Impact of nutrition intervention on clinical and metabolic outcomes in pre-dialysis CKD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serum creatinine and estimated glomerular filtration rate (CKD-EPI equation, 2009)
研究概览
简要总结
The current study is a single-arm interventional trial to assess the effect of an anti-inflammatory dietary pattern on disease-related biochemical parameters, body composition and quality of life in pre-dialysis CKD patients. Patients will be advised to follow a 7-day anti-inflammatory dietary pattern, personalized according to their nutrient recommendations and disease stage, for a minimum of 6 weeks. The pattern will consist of commonly consumed and available recipes and foods, formulated into a meal pattern. The anti-inflammatory nature of the diet during planning and measuring the impact of the proposed meal plan will be quantified using a dietary inflammatory index score algorithm via multiple 24-hour recalls. The primary outcome of the study will be markers of disease progression, i.e. serum creatinine and estimated glomerular filtration rate, measured at baseline and the end of the study period. Other outcomes such as markers of inflammatory status, oxidative stress, total antioxidant capacity, body composition measured by a multi-frequency bioimpedance-based analyzer and quality of life using the KDQOL SF-36 questionnaire will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed Chronic Kidney Disease patients with or without diabetes, hypertension and cardiovascular disease.
排除标准
- •Patients on dialysis, renal transplant recipients, with physiological alterations such as pregnancy/lactation, physical impairment/disabilities, recent history of trauma, infection, major surgery or any other chronic catabolic illness such as COPD, cancer etc.
结局指标
主要结局
Serum creatinine and estimated glomerular filtration rate (CKD-EPI equation, 2009)
时间窗: 0th and 6th week
次要结局
- Serum creatinine and estimated glomerular filtration rate (CKD-EPI equation, 2009)(3rd week)
- Inflammatory marker - CRP by LEIT method(0th, 3rd and 6th week)
- Oxidative stress marker - Malondialdehyde by TBARS method(0th, 3rd and 6th week)
- Total antioxidant capacity - FRAP and uric acid independent FRAP assay(0th, 3rd and 6th week)
- Serum electrolytes, phosphorous, calcium, protein, albumin (kit methods)(0th, 3rd and 6th week)
- Lipid profile - Triglycerides, cholesterol, HDL-C (enzymatic kit methods), calculated LDL-C (Martin Hopkins equation)(0th, 3rd and 6th week)
- Quality of Life - KDQOL-36 SF questionnaire(0th and 6th week)
- Body composition analysis by a multi-frequency bio-impedance-based analyzer, InBody 770(0th, 3rd and 6th week)
研究者
Prathiksha R Bhat
University of Mysore
