Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels (NCT00441480), a randomized phase 4 study. The primary outcome is LDL Cholesterol.

2. Clinical Question

This distinction matters when interpreting the numerical result. Randomization can support a comparison of assigned interventions when outcomes are measured after exposure and analyzed accordingly. Here, the posted primary measurement is explicitly identified as baseline. It therefore does not, by itself, answer whether the intervention changed LDL cholesterol relative to corn oil. The registry record does not report a treatment-period primary analysis.

3. Trial Design

The registry describes a phase 4, randomized, quadruple-masked, parallel-group study. Enrollment was 91, and the record lists the study as completed. The sponsor was Enzymotec. The study start is recorded as 2007-03 and primary completion as 2008-06. These registry descriptors give the broad structure of the study, but they do not establish details beyond those recorded.

Participants were assigned to plant sterol esters or placebo. The intervention arm is also identified as PS-FO, with the description plant sterols esterified to fish oil fatty acids; the control arm is described as corn oil. The record calls both interventions dietary supplements. The term quadruple masking is reported, but the roles of the masked parties are not reported in the registry record.

The primary outcome is LDL cholesterol in mg/dl, summarized as a mean with standard deviation. Its timeframe is listed as at baseline, and the description specifies an average of blood test results at -10 and 0 days, before and after the run-in period. The primary analysis population description says that subjects with a body-weight change of more than 3 kg from baseline during the interventions or compliance below 65% were excluded before the randomization code was broken. The registry does not report the full flow of participants through enrollment, assignment, follow-up, and analysis, or the exact reasons for each difference between reported group sizes.

The posted primary comparison includes 34 participants in PS-FO and 33 in control. Safety summaries list 46 and 45 at risk, respectively. Those distinct counts relate to different posted summaries; the registry record does not explain their relationship in detail. The original study protocol, the trial's own sample-size justification, and further design or analysis procedures 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.

Before assignment: 10 -14 days run-in phase during which they received placebo capsules. Run-in phase enabled to exclude subjects who had an unstable weight (gained or lost more than 3 kg) during this period or who didn't meet entry criteria of LDL-c and TG at screening visit and at baseline visit.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Subjects whose body weight were changed from baseline value by more than 3 kg during the interventions or had compliance below 65% were excluded from analysis before breaking the randomization code. It was done since these changes may have a significant influence on the study end points

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.

6. Primary Endpoint

The registry lists the primary outcome as LDL Cholesterol, measured over at baseline.

The primary endpoint is LDL cholesterol, measured in mg/dl and summarized as a mean and standard deviation. LDL cholesterol is a blood lipid measurement, and it was selected as the primary outcome in a study whose stated purpose was to assess the lipid profile, predominantly LDL cholesterol and triglyceride concentrations. As the primary measure, it is the outcome the registry identifies as central to the study question.

The endpoint's recorded timing is important for its interpretation. The registry labels the timeframe at baseline and describes the value as the average of blood test results at -10 and 0 days, before and after the run-in period. This is not described as a measurement of change from baseline or as an end-of-intervention value. The reported group means and comparison therefore represent a starting-point comparison as labeled in the record.

The primary population description states that subjects whose body weight changed by more than 3 kg from baseline during the interventions, or whose compliance was below 65%, were excluded from analysis before the randomization code was broken. This describes a restriction on the analysis population, but the record does not report the full participant flow or explain all analysis-population decisions. It also does not report a post-intervention primary endpoint analysis. The posted baseline endpoint can describe the groups' recorded LDL cholesterol at baseline; it cannot establish the amount of change during the intervention.

7. Results Posted in the Registry

• PS-FO: mean 159.70 versus 157.80 on control; difference 1.90 (95% CI -5.95 to 9.75), standardized effect d = 0.12; z-test p = 0.635.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Triglycerides

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • PS-FO: mean 244.90 versus 248.90 on control; difference -4.00 (95% CI -39.78 to 31.78), standardized effect d = -0.05; z-test p = 0.827.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PS-FO and the control. The interval gives the range of effects that remain compatible with the data.

Total Cholesterol

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • PS-FO: mean 244.30 versus 239.60 on control; difference 4.70 (95% CI -6.65 to 16.05), standardized effect d = 0.20; z-test p = 0.417.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PS-FO and the control. The interval gives the range of effects that remain compatible with the data.

HDL Cholesterol

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • PS-FO: mean 46.00 versus 44.20 on control; difference 1.80 (95% CI -2.23 to 5.83), standardized effect d = 0.21; z-test p = 0.382.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PS-FO and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results cover triglycerides, total cholesterol, and HDL cholesterol. Each is reported as a continuous measure with group means and standard deviations, and each comparison is labeled at baseline. Their overall role is to add context about starting lipid measurements across the two groups. They do not provide independent evidence about how the intervention changed these outcomes, because the posted timeframes do not describe post-intervention measurements or changes.

The broad pattern is that the reported group means are relatively close in the posted summaries, and the corresponding unadjusted comparisons do not show clear evidence of baseline differences. This is consistent with the primary result being a baseline comparison rather than a treatment response. It should not be interpreted as showing that treatment effects were similar across outcomes: the registry does not provide those treatment-period comparisons.

The registry lists CRP among the secondary outcomes, but a corresponding result is not reported in the posted secondary comparisons. The listed secondary outcomes include repeated labels for some measures, while the posted outcome summaries do not provide a treatment-period analysis for those measures. No conclusions about unposted results can be drawn from the list alone.

Unadjusted secondary results carry less weight because several outcomes may be examined, increasing the opportunity for apparently notable results to arise by chance. In general, multiplicity procedures can account for multiple comparisons, but no such procedure is reported. The secondary comparisons are also not identified as sponsor-reported analyses. They should therefore be viewed as descriptive and exploratory, especially given their baseline timing. They can help characterize the data recorded in the registry, but they do not strengthen a claim of intervention benefit or establish a coherent treatment effect across lipid measures.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Triglycerides
• Triglycerides
• Total Cholesterol
• Total Cholesterol
• HDL Cholesterol
• HDL-cholestrol
• CRP
• CRP

9. Statistical Interpretation

10. Statistical Methods Explained

The posted continuous outcomes are summarized by group means and standard deviations. A mean describes the center of the recorded measurements, while a standard deviation describes how spread out individual measurements are around that mean. These summaries are useful for comparing groups, but they do not show the shape of the individual-level data or disclose whether unusual values influenced the averages.

What does the mean difference represent?

For the primary comparison, the reported mean difference is 1.9 mg/dl, with PS-FO compared with control. In general, a mean difference expresses the difference between the group averages in the units of the outcome. Here, because the outcome is labeled at baseline, this is a baseline contrast, not an estimate of the effect of taking the intervention. The distinction between a group contrast and a treatment effect depends on when the outcome was measured and what comparison was analyzed.

The posted standard deviations are 17.22 mg/dl for PS-FO and 15.54 mg/dl for control. Such within-group spread is different from uncertainty about the difference between group means. The latter is conveyed by the interval accompanying the mean difference. A confidence interval is, in general, a range of estimates compatible with the data and the method used to calculate it. The registry record does not state the confidence level in the registry record, so the interval is referred to simply as the posted interval.

How should the p-value be understood?

The unadjusted p-value for the primary comparison is 0.635. In general, a p-value summarizes how compatible the observed data are with a specified null model, assuming that model and the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The p-value is described as unadjusted because it is not reported as adjusted for multiple comparisons. The registry record does not report a multiplicity procedure.

Statistical evidence and practical importance are separate questions. The estimated difference is in the outcome's original units, while the interval conveys its uncertainty. A result can fail to provide clear evidence against a no-difference model and still be too imprecise to rule out differences of interest. Conversely, statistical significance alone would not establish importance. No threshold for a clinically important LDL cholesterol difference is reported in the registry record.

Why does the endpoint timing matter?

In a randomized study, comparing measurements after assignment can address intervention groups, provided the analysis and timing match the question. A baseline measurement is ordinarily used to describe initial status or to support an analysis of later outcomes. The posted result is identified as a baseline average, specifically blood test results at -10 and 0 days around the run-in period. It is not presented as a change score, follow-up value, or treatment-period contrast. Therefore, interpretation must remain at the level of baseline group measurements.

The primary population description indicates exclusions for body-weight changes of more than 3 kg during the interventions or compliance below 65%, before the randomization code was broken. In general, excluding participants after assignment can affect how well an analysis represents the randomized groups, particularly when exclusion is related to outcomes or differs between groups. The record does not provide the participant-level reasons, group-specific exclusion counts, or an analysis including all randomized participants, so the consequences cannot be determined from the posted record.

What is meant by over-dispersion?

For continuous outcomes, variability is commonly summarized using a standard deviation. In general, over-dispersion refers to greater variability than a statistical model assumes. It can make standard errors too small and intervals too narrow if the model does not allow for the extra variation. The posted summaries do not report an over-dispersion assessment, and the trial's original model checks are not reported in the registry record. This is a general statistical consideration rather than a specific finding about this study.

The comparisons include pooled standard deviations and standardized effect-size values, but the most direct interpretation remains the mean difference in mg/dl. Standardized measures express a difference relative to a scale of variability and can support planning or comparisons across measures; they do not change the endpoint's timing or convert a baseline difference into a treatment effect. The registry record does not report a sponsor analysis for the secondary measures.

Finally, the planning illustrations use stated assumptions for a normal-approximation calculation. These are hypothetical design calculations based on the observed effect, not the trial's original design justification. The original sample-size assumptions and any interim analyses are not reported in the registry record. The distinction between a planning calculation and an analysis of observed trial outcomes is essential: the former describes what a future study might require under stated assumptions, while the latter describes the data collected in this study.

11. Confidence Intervals and Precision

The primary mean difference is 1.9 mg/dl, and its posted interval extends from -5.949 to 9.749. This range includes zero and also includes values in either direction. In practical terms, the estimate alone should not be treated as a precise statement that the groups had identical LDL cholesterol, nor as evidence of a definite difference. The interval communicates uncertainty around the estimated baseline contrast.

Confidence intervals are useful because they show a range of values consistent with the data and the calculation method, rather than presenting only a single estimate. Here, the posted range is broad enough to span lower and higher baseline LDL cholesterol in PS-FO relative to control. The registry record does not report the confidence level for the posted interval, so no level is assigned.

Precision is affected by the amount of information available and the variability in the measurements. The primary comparison reports 34 participants in PS-FO and 33 in control, with standard deviations of 17.22 and 15.54 mg/dl. These counts and spreads help contextualize why the estimate has uncertainty, but they do not by themselves establish whether the interval excludes differences that would matter clinically. A threshold for a clinically important difference is not reported in the registry record.

Most importantly, statistical precision cannot compensate for a mismatch between the endpoint timing and the treatment question. Even a narrow interval around a baseline contrast would not estimate a treatment-period effect. The posted interval describes uncertainty in the baseline comparison; it is not an interval for change in LDL cholesterol during the intervention.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size display is a planning illustration, not a report of the study's original design calculation. For these continuous outcomes, the figures are participants per arm, not total events. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning row uses a stated fraction of the observed effect as the effect to detect.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and assumptions were correct. The 90% power column gives the corresponding planning target for a 90% chance. These are design probabilities under a model, not guarantees about the result of a future study. This is not observed power.

Rows that plan for a smaller effect require more participants per arm. That is because a smaller difference is harder to distinguish from random variation when measurement variability is otherwise similar. The table shows this pattern by comparing planning for 100%, 75%, and 50% of the observed effect. The figures should be read as hypothetical targets tied to those effect assumptions, rather than as recommended enrollment numbers or proof that the observed trial was adequately or inadequately sized.

The original trial's sample-size justification, its target effect, and its own design assumptions are not reported in the registry record. The planning illustration therefore cannot be used to infer what the investigators intended when they designed the study. Since the posted outcomes are labeled at baseline, the observed contrasts used for the illustration also should not be mistaken for treatment effects.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 1.900; pooled standard deviation σ = 16.414.
2. n = 2 × (1.96 + 0.842)² × 16.414² / 1.900² = 1,171.6, rounded up to 1,172 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.89999999999998                      # observed difference in means
sigma <- 16.4144253630762                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(441480)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1,172 (80% power), 1,569 (90% power)
 75% of observed effect: n per arm = 2,083 (80% power), 2,789 (90% power)
 50% of observed effect: n per arm = 4,687 (80% power), 6,274 (90% power)
power.t.test: 1172.6 
Simulated power at n = 1,172 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The record lists multiple secondary outcomes and reports unadjusted p-values for the posted continuous comparisons. It does not report a multiplicity adjustment, a prespecified hierarchy for testing outcomes, or a procedure for controlling the chance of false-positive findings across multiple comparisons. The trial's statistical analysis plan is not reported in the registry record.

This matters because examining multiple outcomes can produce chance findings even when no true differences exist. In general, multiplicity methods modify interpretation or testing to account for the number and structure of comparisons. Without a reported approach, the secondary p-values should be treated as unadjusted rather than as confirmatory evidence. The primary outcome is designated, but the record does not provide enough information to establish how the study handled all planned tests.

Missing-data methods are also not reported in the registry record. The posted primary description identifies exclusions based on body-weight change of more than 3 kg during the interventions or compliance below 65%, before the randomization code was broken. It does not give group-specific counts or reasons for all participants absent from the primary analysis, nor does it describe imputation or sensitivity analyses. The posted result therefore cannot show how alternative handling of missing or excluded observations would affect the estimate.

The registry reports 91 enrolled, whereas the primary comparison lists 34 in PS-FO and 33 in control, and the safety summaries list 46 and 45 at risk. These figures refer to different posted summaries. The record does not provide a detailed accounting that reconciles the analysis populations or explains all differences. In general, analyses restricted after randomization can differ from analyses that retain all randomized participants. The registry's exclusion description makes the analysis population especially relevant, but the record does not report an intention-to-treat analysis or enough information to assess the effect of exclusions.

Interim analyses, stopping rules, and the trial's original sample-size justification are not reported in the registry record. Their absence from the record should not be taken to mean that they did or did not occur. It limits what can be said about the prespecified statistical plan and how completely the posted results reflect it.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety summary lists 46 participants at risk in PS-FO and 45 in control. It reports zero serious adverse events in each group. For other adverse events, it reports one affected participant in each group. These are counts as posted; the registry record does not provide event descriptions in the serious-adverse-event terms list.

The deaths fields are not populated, so deaths are not reported in the registry record. The summary does not provide detailed event types, severity definitions for the other adverse events, timing, or an assessment of whether events were considered related to the interventions. It also does not explain how the safety population relates to the primary analysis population.

These figures are descriptive counts, not a complete safety assessment. With no event-level detail or reported comparative analysis, they should not be used to infer that risks were equivalent between groups or that an intervention caused or prevented an event. The record supports only the limited statement that no serious adverse events are listed and one other adverse event is listed in each group.

16. What the Result Does, and Does Not, Mean

The posted primary result describes a baseline difference in LDL cholesterol, not a measured treatment effect. The mean difference is 1.9 mg/dl, and the interval from -5.949 to 9.749 includes zero. This indicates that the baseline comparison is uncertain and does not establish a clear difference between groups. It also does not establish that the groups were equivalent, since no equivalence margin or equivalence analysis is reported.

The study's stated question concerns whether plant sterols esterified to fish oil fatty acids improve the lipid profile. However, the posted primary and secondary timeframes are at baseline. The registry record does not report a primary analysis of post-intervention LDL cholesterol or change from baseline, so the posted results cannot answer whether the intervention changed LDL cholesterol relative to corn oil. The same limitation applies to interpreting the posted secondary comparisons as intervention effects.

The reported exclusions and differing counts across the primary and safety summaries add uncertainty about which participants contribute to each analysis. The record does not provide a complete participant flow, missing-data approach, or sensitivity analysis that would clarify how these choices affect interpretation. Nor does it report the trial's original statistical plan or sample-size justification.

Accordingly, the result does not establish that the supplement works or does not work, and it does not establish the absence of a potentially meaningful effect. It shows the posted baseline group summaries and their statistical uncertainty. Further conclusions about efficacy, clinical importance, or treatment-period safety would require results and methods not reported in the registry record. The planning calculations are separate hypothetical illustrations and cannot fill that evidence gap.

17. Why This Trial Matters Statistically

This record illustrates why endpoint timing is as important as the numerical estimate. A randomized design is often discussed in terms of comparing interventions, but a posted measurement labeled at baseline describes the groups before the intervention outcome is assessed. Reading the result as an effect would confuse a starting-point comparison with a treatment-period contrast.

It also demonstrates the value of reporting estimates with intervals rather than relying on a p-value alone. The mean difference and its posted interval show both the direction of the estimate and the range of uncertainty. The interval includes zero and spans values on both sides, while the unadjusted p-value does not provide clear evidence of a baseline group difference. This is more informative than treating a single threshold as a verdict, although it still cannot answer the intervention question.

The record further highlights the importance of analysis populations and transparent participant accounting. Enrollment, primary-analysis counts, and safety counts are distinct, and the registry does not reconcile them in detail. The stated exclusions based on weight change and compliance make the path from randomization to analysis consequential. Clear participant flow and analyses that show the effects of population choices would help readers assess robustness.

Finally, the planning table is useful only when its role is kept clear. It illustrates how hypothetical sample-size needs change with the effect targeted under specified assumptions; it is not an account of the trial's original planning and not observed power. The record thus offers several statistical lessons about timing, precision, population definition, and the limits of registry results.

18. 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.

A trial-specific limitation is that the posted primary outcome is labeled at baseline, even though the stated study purpose concerns lipid-profile improvement. The registry record does not report a post-intervention primary estimate or a comparison of change from baseline. As a result, the posted analysis does not directly address the intended treatment question.

The primary analysis description indicates exclusions for body-weight change of more than 3 kg during the interventions or compliance below 65%. The record does not give the number excluded for each reason, their group assignments, or the results of an analysis retaining all randomized participants. This prevents a full assessment of how the restricted analysis population may shape the reported comparison.

Participant counts also differ across the posted summaries: the primary comparison lists 34 and 33 participants, while the safety summaries list 46 and 45 at risk. Enrollment is 91. The registry record does not provide a participant-flow account that reconciles these figures. It is therefore difficult to determine the completeness of each outcome analysis or the reasons for the different denominators.

The secondary outcomes are also labeled at baseline, and CRP is named among secondary outcomes without a corresponding posted result in the secondary comparisons. The record does not report multiplicity handling, missing-data methods, a detailed statistical analysis plan, or sensitivity analyses. Serious adverse-event counts are listed, but event-level descriptions and deaths are not reported in the registry record. These omissions limit interpretation of both outcome robustness and safety completeness.

Finally, the registry does not report the original sample-size justification, the trial's own design assumptions, or interim analyses. The posted planning illustration cannot substitute for those details, because it is based on the observed effect and stated planning assumptions rather than the trial's documented original design.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels — NCT00441480.
• Registry record last updated 2012-01-13; status last verified 2012-01.
• Results first posted 2009-08-14.
• 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.

22. Record Summary

The registry record describes a completed phase 4, randomized, quadruple-masked, parallel-group study of plant sterols esterified to fish oil fatty acids versus corn oil in healthy, hyperlipidemic subjects. Enrollment was 91, and dyslipidemia is listed as the condition.

The primary outcome is LDL cholesterol in mg/dl, summarized as a mean and standard deviation. Its timeframe is at baseline. The posted primary comparison reports 34 participants in PS-FO and 33 in control, a mean difference of 1.9 mg/dl, an interval from -5.949 to 9.749, and an unadjusted p-value of 0.635.

Posted secondary comparisons concern triglycerides, total cholesterol, and HDL cholesterol, also labeled at baseline. The record lists CRP as a secondary outcome but does not post a corresponding result among the listed comparisons. Safety summaries report zero serious adverse events and one other adverse event in each group. The registry does not report a treatment-period primary analysis, the original sample-size justification, or a detailed account of the analysis populations.