Effect of Plant Dominant Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune , India - A Randomized Prospective Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in the nutritional status and dietary intake, frequency of the symptoms (Vomiting, diarrhea, nausea, anorexia, loss of appetite. Regulation of the renal biochemical parameters (Hemoglobin,E-GFR , Urine-albumin creatinine ratio, Uric acid, electrolytes,HbA1C,Blood pressure monitoring).Compliance and adherence rate to diet.
研究概览
简要总结
The study titled "Effect of Plant Dominant Low Protein Diet among Chronic Kidney Disease Patients from Selected Hospitals in Pune, India - A Randomized Prospective Controlled Study" aims to investigate the impact of a plant-based low protein diet on patients with chronic kidney disease (CKD). Chronic kidney disease is a progressive condition characterized by gradual loss of kidney function, and dietary management plays a crucial role in slowing disease progression and managing symptoms.
Summary: The trial involves chronic kidney disease patients from selected hospitals in Pune, India, who are randomized into two groups: one receiving a plant-dominant low protein diet and the other continuing with a standard diet. The study is prospective and controlled, meaning that patients are followed over time and their outcomes are compared between the two groups. Key measures include kidney function parameters, nutritional status, and dietray compliance and adherence.
Purpose: The primary purpose of the study is to determine whether a plant-dominant low protein diet can significantly improve kidney function and overall health outcomes in CKD patients compared to a standard diet. This includes evaluating the effects on biochemical markers of kidney function, nutritional deficiencies,dietray intake, adherence and compliance to the diet . The study aims to provide evidence on the benefits and feasibility of implementing a plant-based dietary approach in the management of CKD, potentially offering a sustainable and beneficial dietary strategy for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Location: Pune district Maharashtra India Food habits: Both vegetarian and non-vegetarian food habits.
- •Nutritional status :well-nourished to moderately malnourished (as per the SGA tool and nutrition focused physical exam) Activity: light to medium physical activity Willing to participate or consenting to the study.
排除标准
- •Not diagnosed with CKD Patient of CKD stage 4-5 (ESRD) with GFR (less than 30 mL/min/1.73 m²) pediatric and geriatric population Outside Pune district Maharashtra India,An acute or chronic communicable infection, pregnancy, lactation or any critical illness, heart disease, liver disease, cancer, Malabsorptive diseases like short bowel syndrome or Irritable bowel disease, continuous supportive dialysis care for management of the disease.
- •Severely malnourished nutritional status Bed ridden; physically-mentally handicapped, dependent individuals Unwilling to participate/not giving consent to the study.
结局指标
主要结局
Change in the nutritional status and dietary intake, frequency of the symptoms (Vomiting, diarrhea, nausea, anorexia, loss of appetite. Regulation of the renal biochemical parameters (Hemoglobin,E-GFR , Urine-albumin creatinine ratio, Uric acid, electrolytes,HbA1C,Blood pressure monitoring).Compliance and adherence rate to diet.
时间窗: 4 months
次要结局
- 1.Monitor the improvement in nutritional status,dietray intake after the initiation of plant dominant low protein diet
研究者
Anindita Ghosh
Symbiosis International University