Potassium (K) Handling in Advanced Chronic Kidney Disease (K-HANDLE CKD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- Fasting Serum Potassium Levels (mmol/L)
研究概览
简要总结
What is this study about?
This clinical trial is designed to learn how potassium from different types of food affects blood potassium levels and overall health in people with chronic kidney disease (CKD, stages 3B-5).
People with CKD are often advised to avoid potassium-rich foods, even though fresh fruits and vegetables are important for good health. However, potassium in processed foods (such as packaged snacks and ready-made meals) may be absorbed differently than potassium from fresh foods.
This study will compare minimally processed vs. ultra-processed foods to determine how different sources of potassium affect potassium levels and help create better dietary recommendations for people with CKD.
What are the study goals?
The study will answer:
- Does potassium from fresh foods (like fruits and vegetables) affect blood potassium differently than potassium from processed foods?
- How does dietary potassium impact potassium absorption and excretion in people with CKD?
Researchers will compare the effects of four diets to understand how low and normal-potassium rich diets from fresh vs. processed foods influence:
- Blood potassium levels
- Body composition (muscle, fat, and fluid balance)
- Vascular health
What will participants do?
Participants will follow four different 10-day diets over the course of the study. All food will be provided at no cost. These diets are:
- Minimally processed with low-potassium content
- Minimally processed with normal potassium content
- Ultra-processed with with low-potassium content
- Ultra-processed with normal potassium content
There will be 16-day breaks (washout period) between diets where participants return to their normal eating habits.
During the study, participants will:
- Pick up prepared meals from the research center approximately 3 times per week.
- Attend checkups for weight, blood pressure, and blood tests.
- Provide urine samples to track potassium levels.
- Wear a comfortable, cuff-free blood pressure monitor at home.
- Keep a study journal to track diet, medications, and symptoms.
- Complete questionnaires about diet satisfaction and health changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Participants aged ≥18 years living with stage 3B-5 CKD (estimated glomerular filtration rate ≥ 15 mL/min/1.73m2) on conservative kidney management (not on dialysis).
- •Able and willing to follow a controlled feeding regimen, attend in-person visits, provide informed consent, and comply with study procedures.
排除标准
- •Pregnant or lactating women.
- •Transitioning transgender individuals.
- •Individuals with strict dietary preferences (e.g., vegetarians, vegans) or allergies/intolerance that would preclude participation in the diet phases.
- •Kidney Function
- •Foreseen start of renal replacement therapy within the next 6 months.
- •Acute kidney injury in the past 3 months.
- •2-year Kidney Failure Risk Equation > 40%.
- •Preemptive kidney transplant planned within the next 6 months.
- •History of kidney transplant.
- •Active glomerulonephritis. Comorbidities
- •Acute myocardial infarction or stroke within the past 6 months.
- •Active cancer.
- •Ileostomy, short bowel syndrome or inflammatory bowel disease.
- •Body mass index < 18.5 or ≥
- •New York Heart Association Class III or IV congestive heart failure.
- •History of ventricular arrhythmia.
- •Major surgery within the past 3 months.
- •Active autoimmune disease.
- •Glycated hemoglobin > 10% within the past 3 months.
- •Gastroparesis.
- •Chronic nausea and vomiting.
- •Intensive care unit admission within the past 3 months.
- •Significant psychiatric disease.
- •Uncontrolled blood pressure (above 160/100). Current Use of Medications/Supplements
- •Immunosuppressives.
- •Potassium binders.
- •Motility agents.
- •More than 2 medications that inhibit renal potassium excretion (e.g., angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, mineralocorticoid receptor antagonists).
- •Supplements known to influence potassium levels. Potassium-Related Conditions
- •Potassium > 5.5 mmol/L in more than 3 episodes within the past year.
- •Participants with genetic issues affecting potassium handling (e.g. Barter and Liddle syndrome) or other unique health conditions that could interfere with potassium handling.
- •Intervention-related Conditions
- •Fluid volume status or hypertension being actively managed. Other Factors
- •Documented non-adherence to medications or other therapeutic measures.
- •Use of tube feeding or parenteral nutrition.
研究组 & 干预措施
Low-potassium, ultra-processed diet
Participants in this group will follow a diet consisting of ultra-processed foods with restricted potassium content.
干预措施: Low-potassium, ultra-processed diet (Other)
Normal potassium-rich, minimally processed diet
Participants in this group will follow a diet consisting of minimally processed foods with a normal potassium content.
干预措施: Normal potassium-rich, minimally processed diet (Other)
Normal potassium-rich, ultra-processed diet
Participants in this group will follow a diet consisting of ultra-processed foods with a normal potassium content.
干预措施: Normal potassium-rich, ultra-processed diet (Other)
Low-potassium, minimally processed diet
Participants in this group will follow a diet consisting of minimally processed foods with restricted potassium content.
干预措施: Low-potassium, minimally processed diet (Other)
结局指标
主要结局
Fasting Serum Potassium Levels (mmol/L)
时间窗: Days 10, 36, 62, and 88.
This measure assesses the concentration of potassium in participants' blood after fasting overnight. Normal potassium levels typically range from 3.5 to 5.0 mmol/L.
次要结局
- Postprandial Whole-Blood Potassium Response (mmol/L)(15, 30, 60, 90, 120, 150, 180 minutes post-meal at days 10, 36, 62, and 88.)
- Body water (L)(Baseline and days 10, 36, 62, and 88.)
- Potassium Bioavailability(Days 7-9, 33-35, 59-61, 85-87.)
- Body Composition (kg)(Baseline and days 10, 36, 62, and 88.)
- 24h blood pressure (mmHg)(Days 8-10, 34-36, 60-62, and 86-88.)
- Dietary Satisfaction Questionnaire(Days 10, 36, 62, and 88.)