Control Sausage Sausage: Control
Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester. | 22 |
| Total | 88 |
Baseline characteristics
| Characteristic | Triomeg | Control Sausage | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Age, Continuous | 26.4 years STANDARD_DEVIATION 8 | 25.6 years STANDARD_DEVIATION 4.1 | 26.0 years STANDARD_DEVIATION 6.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Germany | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 4 / 22 | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
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.
Time frame: baseline and 8 weeks
Population: As recruited.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Triomeg | HS-Omega-3 Index at Baseline and End of Study | baseline | 4.18 HS-Omega-3 Index | Standard Deviation 0.54 |
| Triomeg | HS-Omega-3 Index at Baseline and End of Study | 8 weeks | 5.72 HS-Omega-3 Index | Standard Deviation 0.66 |
| Control Sausage | HS-Omega-3 Index at Baseline and End of Study | baseline | 4.32 HS-Omega-3 Index | Standard Deviation 0.35 |
| Control Sausage | HS-Omega-3 Index at Baseline and End of Study | 8 weeks | 4.50 HS-Omega-3 Index | Standard Deviation 0.51 |
Secondary
Safety and Palatability of the Study Sausage
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.
Time frame: 10 weeks