Study Design
Single-arm, open-label interventional trial (NCT06325644). 20 ADPKD patients at high risk for rapid progression (Mayo Class 1C-1E). Funded by the U.S. Department of Defense (CDMRP-PR212399-G). Assessments at baseline, 6 months, and 12 months including MRI for kidney volume and GFR.
Intervention
Well-formulated ketogenic diet for 52 weeks targeting blood ketones >0.5 mM (<50g/day carbohydrate, ~1.5 g/kg protein, remainder fat from whole foods). Monitoring includes daily finger-stick ketones (KetoMojo), continuous glucose/ketone monitor (CGM/CKM replaced every 2 weeks), blood draws, DEXA scanning, and MRI.
Context & Comparison
First long-duration (1 year) ketogenic diet trial for ADPKD with continuous ketone monitoring. Unlike the Juntendo trial which uses KetoCitra supplementation, this study tests diet alone without exogenous ketone support.
Significance
Led by Jeff Volek — one of the world's leading ketogenic diet researchers — this DoD-funded trial represents the first U.S.-based, year-long ketogenic intervention in ADPKD. The use of continuous ketone monitoring and MRI-based htTKV measurement will provide the most detailed longitudinal data on ketosis levels and kidney volume change. Primary completion estimated December 2026.