FOR IMMEDIATE RELEASE

Interim Clinical Trial Results Show Significant Efficacy of KetoCitra® in Combination With Nutritional Changes in Autosomal-Dominant Polycystic Kidney Disease

SANTA BARBARA, CA – Santa Barbara Nutrients (SBN) is pleased to announce the first interim results from an ongoing clinical trial to study the safety and efficacy of SBN’s medical food KetoCitra® in combination with education on ketogenic nutrition and lifestyle changes in individuals with moderate Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Targeting the Metabolic Vulnerability of ADPKD

This study, led by Dr. Shigeo Horie at Juntendo University in Tokyo, Japan, provides robust evidence that a targeted metabolic approach can successfully modify the disease process. By shifting the body’s primary fuel source from glucose to ketones, the intervention aims to effectively starve glucose-dependent cystic cells. This metabolic shift is supported by supplementation with KetoCitra® to supply the exogenous ketone beta-hydroxybutyrate. Additionally, KetoCitra® supplementation provides citrate and alkaline base to help normalize urinary citrate levels and urinary pH, thereby reducing the risk of calcium oxalate and uric acid microcrystal formation in kidneys. 

Even though this is a one-year, controlled intervention study, after only three months of intervention, the study surprisingly already demonstrated statistically significant interim results:

• Clinically Meaningful Kidney Volume Decline: Subjects in the intervention group experienced a statistically significant 5.01% reduction in Total Kidney Volume (TKV) compared to the control group which showed a TKV increase by 8.03%

• Renal Function Stability: The intervention group showed a trend towards stabilization of eGFR (+0.59 ml/min/1.73 m²), while the control group continued to show a decline (-1.57 ml/min/1.73 m²).

• High Tolerability and Adherence: The study reported a 100% adherence rate, with zero participants discontinuing the program, demonstrating that the educational protocol is feasible and sustainable for patients.

These interim results were recently presented at the annual conference of the American Society of Nephrology (Abstract Here) and separately at the annual conference of the PKD Association of Japan. 

The Combined Impact of KetoCitra® and nutritional changes.

Besides supplementation with KetoCitra, the success of the intervention is driven by a sophisticated educational program. This same program, Ren-Nu™, is already offered by SBN to individuals with ADPKD and uses digital tools to facilitate patient education including self-monitoring of biomarkers and nutrient-tracking, and integrates the use of KetoCitra. The Ren-Nu™ Program, a dietitian-led program, provides the educational and clinical framework for patients to reach a state of nutritional ketosis safely. The program is specifically designed to meet the unique needs of kidney patients, emphasizing low-oxalate intake and renal-safe nutrient ratios. KetoCitra provides exogenous beta-hydroxybutyrate (BHB) to support ketosis and alkaline citrate to balance urine pH. This combination is essential for neutralizing the potential acid load and reducing the lithogenic (stone-forming) risk associated with metabolic shifts.

Expert Commentary

"Seeing a 5% reduction in total kidney volume in just 90 days in this controlled clinical trial matches our experience with participants of our Ren-Nu program and is a major milestone in ADPKD research," said Dr. Thomas Weimbs, CEO of Santa Barbara Nutrients and professor at the University of California Santa Barbara. "By using the Ren-Nu program to change the body's fuel source and KetoCitra to provide the necessary metabolic support, we are providing a non-pharmacological tool to address ADPKD progression directly."

About Santa Barbara Nutrients

Santa Barbara Nutrients is a Public Benefit Corporation dedicated to bringing science-based metabolic therapies to the kidney community. Their flagship products, the Ren-Nu™ program and KetoCitra®, represent the frontier of metabolic nephrology.

For more information, please visit www.SantaBarbaraNutrients.com, Ren-Nu.org or contact info@sbnutrients.com.