Short-Term Metabolic Impacts of Ren-Nu: A Dietary Program for Individuals With Polycystic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Serum Renal Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Pilot study on ketogenic diet Ren-Nu and KetoCitra supplement on ADPKD
Nutritional counseling and instruction in a ketogenic diet and nutritional food supplement
干预措施: Ren-Nu and KetoCitra (Dietary Supplement)
结局指标
主要结局
Change in Serum Renal Function
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of renal function assessment as measured by creatinine based estimated glomerular filtration rate.
Change in Serum Hepatic Function Biomarkers
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of serum liver panel biomarkers to track safety signals. Biomarkers include: AST (U/L), ALT (U/L), and LDH (U/L). Measured via standard clinical laboratory assays.
Change in Glycemic Control
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of glycemic control as measured by aggregate of Hgb A1c and Homeostatic model assessment of insulin resistance (HOMA-IR).
Change in Systemic Inflammation Markers
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of inflammatory biomarkers as an aggregate using: serum C-reactive protein \[(CRP) mg/dL\] and homocysteine (umol/L). Measured via standard clinical laboratory assays.
Change in Serum Measures of Lipids
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of of lipids using fasting serum lipid panel to track cholesterol and fat levels. This includes: total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), and triglycerides (mg/dL).
Change in 24-Hour Urine Collection to track Lithogenic Risk
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of 24-hour urine analytes in aggregate to assess lithogenic risk. The analytes will include calcium (mg/day), creatinine (mg/day), citrate (mg/day), oxalate (mg/day), uric acid (mg/day), sodium (mmol/day), chloride (mmol/day), magnesium (mg/day), ammonium (mmol/day), sulfate (mmol/day), phosphorus (mg/day), urea nitrogen (g/day), and urine pH. Measured via standard clinical laboratory assays.
Change in Glycemic Variability via a Continuous Glucose Monitor (CGM)
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in glycemic variability includes mean glucose (mg/dL) measured over a period of time and compared to before and at the end of the Ren-Nu program. This will be measured using the FreeStyle Libre 3 System.
Change in Anthropometric Measures
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in body weight (kg) and body mass index (kg/m²), calculated from measured height and weight using standardized clinic procedures.
Change in Blood Pressure
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline in systolic and diastolic blood pressure. Seated blood pressure (mmHg) is taken throughout the 4 week orientation period and the 12 week nutritional dietary program. This is measured using a calibrated automated blood pressure machine after 5 minutes of rest.
Change in Serum Fatty Acid
时间窗: Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu
Change from baseline of serum free fatty acid (FFA, mmol/L).
次要结局
- Change in health-related quality of life as assessed by the Quality of Life: Short-Form Health Survey 12 (SF-12v2)(Visit 2 (Day 0) before Ren-Nu and Visit 3 (Day 120) after Ren-Nu)
- Change in self reported mental and physical health outcomes(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(Visit 3 (Day 120) after Ren-Nu)
- Assessment of dietary intervention tolerability following the structured nutrition education program(Visit 3 (Day 120) after Ren-Nu)
- Assessment of dietary intervention feasibility following the structured nutrition education program(Visit 3 (Day 120) after Ren-Nu)
研究者
Richard Fatica
Vice Chairman Department of Kidney Medicine
The Cleveland Clinic