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

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ClinicalTrials.gov Identifier: NCT04628117
Recruitment Status : Not yet recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Francisco Gerardo Yanowsky Escatell, Hospital Civil Juan I. Menchaca

Study Description
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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.


Condition or disease Intervention/treatment Phase
Oxidative Stress Protein-Energy Wasting Malnutrition Protein-Energy Malnutrition Oral Nutritional Supplements Peritoneal Dialysis Dietary Supplement: Oral nutritional supplementation for kidney disease Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial with two-parallel-group in stable continuous ambulatory peritoneal dialysis patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assess Effect of Oral Nutritional Supplementation on Oxidative Stress Levels in Protein-energy Wasting Patients With Continuous Ambulatory Peritoneal Dialysis
Estimated Study Start Date : October 4, 2021
Estimated Primary Completion Date : May 28, 2022
Estimated Study Completion Date : March 11, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Nutritional counselling by individualized nutritional plan for 8 weeks.
Experimental: Oral nutritional supplementation
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
237 mls per day for 8 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in oxidative stress levels, oxidants (products of Lipoperoxidation, 8-IP, NO), antioxidants (SOD, catalase, GPx, TAC), and oxidative DNA damage (8-OHdG, hOGG1). [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Change protein-energy wasting and dietary intake [ Time Frame: 8 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Francisco Gerardo Yanowsky Escatell, Principal Investigator, Hospital Civil Juan I. Menchaca
ClinicalTrials.gov Identifier: NCT04628117    
Other Study ID Numbers: HospitalCJIM
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Wasting Syndrome
Protein-Energy Malnutrition
Cachexia
Nutrition Disorders
Emaciation
 Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Protein Deficiency
Deficiency Diseases