Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults (NCT03413735), a randomized na study. The primary outcome is Endotoxin.

2. Clinical Question

3. Trial Design

The registry describes a randomized, triple-masked, parallel study with an enrollment of 40. Its status is completed. The listed phase is NA, so a formal trial phase is not reported in the registry record. Ohio State University is named as sponsor. The record lists a start date of 2018-08-29 and a primary completion date of 2019-07-30.

The study summary describes two phases. Phase I was a pharmacokinetic study of green tea catechin bioavailability after a single dose of a green-tea-extract-containing confection in lean and obese persons. The summary then describes Phase 2 as a randomized parallel comparison of placebo and green tea extract confections among lean and obese persons. The arm descriptions specify daily consumption for 4 weeks. The registry does not provide enough detail to establish how participants moved between phases, how the randomized sample was recruited, or whether every participant in the first phase entered the second.

Four outcome groups are posted: Lean - GTE, Obese - GTE, Lean - Placebo, and Obese - Placebo, each with 10 participants for the primary endpoint. This layout permits comparisons across both treatment assignment and body-size category, but the posted comparisons use Lean - Placebo as the reference group. A direct green-tea-versus-placebo estimate within the obese category is not listed, nor is a direct comparison within the lean category listed as a separate contrast.

The registry record does not report the randomization procedure, the details of triple masking, allocation concealment, eligibility criteria, or the original design assumptions. It also does not report whether the two phases were analyzed jointly or separately. Those details matter for understanding how the study was conducted, but they cannot be inferred from the arm labels or the posted summary statistics.

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: In Phase 1, participants were stratified by phenotype (lean vs. obese) and received a single dose of a green tea extract (GTE)-enriched confection. This phase was conducted to evaluate catechin bioavailability. All participants consumed the same GTE confection. After a washout period, participants were randomized in Phase 2 to receive either a GTE or placebo confection daily for 4 weeks in a double-blind trial.

Pharmacokinetic Study

Randomized Controlled Trial

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 Endotoxin, measured over Week 0 - Fasting.

The primary endpoint is serum endotoxin concentration, measured in EU/mL. Endotoxin is relevant to the study’s stated focus on metabolic endotoxemia: the study summary proposes that gut barrier function may influence endotoxin translocation and associated low-grade inflammation. In general, a biomarker endpoint provides a measurable biological outcome that can be compared across study groups. The endpoint itself does not establish why a measured value is higher or lower, or whether any difference is clinically important.

The recorded timeframe is Week 0 - Fasting. This means the posted primary values describe fasting measurements at Week 0, with the registry reporting a mean and standard deviation for each group. These are baseline values, not a reported measurement after the daily confection period. Consequently, the primary results do not directly quantify change during the 4-week intervention or an intervention effect at follow-up.

At Week 0, the reported means are 14.44 for Lean - GTE, 12.97 for Obese - GTE, 12.25 for Lean - Placebo, and 17.65 for Obese - Placebo. The corresponding standard deviations are 4.46, 6.44, 6.05, and 12.58. Each group has 10 participants. The registry does not report a separate clinical threshold for interpreting endotoxin concentrations, or a statement of what difference would be important to participants. Those interpretive benchmarks are not reported in the registry record.

7. Results Posted in the Registry

• Lean - GTE: mean 14.44 versus 12.25 on control; difference 2.19 (95% CI -2.47 to 6.85), standardized effect d = 0.41; z-test p = 0.357.
• Obese - GTE: mean 12.97 versus 12.25 on control; difference 0.72 (95% CI -4.76 to 6.20), standardized effect d = 0.12; z-test p = 0.797.
• Obese - Placebo: mean 17.65 versus 12.25 on control; difference 5.40 (95% CI -3.25 to 14.05), standardized effect d = 0.55; z-test p = 0.221.

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.

Gut Permeability - Lactulose to Mannitol Ratio

• 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:
  • Lean - GTE: mean 0.12 versus 0.10 on control; difference 0.02 (95% CI -0.03 to 0.07), standardized effect d = 0.36; z-test p = 0.418.
  • Obese - GTE: mean 0.09 versus 0.10 on control; difference -0.01 (95% CI -0.05 to 0.03), standardized effect d = -0.24; z-test p = 0.588.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lean - GTE and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Obese - GTE and the control. The interval gives the range of effects that remain compatible with the data.

Gut Permeability - Sucralose to Erythritol Ratio

• 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:
  • Lean - GTE: mean 0.02 versus 0.02 on control; difference 0.00 (95% CI -0.01 to 0.01), standardized effect d = 0.00; z-test p = 1.000.
  • Obese - GTE: mean 0.02 versus 0.02 on control; difference 0.00 (95% CI -0.01 to 0.01), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lean - GTE and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Obese - GTE and the control. The interval gives the range of effects that remain compatible with the data.

Urinary Sucralose/Erythritol Ratio (mg/mg)

• 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:
  • Lean - GTE: mean 0.01 versus 0.02 on control; difference -0.01 (95% CI -0.02 to -0.00), standardized effect d = -1.00; z-test p = 0.025.
  • Obese - GTE: mean 0.01 versus 0.02 on control; difference -0.01 (95% CI -0.02 to -0.00), standardized effect d = -1.00; z-test p = 0.025.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Lean - GTE than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Obese - GTE than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcomes cover measures of gut permeability, including lactulose-to-mannitol and sucralose-to-erythritol ratios. The recorded timeframes include Week 0 measurements and a Week 4 urinary sucralose/erythritol ratio. Across the posted results, the pattern is not uniform: some group summaries are similar, while some recalculated contrasts differ from zero. The secondary outcome listings include repeated instances of the lactulose-to-mannitol and sucralose-to-erythritol outcome names, and the record lists 27 outcome measures overall while 24 secondary outcomes are posted.

These outcomes provide related biological context for the study’s proposed gut-barrier rationale, but they are not substitutes for the primary endpoint. The primary result is a Week 0 fasting endotoxin measurement, and the secondary results include measures at different time points. A result from one outcome or timeframe cannot establish a change in another. The registry does not report a joint analysis linking changes in permeability measures with changes in endotoxin, nor does it post a reported analysis of association between these outcomes.

Unadjusted secondary comparisons carry less weight because many outcomes and contrasts create many opportunities for chance findings. In general, when many statistical tests are conducted, some may appear notable even if there is no underlying effect. A multiplicity procedure can address this issue, but a correction or hierarchy for testing is not reported in the registry record. This means nominal p-values from individual secondary comparisons should be treated as exploratory rather than as a coherent set of confirmatory findings.

The registry lists no reported analyses for the posted secondary outcomes. The available pairwise estimates are simple unadjusted recalculations from summary statistics. The record does not explain whether all measured outcomes were prespecified, how missing measurements were handled, or how the study intended to interpret the collection of secondary measures. Accordingly, the overall secondary pattern can inform what was measured and where additional uncertainty remains, but it does not resolve the limitations of the primary result or establish an intervention effect.

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

• Gut Permeability - Lactulose to Mannitol Ratio
• Gut Permeability - Lactulose to Mannitol Ratio
• Gut Permeability - Lactulose to Mannitol Ratio
• Gut Permeability - Lactulose to Mannitol Ratio
• Gut Permeability - Sucralose to Erythritol Ratio
• Gut Permeability - Sucralose to Erythritol Ratio
• Urinary Sucralose/Erythritol Ratio (mg/mg)
• Gut Permeability - Sucralose to Erythritol Ratio

9. Statistical Interpretation

10. Statistical Methods Explained

The registry identifies the primary outcome as a continuous measure summarized by its mean and standard deviation. In general, a mean describes the arithmetic center of the observations in a group, while a standard deviation describes how spread out individual observations are around that mean. Neither summary alone shows the full distribution of the measurements. The groups each have 10 participants for the primary outcome, so the group summaries rest on a small number of observations.

What does a mean difference describe?

A mean difference expresses the difference between two group means in the outcome’s measurement units. For the posted primary comparisons, Lean - Placebo is the reference group. The comparison estimate is therefore a contrast with that group, not a direct green-tea-versus-placebo contrast within the same body-size category. For example, the obese green tea extract group is compared with Lean - Placebo in the posted contrast; it is not compared with Obese - Placebo. A difference between those two obese groups is not reported as a comparison.

In general, selecting a reference group determines which specific question a contrast answers. The posted estimates can be read as descriptions of each listed group relative to Lean - Placebo, but they do not answer every potentially relevant comparison among the four groups. A two-by-two arrangement of treatment and body-size categories does not by itself imply that a treatment-by-category interaction was estimated. Such an interaction result is not reported in the registry record.

How should a confidence interval be understood?

In general, a confidence interval represents the uncertainty around an estimated quantity under the assumptions of the method used to calculate it. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. For a mean difference, zero represents no difference in the population contrast. An interval spanning zero leaves a range of plausible values that includes no difference and values on both sides of it. The confidence-interval level and the method used to calculate the intervals are not reported in the registry record, so the interval construction cannot be fully assessed from the posted information.

What do the p-values say?

In general, a p-value measures how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the statistical model were true. It does not measure the probability that the null hypothesis is true, the size of an effect, or the chance that a result will replicate. The listed p-values are unadjusted. They address each comparison without a reported adjustment for the number of outcomes or contrasts. No sponsor-reported statistical analyses are listed for the posted outcomes, and the registry does not report the planned model, testing procedure, or analysis population.

The reported comparisons are recalculated, simple unadjusted comparisons based on posted group summary statistics. This kind of reconstruction can help readers see the size and uncertainty of a contrast, but it does not account for unreported covariate adjustment, repeated measures, or other modeling decisions. None of those methods can be attributed to the investigators based on this record. The registry also does not report the method used to handle missing observations or the assumptions made about them.

Why does variation matter?

In general, greater variability within groups makes a mean difference harder to estimate precisely when the group sizes remain the same. Standard deviations can therefore help readers understand why a point estimate may have a broad confidence interval. The primary group standard deviations range from 4.46 to 12.58. In particular, the Obese - Placebo group has a standard deviation of 12.58, compared with its mean of 17.65. With only 10 participants in that group, estimates of its mean and contrasts involving it may be sensitive to individual observations. Individual-level data and distribution plots are not reported in the registry record, so the influence of individual values cannot be assessed.

In general, over-dispersion means that observed variation is greater than a statistical model expects. When present, it can make standard errors too small and intervals too narrow if the analysis fails to accommodate it. The registry does not report an over-dispersion assessment or a model for these continuous outcomes. This concept is relevant as a general consideration, not a claim that over-dispersion was present in this trial.

Finally, the timing of a measure is part of its statistical meaning. The primary endpoint is explicitly a fasting Week 0 measurement. It cannot be treated as a post-intervention result merely because the study was designed around a 4-week confection period. A baseline comparison may describe initial group balance, but it does not estimate the change that occurred during follow-up. The registry record does not report a post-intervention primary endotoxin analysis or a baseline-adjusted estimate.

11. Confidence Intervals and Precision

The primary mean-difference intervals are broad. For Lean - GTE compared with Lean - Placebo, the estimated difference is 2.19 and the confidence interval runs from -2.469 to 6.849. For Obese - GTE compared with Lean - Placebo, the estimate is 0.72 and the interval runs from -4.757 to 6.197. For Obese - Placebo compared with Lean - Placebo, the estimate is 5.4 and the interval runs from -3.252 to 14.05. All three intervals include zero, so the posted estimates do not pin down the direction of the corresponding population differences.

In general, an interval gives a range of values compatible with the observed data under the method’s assumptions; its width is a measure of precision, not a direct measure of importance. These intervals span values below and above zero, and their endpoints extend substantially from the estimates. This leaves considerable uncertainty about the size and direction of the group contrasts. The confidence-interval level and calculation method are not reported in the registry record, which limits assessment of how the intervals were constructed.

The small group sizes are important context for precision: each primary group contains 10 participants. Standard deviations also differ across groups, from 4.46 in Lean - GTE to 12.58 in Obese - Placebo. In general, a small sample and variable measurements can make an estimate imprecise. The posted summaries do not show individual values, and the registry does not report a model that could clarify how variation was handled.

These intervals concern the posted Week 0 contrasts. They do not quantify uncertainty in a 4-week treatment effect, because no post-intervention primary result or change estimate is listed. The intervals should therefore be interpreted as uncertainty around the baseline group comparisons, not as an estimate of the possible effect of green tea extract after consumption.

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 planning figures are illustrative calculations based on observed effects, not the trial’s original design. They assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The figures give participants per arm for the continuous outcomes. They are not total event counts. The original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the calculated participants per arm for a planning scenario intended to have an 80% chance of detecting the specified effect under the stated assumptions, if that effect and the model assumptions are correct. The 90% column uses a higher target chance of detecting that effect, and therefore generally calls for more participants per arm. These are planning concepts; they are not guarantees about what a future study will find.

Rows using 100% of the observed effect use the full effect estimate from the posted comparison as the planning target. Rows using 75% or 50% of the observed effect use smaller target effects. Smaller effects are harder to distinguish from random variation, so they require more participants per arm under the same assumptions. The resulting counts can become large, especially when the observed contrast is small relative to variability. For example, the obese green tea extract comparison for primary endotoxin corresponds to 1,183 participants per arm for 80% power when planning for 100% of the observed effect. This is a calculation tied to that observed estimate, not a recommendation for the original trial.

These figures are not observed power. They do not tell how likely the completed study was to detect an effect after its results were known. The registry does not report that these calculations were used to design or enroll the study. They are planning illustrations only, and their meaning depends on the effect target and assumptions stated above.

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 = 2.190; pooled standard deviation σ = 5.315.
2. n = 2 × (1.96 + 0.842)² × 5.315² / 2.190² = 92.5, rounded up to 93 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 <- 2.19                      # observed difference in means
sigma <- 5.31479538646597                     # 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(3413735)
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 = 93 (80% power), 124 (90% power)
 75% of observed effect: n per arm = 165 (80% power), 221 (90% power)
 50% of observed effect: n per arm = 370 (80% power), 496 (90% power)
power.t.test: 93.4 
Simulated power at n = 93 per arm: 0.799 (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 registry record lists multiple secondary outcome measures, repeated outcome names, and several comparisons. It reports 27 outcome measures overall and 24 posted secondary outcomes. No sponsor-reported analyses are listed for the posted secondary outcomes, and the record does not describe a testing hierarchy, multiplicity adjustment, or a prespecified distinction between confirmatory and exploratory analyses. These details are not reported in the registry record.

In general, multiplicity arises when researchers make several statistical comparisons. Each test can produce an apparently unusual result by chance, and the chance of encountering at least one such result tends to grow as the number of tests increases. An adjustment or a prespecified outcome hierarchy can help control how the collection of tests is interpreted. Without a reported approach, an unadjusted p-value should be read as a result for one comparison, not as proof that an overall pattern is unlikely to be due to chance. This is especially relevant when secondary outcomes cover related measurements at multiple time points.

The registry does not report the trial’s original statistical analysis plan, the planned analysis populations, or whether the primary analysis followed intention-to-treat principles. It does not state how participants with incomplete measurements were handled, whether missingness was assessed, or whether imputation was used. These omissions make it difficult to judge whether the reported group summaries represent all randomized participants or only those with recorded outcome data.

The primary groups each have 10 participants in the posted endpoint. One posted secondary comparison uses an Obese - Placebo group of 9, while other groups in that outcome have 10. The registry does not explain the difference in available counts. It also does not report the reason for any missing observation, participant flow by phase, or whether the same participants contributed to every endpoint. These registry entries prevent assessment of the potential impact of missing data on the secondary results.

The registry’s record of randomization and masking provides important design descriptors, but the procedural details and analysis decisions needed to evaluate the resulting statistical tests are not reported. Interpretation should therefore distinguish the descriptive summaries from an unreported planned inferential analysis.

15. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists serious adverse events and other adverse events by group. For serious adverse events, the number affected is 0 in each posted group. The numbers at risk are 10 for Lean - Placebo, 9 for Obese - Placebo, 10 for Lean - GTE, and 10 for Obese - GTE. The record lists 0 deaths in every group. It also lists 0 other adverse events in each group, with the same at-risk counts shown for other events.

These figures describe the events recorded in the registry for the groups and periods represented by the safety results. A count of zero means no event of that category was recorded among the listed participants at risk; it does not establish that an event could never occur or that the groups have identical safety profiles. With small group counts, the absence of a recorded event provides limited information about uncommon events.

The registry does not provide detailed adverse-event terms, event timing, exposure-adjusted rates, or a description of how events were collected. No serious adverse-event terms are listed. The figures should therefore be read as a concise record of reported counts, not as a complete account of safety or as a comparison designed to establish differences between groups.

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

The registry documents a completed randomized, triple-masked, parallel study of green tea extract and placebo confections in lean and obese adults. It describes daily confection consumption for 4 weeks and identifies endotoxin as the primary outcome. The posted primary values, however, are fasting Week 0 measurements. They describe baseline group means and their variability, not the outcome after the intervention period.

The baseline comparisons use Lean - Placebo as the reference. Their confidence intervals are broad and include zero, leaving uncertainty about the direction and magnitude of those group differences. The posted data therefore do not provide a precise estimate of baseline contrasts. They also do not establish a treatment effect, because a post-intervention primary comparison or change-from-baseline estimate is not reported.

The study summary gives a biological rationale involving gut permeability, endotoxin translocation, and inflammation. Related permeability outcomes are posted, including measures recorded at Week 0 and a urinary ratio recorded at Week 4. Those measures may be relevant to the stated research question, but the registry does not report a joint analysis connecting them with the primary outcome. Individual secondary findings should also be interpreted cautiously because there are multiple outcomes and comparisons, and no multiplicity approach is reported.

In general, a randomized comparison is designed to support causal interpretation when the outcome, timing, analysis, and follow-up data align with the treatment question. Here, the posted primary endpoint’s timing does not capture the stated 4-week intervention effect, and the registry does not report the original analysis plan or the post-intervention primary results. As a result, the posted statistics can describe the recorded measurements but cannot determine whether the intervention changed endotoxin or gut permeability.

The record also does not report clinical thresholds for endotoxin, the importance of a particular difference, or the statistical assumptions used in the sponsor’s original analysis. The appropriate reading is consequently limited: these data offer descriptive baseline information and uncertain unadjusted contrasts, while leaving the central post-intervention question unanswered in the registry record.

17. Why This Trial Matters Statistically

This trial illustrates why endpoint timing is as important as the endpoint name. A study may be framed around a 4-week intervention, but a primary outcome recorded at Week 0 describes the groups before that period, not the effect of consuming the intervention. Readers need to check the measurement timeframe before interpreting a mean difference as a treatment result.

It also illustrates how comparison choice shapes interpretation. The posted primary contrasts use Lean - Placebo as the common reference, while the study’s arms include both lean and obese participants assigned to green tea extract or placebo. Those contrasts do not directly estimate green tea extract versus placebo within either body-size category. A design’s group labels alone do not guarantee that the posted analysis answers every clinically or biologically relevant contrast.

The small group sizes and broad confidence intervals show why point estimates should not be read in isolation. An estimate can look substantial or small while remaining imprecise. Confidence intervals communicate a range of uncertainty, and the variability in the reported group summaries helps explain why a small study may not tightly estimate group differences.

Finally, the registry contains multiple secondary outcomes, but does not report a multiplicity strategy or sponsor-reported analyses. This makes it important to distinguish descriptive or unadjusted findings from evidence that was planned and tested as confirmatory. Statistical interpretation depends not only on calculations, but also on the question defined in advance, the chosen comparisons, the timing of measurement, and transparent reporting of missing data and analysis decisions.

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.

The most consequential trial-specific limitation in the posted results is that the primary endpoint is measured at Week 0 - Fasting. The intervention descriptions specify daily consumption for 4 weeks, but no post-intervention primary endotoxin result or change estimate is posted. This prevents the primary result from directly answering whether endotoxin changed over the intervention period.

The primary outcome groups each contain 10 participants. Such small groups limit the amount of information available for estimating means and differences, particularly where the standard deviations are large. The Obese - Placebo standard deviation is 12.58. Individual participant data are not reported, so the effect of unusually high or low measurements cannot be assessed.

The comparison set uses Lean - Placebo as the reference for the posted primary contrasts. Direct green-tea-versus-placebo contrasts within lean participants and within obese participants are not listed. No interaction estimate is reported for whether the treatment contrast differs by body-size category. The posted comparisons therefore do not fully resolve the treatment questions implied by the four-arm arrangement.

The record lists 24 secondary outcomes and 27 outcome measures overall, with repeated outcome labels. No multiplicity adjustment or analysis hierarchy is reported, and no sponsor-reported statistical analyses are listed for the posted secondary outcomes. One secondary comparison has 9 participants in the Obese - Placebo group, but the reason for that count is not reported. The record also does not report missing-data methods, analysis populations, or participant flow through the two phases.

Other information needed to assess generalizability and analytic choices, including detailed eligibility criteria, randomization procedures, masking procedures, confidence-interval methods, and original sample-size justification, is not reported in the registry record. These gaps do not change the posted values, but they limit how fully the study’s execution and inference can be evaluated.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults — NCT03413735.
• Registry record last updated 2025-06-13; status last verified 2025-05.
• Results first posted 2025-06-13.
• 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 describes a completed randomized, triple-masked, parallel study sponsored by Ohio State University, with an enrollment of 40 and a listed phase of NA. The study summary describes pharmacokinetic and randomized parallel phases. The intervention was a green tea extract confection consumed daily for 4 weeks; the comparator was a confection without green tea extract.

The primary outcome is fasting serum endotoxin concentration at Week 0, reported as group means and standard deviations. Each of the four primary groups has 10 participants. The posted unadjusted comparisons use Lean - Placebo as the reference, and their confidence intervals include zero. Because the primary measurement is at Week 0, it does not report a post-intervention treatment effect.

Secondary permeability outcomes include measures at Week 0 and a urinary ratio at Week 4. The record does not list sponsor-reported analyses, a multiplicity approach, missing-data methods, or the original design assumptions. Serious adverse events, other adverse events, and deaths are listed as 0 across the posted groups. The results are best read as limited descriptive evidence, with substantial uncertainty and important post-intervention questions not reported in the registry record.