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 Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health (NCT02042274), a na na study. The primary outcome is Blood Triglyceride.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02042274 |
| Phase | NA |
| Condition | Metabolic Syndrome X |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Guelph |
| Results posted | Yes |
2. Clinical Question
Population
The primary outcome description identifies healthy adults ranging in age from 18-65 years. The record also lists Metabolic Syndrome X as a condition. It does not explain how these two descriptions relate to the enrolled participants, or give further eligibility details; those details are not reported in the registry record.
Intervention
Participants received a fish oil supplement described as providing up to 3g per day of EPA and DHA. The outcome description specifies triglyceride measurements at baseline and after 3 months of supplementation, followed by measurement after a 2 month wash out period.
Comparator
The study is listed as a single-group study, with no randomized allocation and no separate comparison arm. It therefore does not describe a like-for-like control comparison. Any interpretation concerns measurements over time in the fish oil supplement group, not a contrast with an untreated or alternative-treatment group.
Primary question
The primary outcome is blood triglyceride concentration, measured in mmol/L. The stated question is whether triglyceride measurements differ across baseline, the end of supplementation, and the post-washout measurement. The registry record does not report the measured values or the analysis used to assess any changes.
The study’s stated broader purpose is to explore whether genetic make-up may modify responses to fish oil supplements. However, the registry record does not describe a genetic analysis, genetic subgroups, or results for such an analysis. The record also identifies Blood Glucose as a secondary outcome, but does not provide its measured values or analysis. Consequently, the stated aims can be described, but the posted information does not establish the size, direction, or precision of any change in either outcome. The small enrolled group and absence of a separate comparator are important context when considering what the design can show.
3. Trial Design
This is a completed, single-group study sponsored by the University of Guelph. The registry record lists enrollment of 12 participants, allocation as NA, and masking as none. It does not list a randomized assignment or a separate control group. The study is therefore described as observations within one fish oil supplement group rather than as a randomized comparison between groups. The phase is listed as NA.
The intervention is a dietary supplement: fish oil providing up to 3g per day of EPA and DHA. The primary outcome description specifies blood triglyceride measurements at baseline, after 3 months of supplementation, and after a 2 month wash out period. The listed primary outcome timeframe is Baseline, 3 months, 5 months. The record does not describe adherence assessment, dose adjustments, or the timing and procedures for the washout beyond that outcome description.
The registry lists a study start of 2012-10 and primary completion of 2013-03, with status completed. These dates describe the registry record’s study timeline; they do not supply additional outcome information. The record does not report recruitment details, participant flow, withdrawals, or the number contributing data at each measurement time.
Because no distinct comparator is listed, changes between measurements would not by themselves separate an intervention-related change from other influences over time. The record does not describe a statistical plan, a sample-size justification for this study, or interim analyses. Those design details are not reported in the registry record. Any planning illustrations based on two-arm assumptions should be understood as illustrations, not as a description of this single-group study’s design.
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 | Fish Oil Supplement |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Healthy adults, ranging in age from 18-65 years.
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 | Fish Oil |
|---|---|---|
| Participants analysed | 12 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 12 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 12 |
| Region of Enrollment: Canada | Participants | 12 |
| Triglycerides | mmol/L | 0.9 (SD 0.3) |
6. Primary Endpoint
The registry lists the primary outcome as Blood Triglyceride, measured over Baseline, 3 months, 5 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mmol/L |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is blood triglyceride concentration, expressed in mmol/L. Triglycerides are a type of blood lipid, and measuring their concentration gives a continuous outcome that can be summarized using a mean and a measure of spread. The registry specifies the mean as the outcome parameter and standard deviation as the dispersion measure. These choices describe how the endpoint is intended to be represented; they do not supply the actual observed mean or standard deviation.
Measurements are specified at baseline, after 3 months of supplementation, and after a 2 month wash out period. Repeated measurements can describe how a continuous measure changes within the observed group over time. The baseline measurement provides a point of reference for later measurements, while a post-washout measurement can describe the value after the stated washout interval. Without a separate comparator, these measurements cannot alone distinguish a change associated with the intervention from other changes over time.
The registry record does not report triglyceride values at any time point, the number measured at each time point, or an estimate of change. It also does not report confidence intervals, tests, or a model for this endpoint. Thus, the endpoint and intended measurement schedule are identifiable, but the observed pattern and its precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a study of 12 enrolled participants in one fish oil supplement group. It identifies blood triglycerides as the primary outcome and specifies measurement at baseline, after 3 months of supplementation, and after a 2 month wash out period. However, no numerical triglyceride results are reported. The record therefore does not establish whether the group mean rose, fell, or remained similar across those measurements, and it does not quantify the size or precision of a change.
The registry lists zero analyses. It does not provide the outcome means, standard deviations, participant counts at each measurement, estimated changes, confidence intervals, or p-values. Those results are not reported in the registry record. Without them, readers cannot assess how much the observations varied among participants or how compatible the data are with different possible changes. A planned schedule of measurements is not itself evidence of a particular result.
The single-group design also limits the interpretation of any change that might have been observed. A comparison of measurements over time in the same group would not provide a concurrent control for changes unrelated to supplementation. The record lists no randomized allocation and no like-for-like control comparison. Accordingly, even if numerical before-and-after results were available, the design would not support interpreting a time trend as an isolated intervention effect without additional assumptions.
The study’s broader purpose refers to possible modification of response by genetic make-up. No genetic results, subgroup definitions, or analyses are reported in the registry record. Blood Glucose is named as a secondary outcome, but its results are also not reported. The record therefore cannot answer whether responses differed by genetic characteristics or what pattern occurred for blood glucose.
The safety record lists 0 serious adverse events among 12 at risk and 0 other adverse events among 12 at risk in the fish oil supplement group. The death count is not reported in the registry record. These figures describe the reported event counts; they do not provide information about unreported events, event timing, or how completely safety outcomes were collected.
Overall, the posted information supports a description of the study question, intervention, outcome schedule, and design, but not an estimate of an outcome effect. No conclusion about the direction, magnitude, statistical uncertainty, or clinical importance of a triglyceride change can be drawn from the outcome information reported in the registry record.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
For a continuous endpoint such as blood triglyceride concentration, the mean describes the central value in a group. The standard deviation describes how dispersed individual measurements are around that mean. These are complementary summaries: a mean alone does not show how similar or different individual measurements are. In this record, mean and standard deviation are specified as the parameter and dispersion measure, but their observed values are not reported in the registry record.
What would repeated measurements contribute?
Measurements at baseline, after 3 months of supplementation, and after a 2 month wash out period make it possible to describe the group’s outcome at multiple times. Repeated measurements can be useful because each time point addresses a different stage in the stated schedule. A statistical analysis could summarize values at each time or estimate changes between times. The registry record does not report which approach was used, whether the same participants contributed at every time point, or how within-participant correlation was handled. Those analysis details are not reported in the registry record.
In general, measurements from the same person over time are related rather than independent. An analysis that accounts for that relationship can represent uncertainty differently from one that treats every measurement as unrelated. This is a general statistical consideration, not a description of the analysis conducted in this study. The registry record lists zero analyses and does not identify a repeated-measures model or other statistical method.
What does a confidence interval mean?
In general, a confidence interval is a range of values produced by a statistical procedure to express uncertainty about an estimate. A narrow interval indicates greater precision under the assumptions of the method; a wide interval indicates less precision. Its interpretation depends on the analysis and assumptions. No confidence interval or effect estimate for the triglyceride endpoint is reported in the registry record, so the precision of any change cannot be assessed.
A p-value, when reported, summarizes how unusual data at least as inconsistent with a specified null hypothesis would be under that hypothesis and the statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. No p-value or test for the primary outcome is reported in the registry record. The absence of a reported test is not evidence that a change was or was not present.
Why does the lack of a comparator matter?
In a randomized comparison, allocation can help make groups comparable in expectation, subject to the study’s conduct and size. This study is listed as single-group, with allocation NA and no separate comparator. A within-group change can describe what happened across scheduled measurements, but cannot by itself distinguish intervention-related change from time trends, measurement variation, or other influences. These are general design considerations; they are not claims that any particular alternative influence occurred in this study.
How should planning illustrations be read?
Sample-size planning asks how many participants might be needed for a future study under stated assumptions about an effect and the statistical procedure. The planning assumptions associated with the record specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, the stated convention is participants per arm for a power target; time-to-event illustrations use a total number of events. These are planning assumptions, not the design of this single-group study.
A planning illustration based on the observed effect is not an estimate of the study’s actual power. Power is a design quantity under specified assumptions and is not a measure of how likely a completed study’s result is to be true. The registry record does not report a study-specific sample-size justification, and a two-arm planning illustration does not turn this study into a two-arm comparison. No sample-size results or observed-effect estimates are reported in the registry record, so no numerical planning result can be interpreted.
Why can over-dispersion matter?
In general, over-dispersion means that observed variability is greater than a statistical model expects. When present, a model that understates variability can produce uncertainty estimates that are too small. Appropriate methods depend on the outcome and study design. The primary endpoint is described as a continuous measure summarized by a mean and standard deviation; the record does not report a model, a dispersion assessment, or an over-dispersion analysis. This general concept should not be mistaken for a finding about these data.
Overall, the registry identifies the endpoint, summary measure, timing, and broad design, but not the analysis specification or numerical results. Methods such as confidence intervals, repeated-measures models, or tests can only be interpreted for this study if their estimates and assumptions are reported; they are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies blood triglyceride as the primary outcome and Blood Glucose as a secondary outcome. It lists 2 outcome measures and zero analyses. The record does not report how many comparisons, time-point contrasts, or statistical tests were planned, nor whether any adjustment for multiple testing was intended. A multiplicity strategy is not reported in the registry record.
Multiplicity matters generally when several outcomes, time points, or subgroup comparisons are tested: the more opportunities to identify an apparently notable result, the more important it can be to account for the analysis plan and interpretation. This is a general issue and does not imply that a particular number of tests was performed in this study. Since no analyses or outcome results are listed, the effect of multiplicity on any reported inference cannot be evaluated.
Missing-data handling is also not described. The record does not state whether any participants missed a measurement, withdrew, or were excluded from an analysis, and it does not identify an imputation method or other approach for missing observations. The number contributing data at each outcome time is not reported in the registry record.
The analysis population is not specified. The enrollment count alone does not establish how many participants were included in each outcome analysis, especially across repeated measurements. No intention-to-treat, per-protocol, or other analysis population is identified in the registry record. These omissions mean that the completeness and scope of any outcome analysis cannot be assessed from the posted information.
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 |
|---|---|---|---|
| Fish Oil Supplement | 0 | 12 | 0.0% |
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 |
|---|---|
| Fish Oil Supplement | 0 of 12 |
The serious adverse event figures list 0 events among 12 participants at risk in the Fish Oil Supplement group. The other adverse event figures also list 0 events among 12 at risk. These are event counts as recorded for this group; they should not be read as a comparison with another group, because no separate comparator is listed.
The death count is not reported in the registry record. The record does not provide event descriptions, timing, duration of safety follow-up, or details of how events were collected. The absence of listed events does not establish that no events occurred outside the recorded categories or observation period. It describes only the posted counts.
Safety counts are also distinct from the primary endpoint. The serious and other adverse event figures do not provide information about changes in blood triglycerides or Blood Glucose. Because the record does not describe a comparator, these counts cannot be used to estimate a relative safety difference between interventions.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed, single-group study enrolled 12 participants and examined a fish oil supplement providing up to 3g per day of EPA and DHA. Blood triglycerides were the primary outcome, with measurements specified at baseline, after 3 months of supplementation, and after a 2 month wash out period. The record also names Blood Glucose as a secondary outcome and describes an overarching interest in whether genetic make-up may modify response.
Those design details do not establish what happened to the measured outcomes. No triglyceride or glucose values, estimated changes, standard deviations, confidence intervals, or statistical tests are reported in the registry record. The genetic question is also not accompanied by reported subgroup or genetic analyses. Therefore, the direction and size of any observed changes, and the precision of any estimate, remain unknown from the posted results.
The study’s single-group design does not include a like-for-like control comparison. In general, changes over time in one group can reflect the intervention, but can also reflect other influences or measurement variation. Without a comparator, those explanations cannot be separated by a between-group contrast. This is a design limitation, not evidence that any specific alternative explanation occurred.
The record also does not provide enough information to assess missing measurements, analysis populations, adherence, or the statistical methods used. The event counts describe no serious or other adverse events among 12 participants at risk in the listed group, while the death count is not reported. These safety entries do not fill the gap in the outcome results.
Accordingly, the registry record permits a clear description of the study’s intended question and measurement schedule, but it does not support a conclusion about the effect or clinical importance of supplementation. It also cannot establish whether genetic characteristics altered response. Such conclusions require outcome estimates and methods that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a research question and evidence that can answer it. The registry describes a question about blood triglycerides over time during and after fish oil supplementation. It also records a broader interest in genetic modification of response. However, the outcome results and analyses are not reported, so the stated question cannot be resolved from the posted information.
The single-group design is central to interpretation. Measurements at several times can describe the course of an outcome among participants, but a separate comparator is needed for a direct group contrast. Without one, a time pattern cannot isolate the intervention’s contribution from other influences. This distinction matters even when an outcome is measured repeatedly and the schedule is clearly specified.
The record also highlights why reporting estimates and uncertainty is essential. A stated mean and standard deviation indicate the planned way to summarize a continuous outcome, but without the observed values or an effect estimate, neither the magnitude nor precision of a change can be evaluated. A sample-size planning illustration under two-arm assumptions is not a substitute for the study’s actual design or its results.
Finally, the registry’s listed outcome measures, zero analyses, and incomplete reporting of missing-data and analysis-population details limit assessment of how the intended questions were examined. Clear outcome estimates, uncertainty measures, analysis methods, and participant counts at each time point would be needed to interpret the evidence. The record’s value is therefore in documenting the study’s aims and structure, while its posted results leave the statistical findings unreported.
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 record is that it does not report numerical results for the primary or secondary outcomes. Triglyceride and Blood Glucose values, estimates of change, variability, and uncertainty are not reported in the registry record. With zero analyses listed, there is no reported statistical result to evaluate.
The study is described as single-group, with allocation NA, masking none, and no separate control arm. Consequently, it does not provide a like-for-like comparison. The enrollment of 12 participants also defines the scale of the study, but the record does not state how many contributed measurements at each time point or to any analysis.
The population descriptions are not fully reconciled: the condition is listed as Metabolic Syndrome X, while the primary outcome description identifies healthy adults ranging in age from 18-65 years. The record does not explain the relationship between these descriptions or report further eligibility criteria. The genetic aim is not accompanied by a description of genetic measures or results. Blood Glucose is named as a secondary outcome, but its analysis is not reported.
Other details needed to evaluate the findings are not reported in the registry record, including the statistical plan, missing-data handling, analysis populations, adherence information, and sample-size justification for the study. The safety record lists zero serious and zero other adverse events among 12 at risk, but does not describe follow-up or provide a reported death count. These gaps constrain interpretation of both efficacy-related outcomes and safety reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy Study Regarding the Beneficial Effects of Omega-3 Fatty Acids on Cardiometabolic Health — NCT02042274.
- Registry record last updated 2017-04-05; status last verified 2017-02.
- Results first posted 2017-04-05.
- 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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18. Record Summary
The record describes a completed, single-group study sponsored by the University of Guelph, with 12 participants enrolled. The intervention was fish oil providing up to 3g per day of EPA and DHA. The primary outcome was blood triglyceride concentration in mmol/L, summarized as a mean with standard deviation, with measurements specified at baseline, after 3 months of supplementation, and after a 2 month wash out period.
Blood Glucose is listed as a secondary outcome, and the study’s broader aim concerns possible modification of response by genetic make-up. No outcome values, statistical analyses, or genetic findings are reported in the registry record. The listed safety counts are 0 serious and 0 other adverse events among 12 at risk; the death count is not reported. Because the design is single-group and numerical outcome results are absent, the direction, size, and precision of any outcome change cannot be assessed.