Cukoski · Cell reports. Medicine 2023 · randomized controlled trial · n=66

Feasibility and impact of ketogenic dietary interventions in polycystic kidney disease: KETO-ADPKD-a randomized controlled trial.

Cited 75 times in the scientific literature.

Level 2 - randomized trial

Randomized controlled trial (exploratory three-arm study)

PubMed 37935200 · doi:10.1016/j.xcrm.2023.101283 · record verified 2026-08-29

What was done

An exploratory randomized controlled trial (KETO-ADPKD; NCT04680780) randomized 66 patients with autosomal-dominant polycystic kidney disease (ADPKD) into three arms: a ketogenic diet (KD), water fasting (WF), or a control group. Ketosis was verified by blood and breath acetone. Evaluated outcomes included feasibility, body fat, liver and kidney volumes, renal function, adverse events, and NMR lipid profiles.

What was found

Both KD and WF induced significant ketogenesis. Feasibility was reported by 95% of KD participants and 85% of WF participants. KD resulted in significant reductions in body fat and liver volume, along with a reduction in kidney volume that did not reach statistical significance. Renal function improved in the KD group at the end of treatment, whereas both the control and WF groups showed progressive decline. Safety events were largely mild, transient, and expected (initial flu-like symptoms). Specific numerical effect sizes, confidence intervals, and p-values for organ volumes and kidney function were not reported in the abstract.

Why it matters

This study provides early clinical evidence that dietary ketosis is feasible and may favorably alter kidney function trajectories in ADPKD, translating prior findings from animal models.

Limits

The study is small (66 participants across three arms) and exploratory. Kidney volume reduction did not achieve statistical significance. The abstract omits exact numerical effect sizes, treatment duration, and long-term clinical or renal survival outcomes.

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