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| Name | Class |
|---|---|
| Südbayerische Fleischwaren GmbH | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triomeg | Active Comparator | Sausage: Triomeg |
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| Control sausage | Placebo Comparator | Sausage: Control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sausage: Triomeg | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Palatability of the Study Sausage | Serious adverse events (SAE) not necessarily ending study participation are:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anton Köhler, MD | Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Preventive Cardiology, Ludwig Maximilians-University Munich | Munich | Bavaria | 80336 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Sausage | Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | As recruited. | Posted | Mean | Standard Deviation | HS-Omega-3 Index | baseline and 8 weeks |
|
10 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor adverse events | Gastrointestinal disorders | Systematic Assessment | One participant had mild GI symptoms not related to the investigational product, considered not related to the investigational product. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. C. von Schacky | Preventive Cardiology, University of Munich | +49 89 44005 2165 | clemens.vonschacky@med.uni-muenchen.de |
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| Sausage: Control | Other | Control sausage: as active, but no EPA+DHA ethyl-ester. |
|
| 10 weeks |
| BG001 | Control Sausage | Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| Control Sausage |
Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester. |
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| Secondary | Safety and Palatability of the Study Sausage | Serious adverse events (SAE) not necessarily ending study participation are:
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. | Not Posted | 10 weeks | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 4 |
| 22 |
| EG001 | Control Sausage | Sausage: Control Sausage: Control: Control sausage: as active, but no EPA+DHA ethyl-ester. | 0 | 22 | 0 | 22 | 2 | 22 |
|
| Minor adverse event | Gastrointestinal disorders | Systematic Assessment | One participant had a viral infection with fever, diarrhea and emesis, considered not related to the investigational product. |
|
| Minor adverse event | Infections and infestations | Systematic Assessment | One participant had influenza, considered not related to the investigational product. |
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| Minor adverse event | Infections and infestations | Systematic Assessment | Three participants had mild symptoms of a cold, considered not related to the investigational product. |
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