Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence (NCT06022094), a na na study. The primary outcome is Change in Blood Glucose Levels.

2. Clinical Question

3. Trial Design

The registry identifies the SAGE Study as an intervention study in a seniors’ residence and lists its model as SINGLE GROUP. Its stated comparison is a before-and-after assessment: data were to be collected before and after the reduced-carbohydrate intervention. Allocation is recorded as NA, and masking as NONE. No separate control group is described, so the design does not provide a concurrent comparison with people who did not receive the reduced-carb menus.

The intervention is named “2 months of reduced carb menus.” The study summary describes the intended assessment as including glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity, and well-being. The primary outcome is change in blood glucose levels, with the timeframe listed as baseline versus 2 months. Enrollment is recorded as 29. The study status is COMPLETED, with a start date of 2023-09-10 and a primary completion date of 2023-12-15.

The registry describes SAGE as phase 2 of the project and says it follows the Ketohome project, phase 1, which assessed feasibility. The registry record does not report the procedures or results of that earlier project, so it cannot establish how its findings relate to SAGE’s outcomes.

Several design details needed to assess execution are not reported in the registry record: eligibility criteria, the residence’s location, recruitment procedures, the number who began or completed the intervention, adherence, and the handling of any departures from the menu. The record also does not describe whether outcome assessors or analysts were blinded. Completion status indicates that the study is recorded as completed; by itself, it does not establish that outcome data or statistical results are available.

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

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 Change in Blood Glucose Levels, measured over Baseline versus 2 months.

The primary endpoint is change in blood glucose levels, with the registry listing the unit as mmol/L, the parameter as MEAN, and the dispersion measure as Standard Deviation. The stated timeframe is baseline versus 2 months. The registry description says glucose would be monitored continuously using a real-time continuous glucose monitor (CGM) for two 10-days periods: before and after the intervention.

Continuous monitoring can characterize glucose across the monitoring periods rather than relying only on a single measurement at one moment. In general, summarizing a continuous measure with a mean describes its average level over the period represented, while the standard deviation describes variation around that mean. Those summaries do not, on their own, explain the pattern of readings over time or whether differences are meaningful for participants.

The registry record does not specify the exact method used to derive the endpoint from the CGM readings, such as which readings were included or how the before-and-after periods were summarized. It also does not report the observed mean, standard deviation, change estimate, confidence interval, or statistical test. The outcome’s purpose is to assess whether blood glucose levels differed between the baseline and post-intervention monitoring periods; the posted information does not show what that comparison found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry gives an outcome definition and a broad before-and-after design, but it does not report the statistical analysis used. The following points explain the concepts relevant to interpreting this kind of study in general; they should not be read as a description of analyses actually performed for SAGE.

What does a before-and-after comparison estimate?

In general, a before-and-after analysis compares measurements made in the same study group at two time points. When the same participants contribute measurements at both times, the observations are related rather than independent. A paired analysis accounts for this relationship by focusing on within-participant changes. The registry says data would be collected before and after the intervention, but it does not report whether the same participants contributed usable measurements at both times, how changes were calculated, or what statistical method was used.

A before-and-after estimate describes change across the observed periods. It does not, by itself, identify the cause of that change. Without a concurrent control group, changes in participants’ circumstances or other factors over time may also contribute. This limitation concerns causal interpretation; it is distinct from whether a statistical test detects a difference.

What do the mean and standard deviation describe?

For a continuous outcome, the mean is a measure of average level. The standard deviation describes how spread out measurements are around the mean. The registry specifies the mean and standard deviation for the blood glucose outcome, but gives no values. These summaries are not interchangeable: a mean can describe the center of a distribution while concealing variation or patterns that may matter for interpreting repeated CGM readings.

In general, continuous glucose monitoring produces measurements across time. Analysis choices can affect how those readings are represented, including how readings are summarized within a monitoring period and how the before-and-after summaries are compared. The exact derivation of the registered endpoint is not reported in the registry record. The stated monitoring plan is two 10-days periods, one before and one after the intervention.

How should uncertainty be assessed?

A confidence interval is a statistical range used to express uncertainty around an estimate under a particular model and its assumptions. It helps readers assess which values are reasonably compatible with the data and how precisely the change has been estimated. A point estimate alone does not convey that uncertainty. Neither a point estimate nor a confidence interval for the primary outcome is reported in the registry record.

A p-value is calculated relative to a null hypothesis and a statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of a difference. The registry record reports zero analyses and no p-values. It does not state whether a hypothesis test was planned, which model would be used, or whether estimates would be adjusted for other variables.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model assumes. If a model understates variability, standard errors and confidence intervals can be too small, and tests can appear more decisive than the data warrant. This issue is especially relevant to some count or event models. The registered primary endpoint is continuous, with a mean and standard deviation specified; the record does not report an analysis model or evidence of over-dispersion. It would therefore be inappropriate to claim that over-dispersion was assessed or affected the SAGE analysis.

What do the planning assumptions mean?

The registry’s sample-size description identifies a planning illustration, not the study’s own design justification. It specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of an observed effect. For outcomes other than time-to-event outcomes, the described planning quantities are participants per arm for 80% power or other stated power levels. These are planning concepts, not observed results, and cannot be interpreted as observed power.

Those assumptions describe a two-arm planning setup, whereas SAGE is registered as a single-group study with a before-and-after comparison. The registry does not report a protocol-based sample-size justification or explain how the planning illustration relates to the registered design. Because the observed effect and the numerical planning outputs are not reported in the registry record, no particular planning requirement can be inferred from the description.

Overall, the record supports a description of the endpoint and intended time comparison, but not a reconstruction of the statistical analysis. The analysis population, missing-data method, model, handling of repeated measurements, adjustment strategy, and uncertainty estimates are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Delta of Before/After the Intervention")
n   <- c(24)
m   <- c(-0.1)
sp  <- c(0.2)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Delta of Before/After the Intervention  24  -0.100  0.200  -0.184  -0.016

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures. It identifies change in blood glucose levels as the primary outcome and lists secondary outcomes for blood triglycerides, blood cholesterol, and blood glycated hemoglobin. The names and definitions of the other outcome measures are not reported in the registry record. The record does not state which outcomes were formally tested, how outcomes were prioritized beyond the primary designation, or whether any adjustment for multiple comparisons was planned or performed.

In general, when several outcomes or statistical tests are examined, the chance of finding at least one apparently unusual result can increase. Multiplicity methods can address that issue, but the appropriate approach depends on the study questions and analysis plan. No multiplicity adjustment or prespecified testing hierarchy is reported. Since no analysis results are reported, the extent to which multiple testing affected interpretation cannot be assessed.

Missing-data procedures are also not reported. The record does not state how incomplete CGM periods, missing readings, withdrawals, or other unavailable measurements were handled. It does not report the number of participants with baseline and post-intervention data or the analysis population for any endpoint. The enrollment figure of 29 cannot establish how many participants contributed to an analysis.

In general, missing measurements can affect both the precision and the interpretation of an estimate, particularly if data availability is related to participants’ outcomes or experience. Methods such as complete-case analysis or imputation require assumptions, and those assumptions should be stated and assessed. The registry does not identify a method or report sensitivity analyses. The planned analysis population and the handling of missing outcome data are therefore not reported in the registry record.

12. 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’s adverse-event entry lists 24 at risk for serious adverse events and 0 affected. It also lists 24 at risk for other adverse events and 0 affected, with 0 deaths. These are the safety figures recorded for the group titled “Delta of Before/After the Intervention.” The record does not describe the event terms, and no serious-event terms are listed.

A count of 0 affected means that the registry entry records no affected participants for the listed categories. It does not establish that every possible adverse event was actively sought, that no events occurred outside the recorded definitions or observation period, or that the intervention is free of risk. The safety observation timeframe, event-collection procedures, severity definitions, and relationship assessment are not reported in the registry record.

The figures should also be read in context: the registry records enrollment of 29, while the safety entry lists 24 at risk. The record does not explain the difference or report the reasons any enrolled participants were not included in the risk figures. No inference about those participants’ safety status is warranted. These entries describe what the registry records, not a complete account of safety monitoring or comparative safety.

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

The record establishes that the SAGE study was registered as a completed, single-group intervention study of 2 months of reduced-carb menus in a seniors’ residence. Its primary question concerns change in blood glucose levels from baseline to 2 months, measured with continuous glucose monitoring during two 10-days periods. It also lists secondary blood biomarker outcomes and describes broader interests including cognition, quality of life, physical activity, and well-being.

The record does not report the primary glucose result or any analysis results. It therefore does not establish whether glucose levels increased, decreased, or remained similar; how large any change was; or how precisely it was estimated. No conclusion about the direction or magnitude of change can be drawn from the registered outcome definition alone. Completion status is information about study status, not evidence of a particular outcome.

Even if a before-and-after difference were available, this design would not include a concurrent control group according to the registry record. A change over time could not automatically be attributed to the menu. General factors that vary over time may influence measurements, and the record does not report information that would allow their contribution to be separated from any intervention-associated change.

The safety entry records zero affected participants in the serious and other adverse-event categories, with 24 listed at risk in each category and zero deaths. These figures are limited to the registry entries and do not establish the completeness of event monitoring or the absence of unrecorded events.

Accordingly, the registry provides useful information about the research question, design, and planned measurements, but not enough outcome evidence to judge the observed glucose response, its statistical precision, or its clinical relevance. The effect of the intervention, adherence, missing data, and analysis methods are not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of how a clear outcome question and a design’s limitations need to be considered together. The primary endpoint is defined as a before-and-after change in blood glucose, with continuous monitoring in a seniors’ residence. The record also makes the single-group structure explicit. That distinction matters because a within-group change and a randomized comparison answer different questions: the former describes change over time, while a controlled comparison can better distinguish intervention-associated differences from other time-related changes.

The registry also highlights why outcome definitions are not a substitute for outcome results. Specifying a continuous measure, unit, summary parameter, dispersion measure, and timeframe helps readers understand what investigators intended to measure. But without the estimate and its uncertainty, readers cannot assess the direction, size, or precision of the change. A completed status does not fill that gap.

Several details important to statistical interpretation are absent: the analysis population, endpoint derivation from CGM data, missing-data procedures, inferential model, multiplicity plan, and results. These are not merely technical details. They determine what the estimate represents, how uncertainty is quantified, and which conclusions are supported.

The planning assumptions also deserve careful separation from the registered design. The described illustrations assume equal allocation between two arms and a normal approximation, while the study is registered as a single-group before-and-after intervention. Planning outputs cannot be treated as observed results or as evidence of observed power. Their presence does not establish a design justification for SAGE.

For readers assessing clinical research, the key lesson is to distinguish the stated question, the design used to address it, and the evidence actually reported. In this record, the question and design are described, but the outcome estimates and analysis needed to evaluate the answer are not reported in the registry record.

15. 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 central limitation for interpretation is that the registry record does not report results for the primary endpoint. Without a glucose change estimate, its standard deviation, or an uncertainty interval, the observed response and its precision cannot be assessed. The record also reports zero analyses, so no inferential result is available in the registered information.

The single-group before-and-after design has no concurrent control group described. In general, this means that a change between baseline and follow-up cannot by itself separate an intervention-associated effect from other changes over time. The record does not report measures that would allow those possible influences to be evaluated.

The endpoint uses continuous glucose monitoring in two 10-days periods, but the registry does not explain how readings were processed or how the primary outcome was derived. It does not report whether the same participants contributed to both monitoring periods, the number with usable readings, adherence to monitoring, or how incomplete monitoring data were handled. These omissions limit assessment of the endpoint’s construction and representativeness.

Enrollment is listed as 29, while the safety entry lists 24 at risk; the registry does not explain the distinction. Participant characteristics, eligibility criteria, recruitment details, intervention adherence, and the analysis population are not reported. Generalizability beyond the people studied in this residence therefore cannot be assessed from the record.

Finally, the statistical plan is not described. The registry does not report methods for repeated measurements, missing data, multiplicity, covariate adjustment, or sensitivity analyses. The names of all six outcome measures are not available in the record, and no results are listed for the named secondary outcomes. These gaps prevent a comprehensive assessment of both the primary endpoint and the broader study objectives.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence — NCT06022094.
• Registry record last updated 2026-10-28; status last verified 2024-08.
• Results first posted 2026-10-28.
• 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.

19. Record Summary

NCT06022094, titled “Effect of a Two-month Carbohydrate-restricted Diet on Energy Metabolism in a Seniors' Residence,” is recorded as COMPLETED. The sponsor is Université de Sherbrooke. The study start date is 2023-09-10, and the primary completion date is 2023-12-15. The registry lists enrollment of 29, condition Healthy Aging, phase NA, allocation NA, masking NONE, and model SINGLE GROUP.

The intervention is named 2 months of reduced carb menus. The primary outcome is change in blood glucose levels, measured in mmol/L, with a mean and standard deviation specified and a timeframe of baseline versus 2 months. The description refers to continuous glucose monitoring for two 10-days periods before and after the intervention. Secondary outcomes listed are changes in blood triglycerides, cholesterol, and glycated hemoglobin.

The registry lists six outcome measures and zero analyses. It does not report glucose results, analysis methods, missing-data handling, or the full set of outcome names. Its safety entry records 24 at risk and 0 affected for serious adverse events, 24 at risk and 0 affected for other adverse events, and 0 deaths.