Study Design
Post-hoc analysis of the KETO-ADPKD randomized controlled trial data (66 patients, 3 months). Focused on patients who achieved sustained ketosis and analyzed TKV changes with refined methodology.
Intervention
Same as KETO-ADPKD: ketogenic diet (<30g carbs/day) for 3 months vs. standard diet control.
Key Results
TKV: Significant decrease
When analyzed with refined methodology and focus on ketosis-adherent participants, the kidney volume reduction reached statistical significance — upgrading the original trial's 'trend' finding.
Context & Comparison
The original KETO-ADPKD trial reported a non-significant trend (-0.55% KD vs +0.79% control). This post-hoc analysis with improved statistical methodology demonstrates the reduction was indeed significant in adherent participants.
Significance
This re-analysis resolves the key limitation of the original KETO-ADPKD trial. The original 3-month period was considered too short to detect TKV changes, but refined analysis shows the effect was present and statistically significant. Combined with the Juntendo 12-month data showing even larger effects, this strengthens the evidence that ketogenic interventions directly reduce kidney volume.