Daily Caloric Restriction in Overweight and Obese Adults with ADPKD: Rationale and Protocol of a Randomized Controlled Trial

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In animal models of autosomal dominant polycystic kidney disease (ADPKD), eating fewer calories slows cyst growth, and early human studies suggested that weight loss might also help slow kidney enlargement in adults with overweight or obesity. This paper describes the design and baseline participants of a 24-month Phase 2 randomized controlled trial (NCT04907799) comparing a behavioral daily caloric restriction weight-loss program with standard dietary advice in 120 adults with ADPKD and overweight or obesity. The primary outcome is the change in height-adjusted total kidney volume on MRI over 24 months. This publication reports only the trial protocol and baseline characteristics; final results are expected after the cohort completes follow-up in July 2027.