Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

Официальное название

Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease

Обзор

This is a 16 week pilot study of the impact of a nutritionist led ketogenic diet (Ren-Nu) supplemented with the medical food KetoCitra on autosomal dominant polycystic kidney disease.

Подробное описание

The goal of the Ren-Nu program aims to improve the metabolic health of ADPKD patients by implementing a plant-focused, kidney-safe, ketogenic diet supported by medical food KetoCitra®. It is a dietitian-led, online group program focused on ketogenic metabolic therapy with rolling recruitment .

For 12 weeks, participants will be remotely directed through the Ren-Nu program by an experienced renal dietitian where they will learn to implement diet and lifestyle changes by completing weekly web-based classes on nutrition principles and food preparation. A continuous glucose monitor (CGM) will be provided for use during the study. Additionally, they will use a smartphone application to track nutrient intake, self-monitor biomarkers, implement mindfulness practice, and participate in facilitated discussions to build community support. Each participant will meet remotely with the renal dietitian and complete laboratory safety monitoring throughout the program to tailor dietary recommendations for optimal compliance. The study will involve visits to the research institution, histories, physical examinations and laboratory work.

Вмешательства

• Пищевая добавка Ren-Nu and KetoCitra
  This is a structured, nutritionist monitored program supplemented with a nutritional food product, while monitoring metabolic parameters

Первичные конечные точки

• Change in Serum Renal Function [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Serum Hepatic Function Biomarkers [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Glycemic Control [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Systemic Inflammation Markers [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Serum Measures of Lipids [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in 24-Hour Urine Collection to track Lithogenic Risk [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Glycemic Variability via a Continuous Glucose Monitor (CGM) [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Anthropometric Measures [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Blood Pressure [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in Serum Fatty Acid [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]

Вторичные конечные точки (5)

• Change in health-related quality of life as assessed by the Quality of Life: Short-Form Health Survey 12 (SF-12v2) [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Change in self reported mental and physical health outcomes [Срок оценки: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu]
• Assessment of nutrition knowledge following the structured nutrition education program [Срок оценки: Visit 3 (Day 120) after Ren-Nu]
• Assessment of dietary intervention tolerability following the structured nutrition education program [Срок оценки: Visit 3 (Day 120) after Ren-Nu]
• Assessment of dietary intervention feasibility following the structured nutrition education program [Срок оценки: Visit 3 (Day 120) after Ren-Nu]

Критерии участия

Критерии включения

• Adult (18 years or older)

• Diagnosis of ADPKD by a physician.
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at screening using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• Appropriate control of blood pressure (i.e. entry reading <140/90) including the use of BP medications for diagnosis of hypertension.
• BMI ≥ 25 (accounting for muscle mass)
• Own an at-home blood pressure monitor (no brand requirements)
• Able to complete study-related activities (e.g., attend online classes, complete questionnaires, and proper use of medical devices)

Критерии исключения

• Intolerance or allergy to any of the ingredients in the provided medical food

• Severe or rare underlying health conditions may cause a safety risk when taking the medical food. Those underlying health conditions will be assessed by the enrolling physician and include but are not limited to:

• History of hyperkalemia
• Heart failure
• Liver cirrhosis
• Chronic kidney disease stage 4 or greater, or other renal condition that severely impairs bone mineral homeostasis.
• HIV infection
• Chronic drug or alcohol abuse
• Chronic malabsorption syndrome
• Malignancy (non-melanoma skin cancer exempted)
• Autoimmune disease
• Pregnant, planning to be pregnant, or nursing during the course of the study
• Chronic history of recurrent urinary tract infections (UTI) (≥ 3 UTIs per year)
• Diagnosis of aneurysm
• Indigestion due to hypochlorhydria (low stomach acid)
• Any other condition, that in the opinion of the enrolling physician, makes the subject an unsuitable candidate for the study.
• Current use of any of the following medications or supplements which could affect safety or compliance with this study:

• The medical food, KetoCitra®.
• Urine alkalizing agents such as sodium bicarbonate or potassium citrate
• Citrate treatments
• Immunosuppressive treatment
• Tolvaptan
• Potassium-sparing diuretics
• Somatostatin analogs
• Aluminum-containing supplements or medications such as aluminum antacids (e.g. Maalox) or aluminum-based phosphate binders.
• SGLT2 inhibitors
• Participation in another therapeutic intervention trial.
• Following a highly specialized or extreme diet that is incompatible with the interventional nutrition program (e.g. carnivore, very high protein diet for elite athletes, etc.)
• Food sensitivities or allergies that are incompatible with the interventional nutrition program.
• The subject is already adhering to a form of a ketogenic diet or related fasting regimen.
• Current or past history of disordered eating or feeding behaviors.
• History of gastric bypass.
• Active diagnosis of ulcerative colitis, Irritable Bowel Syndrome, Crohn's, or Gallbladder Disease.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cleveland Clinic — Cleveland

Идентификаторы

NCT: NCT07454174 · 24-893 · SBN2504RF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗