Validation of the Therapeutic Effect and Safety of a Specialized Oral Supplement on the Nutritional Status and Quality of Life in Patients with Chronic Kidney Disease Without Replacement Therapy: (Grade G3a, G3b, G4 and G5)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Serum Albumin (g/dl)
研究概览
简要总结
In patients whit chronic kidney disease (CKD) there is a high prevalence of nutritional disorders and negative changes in body composition, which is strongly associated with an increased risk of morbidity and mortality.
详细描述
Epidemiological studies have reported that between 30 and 50% of patients with kidney disease show signs of malnutrition and that specifically in patient with CKD in stages 4-5 without replacement therapy, the prevalence of protein energy wasting (PEW) can be up to 45%.
Many factors influence the development of PEW, however, one main factor is insufficient intake of energy and macronutrients. The main obstacle that prevents the patient from meeting their nutritional requirements is the presence of gastrointestinal symptoms. In addition to this, dietary restrictions, lack of adherence to eating plans and the presence of digestive and psychological abnormalities of the patient, contribute directly to the patient directly contribute to insufficient energy and protein intake. Therefore, there is a need for evidence-based nutritional treatment strategies that facilitate the patient's achievement of their nutritional requirements and maintain or improve their nutritional supplements in patients with CKD has been shown to be a good treatment strategy.
Specifically in patients with CKD without replacement therapy, it has been observed that the use of specialized nutritional supplements can contribute to increasing their energy, fat, and fiber intake, while at the same time achieving a decrease in protein intake without causing any change in serum minerals or electrolytes.
This project will provide practical information for the validation of the therapeutic effect of a new specialized food supplement on the nutritional status and quality of life in patients with CKD without replacement therapy, which will be useful both for health professionals and for the patients themselves.
MAIN OBJETIVE To assess the effect and safety of the use of a specialized food supplement on the nutritional status and quality of life of patients with CKD and PEW without replacement therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The participant takes a random envelope without seeing, which the researcher receives and is automatically assigned the group in which he will remain until satisfactorily finished.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Patients with diabetic kidney with eGFR <60 ml / min / 1.73m2 and ≥15 ml / min / 1.73m2, (stage G3a, G3b and G4 respectively)
- •Patients with protein energy expenditure (defined by serum albumin < 3.8 g/dl)
- •Patients with protein energy expenditure (defined by 24-hour recall less than a dietary protein intake <0.6 g/kg/d or have a consumption <25 kcal/kg/d
- •Patients who can read and write (or primary caregiver)
- •Domicile within the metropolitan area
排除标准
- •Previous hospitalizations in the last month
- •Patients with serious complications (chronic infection, septicemia, cancer, HIV, Alzheimer's, uncontrolled heart failure, liver failure, cerebrovascular syndrome, malabsorption syndrome, or allergy to any ingredient in the nutritional supplement)
- •Patients with actual consumption of food supplements and / or keto analogues.
- •Elimination Criteria:
- •Failure to attend nutritional assessment and biochemical testing at baseline, 2 months, and end of the study.
- •Failure to take the supplement >10% (>12 failed doses).
- •Diagnosis of any comorbidity during the intervention period.
- •Initiation of replacement therapy.
- •Identification of adverse effects.
- •Withdrawal of voluntary participation by the patient.
结局指标
主要结局
Serum Albumin (g/dl)
时间窗: baseline intervention and 4 months
Changes in serum albumin (g/dl) for all the patients at baseline and month 4.
Dietary intake (kcal/kg/day)
时间窗: baseline intervention and 4 months
Changes in dietary caloric intake of patients at baseline and month 4.
次要结局
- Adherence to nutritional treatment(baseline intervention and 4 months)
- Adverse effects(baseline intervention and 4 months)
研究者
Ari Cisneros-Hernández
Investigador Principal
Hospital Civil de Guadalajara