Effect of Oral Nutritional Supplementation on Oxidative Stress in Protein-energy Wasting Patients With Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
End-stage kidney disease (ESKD) represents a serious public health problem in Mexico. Data from the United States Renal Data System (USRDS) have reported that the region of Jalisco (Mexico) is one of the places with the highest incidence rate of treated ESKD and use of peritoneal dialysis (PD). In patients with ESKD, oxidative stress (OS) has been recognized as a potential source of morbidity and mortality, since it is involved in the pathogenesis of atherosclerosis and other complications of ESRD. This can induce damage to DNA (nucleic acid), proteins, carbohydrates, and lipids. Another common complication in ESKD patients receiving PD is protein-energy wasting (PEW), which is characterized by the decline in the body stores of protein and energy fuels (that is, body protein and fat masses) due to the multiple nutritional and catabolic alterations that occur in this condition. Diverse factors can affect the nutritional and metabolic status of patients with PD, for which they require interventions to reverse protein and energy depletion. Nutritional counseling can be a useful tool in PD patients in order to improve compliance with nutritional recommendations. The strategies more used for PEW include oral nutritional supplementation. Therefore, the purpose of this study is assess the effect of oral nutritional supplementation on OS in PEW patients with PD.

Detailed Description
-----------------
The detection of patients is carried out in the Nephrology Service of the Hospital Civil de Guadalajara Dr. Juan I. Menchaca where the selection and exclusion criteria are evaluated. The probabilistic group assignment is carried out using a sealed and opaque envelope. Control group: only nutritional counselling for 8 weeks. Intervention group: nutritional counselling plus 237 mls per day of oral nutritional supplement for kidney disease. Initial evaluation includes, anthropometric parameters and dietary intake. Demographic characteristics and OS levels, such as oxidants, antioxidants and oxidative DNA damage. All nutritional counselling, dietary intake, medical nutrition theraphy (oral nutritional supplementation), assessment of OS levels, and anthropometric parameters will perform at 0, 4 and 8 weeks of follow up. Protein-energy wasting assessment only in the 0 and 8 weeks.

Official Title
-----------------
Assess Effect of Oral Nutritional Supplementation on Oxidative Stress Levels in Protein-energy Wasting Patients With Continuous Ambulatory Peritoneal Dialysis

Conditions
-----------------
Peritoneal Dialysis, Oxidative Stress, Protein-Energy Wasting, Malnutrition, Protein-Energy Malnutrition, Oral Nutritional Supplements

Intervention / Treatment
-----------------
* Dietary Supplement: Oral nutritional supplementation for kidney disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of protein-energy wasting evaluated by 7-point Subjective Global Assessment (moderate/severe), and Malnutrition-inflammation Score (a score ≥ 6). Male and female patients Age ≥ 18 and <60 years Receive continuous ambulatory peritoneal dialysis with at least 3 months of initiation of renal replacement therapy Patients without clinical or biochemical evidence of any infectious process (peritonitis, urosepsis, endocarditis, soft tissue infection, pneumonia, etc) or inflammatory systemic disease (systemic lupus erythematosus, vasculitis, connective tissue disease) Written informed consent Exclusion Criteria: Supplementation with exogenous antioxidants 2 months prior Smoking less than 1 year Intermittent peritoneal dialysis or automated peritoneal dialysis PD catheter dysfunction Known allergy or intolerance to oral nutritional supplement for renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial with two-parallel-group in stable continuous ambulatory peritoneal dialysis patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Nutritional counselling by individualized nutritional plan for 8 weeks. | |
| Experimental: Oral nutritional supplementation<br>Nutritional counselling by individualized nutritional plan plus oral nutritional supplementation for renal disease (237 mls per day) for 8 weeks. | Dietary Supplement: Oral nutritional supplementation for kidney disease<br>* 237 mls per day for 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oxidative stress levels, oxidants (products of Lipoperoxidation, 8-IP, NO), antioxidants (SOD, catalase, GPx, TAC), and oxidative DNA damage (8-OHdG, hOGG1). | As measured by the of OS markers, 10 mL of blood samples will be taken prior to nutritional evaluation, 5 mL with 0.1% of ethylenediaminetetraacetic (EDTA) tube and other 5 mL in dry tube. The blood will be centrifuged at 10,000 rpm for 10 min at room temperature; supernatants were stored in aliquots at -80°C until its final processing. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change protein-energy wasting and dietary intake | Description: As measured by 7-point Subjective Global Assesment (SGA), SGA of 1-2 for severe PEW, 3-5 for mild-moderate protein energy wasting will be considered as presence of protein-energy wasting and malnutrition inflammation score (MIS) a score ≥ 6 will be considered as the presence of protein-energy wasting. | 8 weeks |