This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals (NCT02148835), a randomized na study. The primary outcome is HS-Omega-3 Index at Baseline and End of Study.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02148835 |
| Phase | NA |
| Condition | Healthy Volunteers |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 44 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Clemens von Schacky |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled healthy individuals, with the primary outcome population described as “As recruited.” The registry record does not report further participant characteristics or eligibility details. The listed enrollment is 44.
Intervention
The intervention was the Triomeg sausage, described in the study summary as a sausage supplemented with omega-3 fatty acids. The study aim was to examine how the sausages influenced the HS-Omega-3 Index and to assess safety and palatability.
Comparator
The comparator was a control sausage, described as an unsupplemented matching sausage in the study summary. The registry record does not provide further details about the sausages’ ingredients or how they were matched.
Primary question
The primary question was whether the HS-Omega-3 Index differed between the Triomeg and control sausage groups from baseline to the end of the study. The endpoint was recorded at baseline and 8 weeks. The registry record does not report the group means, standard deviations, or a statistical comparison, so the direction and precision of any difference cannot be assessed from that record.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group trial. Random allocation means that assignment to the Triomeg or control sausage group was intended to be determined by chance. In general, randomization can reduce systematic differences between groups at the start of a study, although it does not guarantee that every characteristic will be balanced, particularly in a small trial. The registry record does not describe the randomization sequence or concealment procedures.
Quadruple masking indicates that the record identifies four masked roles, but it does not name those roles or explain how masking was maintained. The word alone does not establish whether participants, study personnel, outcome assessors, or analysts remained unaware of assignment. The registry record does not report whether masking was assessed or whether it was broken.
The listed enrollment was 44, and the adverse-event record lists 22 participants at risk in each group. The trial status is completed. Its phase is recorded as not applicable. The sponsor is Clemens von Schacky. The study dates in the registry record are May 2014 for the start and December 2014 for primary completion.
The study summary describes an aim to investigate the effect of omega-3 fatty acids in various sausages compared with matching unsupplemented sausages. The intervention list identifies Triomeg and control sausage, but does not provide further details on the formulations, dose, or dietary instructions. Such details, along with the recruitment process and any protocol deviations, are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Triomeg | Control Sausage |
|---|---|---|
| STARTED | 22 | 22 |
| COMPLETED | 22 | 22 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: As recruited.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Triomeg | Control Sausage | Total |
|---|---|---|---|---|
| Participants analysed | 22 | 22 | 44 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 22 | 22 | 44 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 26.4 (SD 8.0) | 25.6 (SD 4.1) | 26.0 (SD 6.1) |
| Sex: Female, Male: Female | Participants | 9 | 6 | 15 |
| Sex: Female, Male: Male | Participants | 13 | 16 | 29 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Germany | Participants | 22 | 22 | 44 |
6. Primary Endpoint
The registry lists the primary outcome as HS-Omega-3 Index at Baseline and End of Study, measured over baseline and 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | HS-Omega-3 Index |
| Endpoint classification | Continuous Endpoint |
The primary outcome was the HS-Omega-3 Index at baseline and the end of the study, with the end-of-study time point specified as 8 weeks. It is defined in the registry record as the percentage of EPA+DHA in erythrocytes, measured using a highly standardized analytical procedure. The record states that the index correlates with tissue EPA+DHA and represents an individual’s EPA+DHA status.
This is a continuous measure, and the outcome was specified as a mean with standard deviation. In general, a mean describes the central value of a group, while a standard deviation describes how dispersed individual measurements are around that mean. The index was selected to assess longer-term bioavailability, according to the study summary. It therefore addresses whether the dietary intervention is reflected in this measured status indicator, rather than directly measuring every possible health outcome.
The registry record does not report the baseline or end-of-study means, standard deviations, or the change over time in either group. It also does not report a numerical between-group contrast. Without those estimates, the magnitude and precision of any observed change cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives the primary outcome’s definition and time points, but it does not give numerical outcome results. It lists the HS-Omega-3 Index at baseline and 8 weeks, yet reports no group means, standard deviations, changes, confidence intervals, or test results. Consequently, the direction, size, and statistical precision of the endpoint findings are not reported in the registry record.
The stated hypothesis was that increased EPA+DHA intake would increase the HS-Omega-3 Index. That hypothesis is not itself evidence that an increase occurred. To evaluate it from trial data, readers would need the observed measurements and a clearly defined comparison, such as the difference in change between randomized groups. Those results are not reported in the registry record. It is therefore not possible to conclude from this record whether the index increased in either group or whether changes differed between groups.
Even when group means are available, an apparent difference should be interpreted alongside uncertainty. A confidence interval, in general, describes a range of values compatible with the data and analysis assumptions. A narrow interval indicates greater precision than a wide interval, while an interval spanning values of different practical interpretations may leave uncertainty about the size or direction of an effect. No such interval is reported for this primary outcome.
The record lists no analyses. It does not report an adjusted estimate, an unadjusted estimate, or a method for handling the repeated baseline and end-of-study measurements. The analysis population and missing outcome data are also not described. These omissions prevent readers from determining how the primary endpoint was compared, how much data contributed, and whether the analysis followed a prespecified plan.
The adverse-event entries are descriptive safety counts, not evidence about the primary endpoint. They list no serious adverse events or deaths in either group, alongside counts for other adverse events. Those figures do not replace the missing outcome estimates, and they do not by themselves establish that the sausages were safe or unsafe. The registry record also names safety and palatability as study aims but does not provide palatability results.
The most defensible reading is therefore limited: this completed randomized study was designed to assess an omega-3 status measure over 8 weeks, but the registry record does not report the primary outcome results needed to quantify or interpret a group difference.
9. Statistical Methods Explained
The registry record identifies a continuous primary outcome summarized as a mean and standard deviation. For a continuous measure, the mean conveys the group’s average value, and the standard deviation conveys the spread of values around that average. Neither statistic alone describes how the randomized groups compare over time. For that, a contrast must be defined and estimated, with uncertainty reported if readers are to assess its precision.
Because the outcome was measured at baseline and at the end of the study, an analysis could in general compare end-of-study values, changes from baseline, or group differences over time. These approaches answer related but not identical questions and can rely on different assumptions. The registry record does not specify which approach was planned or used. It also does not report the values needed to reproduce or assess any such comparison. No particular analysis method should therefore be inferred from the outcome description alone.
Randomization supports a comparison between assigned groups, but the analysis still needs to account for the study design and clearly identify the population included. For example, readers need to know whether participants were analyzed according to their randomized assignment and how missing measurements were handled. These details are not reported in the registry record. Masking may reduce some risks of biased measurement or decisions, but the record does not explain which roles were masked or how the procedures worked.
In general, a confidence interval helps show the precision of an estimated effect. A p-value, when reported, addresses how compatible the data are with a specified null hypothesis under the analysis assumptions; it does not convey the size or clinical importance of an effect. Neither a confidence interval nor a p-value for the primary outcome is reported in the registry record. Statistical significance, if it had been reported, would not by itself establish the size, relevance, or reliability of a finding.
The study’s planning assumptions describe an illustration using a two-sided significance level of 0.05, equal allocation, and a normal approximation. They also describe planning for fractions of an observed effect. Such calculations are planning illustrations, not observed power and not evidence that the trial detected an effect. The registry record does not report the trial’s own sample-size justification, and the primary outcome estimates needed to assess the observed effect are not reported there.
In general, over-dispersion means that the observed variability is greater than a model assumes. It can make standard errors and confidence intervals based on that model unreliable if not accounted for. The listed primary outcome is continuous and summarized using a standard deviation; the registry record does not identify an over-dispersion issue or describe a model requiring such an adjustment. No special handling should be assumed.
Multiplicity concerns arise when several outcomes, time points, comparisons, or analyses are examined. Testing many hypotheses can increase the chance of findings that appear notable by chance if the analyses are not planned and interpreted appropriately. The registry record names a primary endpoint at baseline and end of study, and also lists safety and palatability as secondary aims. It does not provide a statistical analysis plan or describe any multiplicity procedure. There are no analyses listed in the record, so the actual number of inferential comparisons and any adjustment cannot be assessed.
Reproducible interpretation would require the group-level outcome summaries, a stated estimand or comparison, the analysis method, uncertainty estimates, the analysis population, and information on missing data. These elements are not reported in the registry record. The design and endpoint description explain what the trial set out to study, but do not supply the statistical results needed to judge the primary comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry record describes one primary outcome, the HS-Omega-3 Index, measured at baseline and 8 weeks. It also identifies safety and palatability as secondary aims. Multiple outcomes and time points can create multiplicity: the more comparisons examined, the greater the possibility that some may appear notable by chance. In general, a prespecified analysis plan can clarify which comparisons are primary and whether any adjustment is intended. No statistical analysis plan or multiplicity procedure is reported in the registry record.
The record lists no analyses. It does not state whether the primary comparison was based on change from baseline, an end-of-study value, or another approach. It also does not report whether any subgroup or other secondary comparisons were performed. Thus, the number and handling of inferential comparisons cannot be established from the registry record.
Missing data can affect both the estimate and its precision. In general, interpretation depends on how many measurements were available at each time point, why values were missing, and what assumptions were used in the analysis. The record does not report outcome completion, reasons for missing measurements, imputation, or a sensitivity analysis.
The analysis population is likewise not reported in the registry record. Although the trial is described as randomized, the record does not say whether analyses retained participants in their assigned groups or used another population. These omissions limit assessment of possible bias and reproducibility. They do not establish that data were missing or that a particular analysis was conducted; they mean those details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Triomeg | 0 | 22 | 0.0% |
| Control Sausage | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Triomeg | 0 of 22 |
| Control Sausage | 0 of 22 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Triomeg | 4 of 22 |
| Control Sausage | 2 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Triomeg | Control Sausage |
|---|---|---|---|
| Minor adverse event | Infections and infestations | 3 of 22 | 0 of 22 |
| Minor adverse events | Gastrointestinal disorders | 0 of 22 | 1 of 22 |
| Minor adverse event | Gastrointestinal disorders | 0 of 22 | 1 of 22 |
| Minor adverse event | Infections and infestations | 1 of 22 | 0 of 22 |
The adverse-event record lists 22 participants at risk in each group. It reports zero serious adverse events and zero deaths in the Triomeg group, and zero serious adverse events and zero deaths in the control sausage group. For other adverse events, the record lists 4 affected in the Triomeg group and 2 affected in the control sausage group.
These are counts as recorded, not rates calculated from the data. They should not be converted into a relative or percentage comparison without a specified analysis and careful attention to the event definitions and observation period. The registry record does not provide event descriptions, timing, duration, severity classifications for the other adverse events, or a comparison between groups. It also does not report whether all events were considered related to the sausages.
Zero recorded serious events does not establish that serious harms are impossible, and the other-event counts alone do not determine whether the groups differed meaningfully. The record lists safety as an assessment aim but does not report a fuller safety analysis. The listed figures therefore describe what was entered for the adverse-event categories; they do not establish an overall safety conclusion.
12. What the Result Does, and Does Not, Mean
This trial was designed to examine whether consuming Triomeg rather than a control sausage influenced the HS-Omega-3 Index in healthy individuals. The index was defined as the percentage of EPA+DHA in erythrocytes, and the primary outcome time points were baseline and 8 weeks. The design is relevant to a question about the measured omega-3 status indicator over the study period.
The registry record does not report the primary outcome values or a comparison between groups. As a result, it cannot show how much the index changed, whether changes differed between groups, or how precisely any difference was estimated. The study hypothesis—that increased EPA+DHA intake would increase the index—should not be mistaken for an observed result. The record also does not report palatability results, despite palatability being named as an assessment aim.
Even if an index difference were reported, it would describe the measured biomarker outcome and would not, by itself, establish an effect on health outcomes. The registry record characterizes the index as representing EPA+DHA status and correlating with tissue EPA+DHA. It does not report clinical outcomes that would establish broader health consequences. Generalization beyond the recruited healthy individuals would also require information about the enrolled participants and study context, which is not reported in the registry record.
The adverse-event entries provide limited descriptive information: no serious adverse events or deaths are listed in either group, while other adverse-event counts are listed for both. These entries do not substitute for outcome estimates or a complete safety assessment. Overall, the record supports understanding the question, design, endpoint, and some safety counts, but not a conclusion about the primary outcome’s direction, magnitude, or precision.
13. Why This Trial Matters Statistically
The trial illustrates why a clear endpoint description is not the same as a report of results. The registry record specifies an objective biomarker, its meaning, and measurement at baseline and 8 weeks. Yet without group summaries and a defined between-group estimate, readers cannot quantify the observed change or judge its uncertainty. A study can be designed around a measurable endpoint while still leaving the central statistical result unavailable in its registry record.
It also highlights the value of reporting how repeated measurements are analyzed. Comparing end values and comparing changes from baseline are not interchangeable in every circumstance. Stating the estimand, analysis population, missing-data approach, and uncertainty would help readers understand what the comparison means and whether it can be reproduced. Those details are not reported in the registry record.
The study’s randomization and masking are important design features, but they do not remove the need for transparent outcome reporting. Randomization concerns assignment; masking concerns awareness of assignments; neither alone supplies the effect estimate or guards against every source of bias. Reporting event counts likewise requires context about definitions, observation, and analysis.
Finally, the distinction between planning and findings matters. The record’s planning assumptions describe an illustration, not observed power or proof of a result. Statistical interpretation depends on the actual estimates and their precision. Here, the registry record leaves those central primary-outcome quantities unreported, so the design can be described more fully than its statistical findings can be evaluated.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting this trial from the registry record is the absence of primary outcome results. Although the endpoint and time points are defined, the record does not report group means, standard deviations, changes, confidence intervals, or a between-group comparison. This prevents an assessment of direction, magnitude, and precision.
The analysis plan is also not reported in the registry record. Readers cannot determine which comparison was intended, how the baseline measurement was incorporated, what population was analyzed, or whether adjustment for other factors was used. Missing outcome data and their handling are not reported, nor are sensitivity analyses. These details matter for judging the validity and reproducibility of a result.
Further limitations include the lack of reported participant characteristics, eligibility details, sausage formulation and dose information, and dietary instructions. The record does not explain the masking procedures or identify the roles masked. It names safety and palatability as aims but gives no palatability findings and only limited adverse-event details. These omissions constrain interpretation of implementation, generalizability, and tolerability.
The listed enrollment and adverse-event counts describe the trial record but do not resolve these gaps. The planning assumptions are not a substitute for a trial-specific sample-size justification or an outcome analysis. These limitations concern what is reported in the registry record; they do not establish that particular procedures or analyses were absent from the conduct of the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals — NCT02148835.
- Registry record last updated 2018-09-24; status last verified 2017-11.
- Results first posted 2018-09-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed randomized, quadruple-masked, parallel-group trial in healthy individuals, comparing Triomeg sausage with control sausage. The listed enrollment was 44. The primary endpoint was the HS-Omega-3 Index at baseline and 8 weeks, defined as the percentage of EPA+DHA in erythrocytes.
The primary outcome means, standard deviations, group comparison, and uncertainty estimates are not reported in the registry record. The record lists safety and palatability as secondary aims but provides no palatability results. Adverse-event entries list zero serious adverse events and zero deaths in both groups, and other adverse-event counts of 4 for Triomeg and 2 for control sausage. The registry record lists no analyses and does not describe missing-data handling or the statistical analysis plan.