NCT06932042招募中不适用
Plant Dominant Low-protein Diet for Conservative Management of Chronic Kidney Disease: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Metabolic acidosis assessed by PTCO2
研究概览
简要总结
The goal of this clinical trial is to learn if a plant-dominant low protein diet, referred to as PLADO diet, works to decrease metabolic acidosis, a major risk factor for chronic kidney disease (CKD) progression, in adults with CKD. It will also learn about the safety, viability, and economic attractiveness of this diet.
The main questions it aims to answer are:
- Is the PLADO diet more effective in managing metabolic acidosis in comparison with the standard-of-care CKD diet in adults with CKD?
- Is the PLADO diet safe, viable, and economically attractive adults with CKD?
Researchers will compare the PLADO diet to the standard-of-care CKD diet to see if the PLADO diet works better to decrease metabolic acidosis.
Participants will:
- Receive nutrition education of the PLADO diet or the standard-of-care CKD diet via monthly sessions for 6 months.
- Visit the clinic monthly for 6 months, then after 3 months for checkups and tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients aged 18 years and above, having controlled glycemic and blood pressure parameters on treatment, with an established diagnosis of stages 3-5 CKD and an estimated GFR ≤59 ml/min/1.73 m2 stable for at least three months, and with a normal nutritional status as defined by the GLIM criteria, attending the CKD outpatient clinics at LAUMC-RH, willing to undergo the baseline screening and attend the monthly face-to-face visits at the outpatient department at LAUMC-RH.
排除标准
- •Patients with overt infection, persistent anorexia, vomiting, or diarrhea within the last month, presence of wasting diseases such as cancer, tuberculosis, liver failure, heart failure, and those with serum potassium >5.5 mEq/L during the past 6 months.
研究组 & 干预措施
PLADO
Experimental
干预措施: PLADO (Other)
Standard-of-care diet
Active Comparator
干预措施: Standard-of-care diet (Other)
结局指标
主要结局
Metabolic acidosis assessed by PTCO2
时间窗: Baseline, Monthly for 6 months, Month 9
次要结局
- Triceps Skinfold thickness(Baseline, Months 3, 6, and 9)
- Serum Potassium (K)(Baseline, Monthly for 6 months, Month 9)
- Body weight(Baseline, Months 3, 6, and 9)
- %Weight Change(Months 3, 6, and 9)
- Body Fat Percentage(Baseline, Months 3, 6, and 9)
- Fat Free Mass Percentage(Baseline, Months 3, 6, and 9)
- Total Body Water Percentage(Baseline, Months 3, 6, and 9)
- Blood Urea Nitrogen (BUN)(Baseline, Monthly for 6 months, Month 9)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline, Monthly for 6 months, Month 9)
- Serum Phosphorus (P)(Baseline, Monthly for 6 months, Month 9)
- C-Reactive Protein (CRP)(Baseline, Months 3, 6, and 9)
- Albumin(Baseline, Months 3, 6, and 9)
- Hemoglobin(Baseline, Months 3, 6, and 9)
- Hematocrit(Baseline, Months 3, 6, and 9)
- Mean Corpusculum Volume (MCV)(Baseline, Months 3, 6, and 9)
- Ferritin(Baseline, Months 3, 6, and 9)
- Glycated hemoglobin A1C(Baseline, Months 3, 6, and 9)
- Urinary microalbumin: creatinine ratio (UmACR)(Baseline, Months 3, 6, and 9)
- Urinary potassium excretion(Baseline, Months 3, 6, and 9)
- Urinary phosphorus excretion(Baseline, Months 3, 6, and 9)
- Global Leadership Initiative on Malnutrition (GLIM) criteria(Baseline, Months 3, 6, and 9)
- Total Caloric intake per kilogram body weight (Kcal/kg)(Baseline, Months 3, 6, and 9)
- Total dietary protein intake per kilogram body weight (g/kg)(Baseline, Months 3, 6, and 9)
- Carbohydrate intake percentage (%)(Baseline, Months 3, 6, and 9)
- Total fat intake percentage (%)(Baseline, Months 3, 6, and 9)
- Trans fat intake percentage (%)(Baseline, Months 3, 6, and 9)
- Total potassium intake (g)(Baseline, Months 3, 6, and 9)
- Total phosphorus intake (g)(Baseline, Months 3, 6, and 9)
- Total sodium intake (g)(Baseline, Months 3, 6, and 9)
- Nutrition focused physical examination (NFPE)(Baseline, Months 3, 6, and 9)
- Gastrointestinal Symptoms(Baseline, Monthly for 6 months, Month 9)
- Health-related Quality of Life(Baseline, Months 3, 6, and 9)
- Costs(Baseline, Months 3, 6, and 9)
- Muscle strength (kg)(Baseline, Months 3, 6, and 9)
研究者
Rana Rizk
Assistant Professor
Lebanese American University
研究点 (1)
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