Healthy VolunteersNCT02148835
Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals
A study testing Sausage: Triomeg in people with Healthy Volunteers, run by Clemens von Schacky at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sausage: Triomeg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 serious bleeding disorder. Use of platelet inhibitors or conventional anticoagulation with a target INR of 2.0 - 3.0 is not an exclusion criterion.
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Preventive Cardiology, Ludwig Maximilians-University Munich
Munich, Bavaria, 80336
About this study
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.
Read the 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
- Being tested
- Sausage: Triomeg, Sausage: Control
- Keywords
- Omega-3 Index, Bioavailability, Eicosapentaenoic acid, Docosahexaenoic acid, Fortified food
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sausage: ControlOther
Control sausage: as active, but no EPA+DHA ethyl-ester.
| Study group | Role | What they receive |
|---|---|---|
| Triomeg | Active comparator | Sausage: Triomeg Receives: Other: Sausage: Triomeg |
| Control sausage | Placebo comparator | Sausage: Control Receives: Other: Sausage: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 8 weeks
Secondary outcomes (1)
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemens von Schacky
- Sponsor type
- University, hospital or other
- Collaborators
- Südbayerische Fleischwaren GmbH
- Responsible party
- Sponsor-investigator, Clemens von Schacky, Ludwig-Maximilians - University of Munich
- Investigators
- Anton Köhler, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148835
- Sponsor's protocol ID
- 543-13
- Status last verified
- Nov 2017
- First submitted
- 23 May 2014
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02148835
- Acronym / sponsor ID
- 543-13
- Conditions
- Healthy Volunteers
- Keywords
- Omega-3 Index, Bioavailability, Eicosapentaenoic acid, Docosahexaenoic acid, Fortified food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Clemens von SchackyUniversity, hospital or other
- Collaborators
- Südbayerische Fleischwaren GmbH
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 24 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triomeg | Active comparator | Other: Sausage: TriomegSausage: Triomeg |
| Control sausage | Placebo comparator | Other: Sausage: ControlSausage: Control |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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 serious bleeding disorder. Use of platelet inhibitors or conventional anticoagulation with a target INR of 2.0 - 3.0 is not an exclusion criterion.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sausage: TriomegCommercial 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. | Other | Triomeg |
| Sausage: ControlControl sausage: as active, but no EPA+DHA ethyl-ester. | Other | Control sausage |
Primary outcome
HS-Omega-3 Index at Baseline and End of Study
Time frame: 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.
1 secondary outcome
Safety and Palatability of the Study Sausage
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Köhler, MD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sausage: Triomeg in people with Healthy Volunteers, run by Clemens von Schacky at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HS-Omega-3 Index at Baseline and End of Study (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.