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

NCT04628117 | Unknown DMC

• 1 other identifier: HospitalCJIM
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (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).

  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 Outcomes (1)

• Change protein-energy wasting and dietary intake

  8 weeks

Study Arms (2)

Control

NO INTERVENTION

Nutritional counselling by individualized nutritional plan for 8 weeks.

Oral nutritional supplementation

EXPERIMENTAL

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

Interventions

Oral nutritional supplementation for kidney disease DIETARY_SUPPLEMENT

237 mls per day for 8 weeks.

Oral nutritional supplementation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil Juan I. Menchaca: lead

Related Publications (12)

• Sung CC, Hsu YC, Chen CC, Lin YF, Wu CC. Oxidative stress and nucleic acid oxidation in patients with chronic kidney disease. Oxid Med Cell Longev. 2013;2013:301982. doi: 10.1155/2013/301982. Epub 2013 Aug 24.

  PMID: 24058721 BACKGROUND

• Liakopoulos V, Roumeliotis S, Gorny X, Eleftheriadis T, Mertens PR. Oxidative Stress in Patients Undergoing Peritoneal Dialysis: A Current Review of the Literature. Oxid Med Cell Longev. 2017 Dec 27;2017:3494867. doi: 10.1155/2017/3494867. eCollection 2017.

  PMID: 29750088 BACKGROUND

• Roumeliotis S, Eleftheriadis T, Liakopoulos V. Is oxidative stress an issue in peritoneal dialysis? Semin Dial. 2019 Sep;32(5):463-466. doi: 10.1111/sdi.12818. Epub 2019 May 1.

  PMID: 31044475 BACKGROUND

• Kochlik B, Grune T, Weber D. New findings of oxidative stress biomarkers in nutritional research. Curr Opin Clin Nutr Metab Care. 2017 Sep;20(5):349-359. doi: 10.1097/MCO.0000000000000388.

  PMID: 28562491 BACKGROUND

• Domenici FA, Vannucchi MT, Jordao AA Jr, Meirelles MS, Vannucchi H. DNA oxidative damage in patients with dialysis treatment. Ren Fail. 2005;27(6):689-94. doi: 10.1080/08860220500242678.

  PMID: 16350819 BACKGROUND

• Fouque D, Kalantar-Zadeh K, Kopple J, Cano N, Chauveau P, Cuppari L, Franch H, Guarnieri G, Ikizler TA, Kaysen G, Lindholm B, Massy Z, Mitch W, Pineda E, Stenvinkel P, Trevino-Becerra A, Wanner C. A proposed nomenclature and diagnostic criteria for protein-energy wasting in acute and chronic kidney disease. Kidney Int. 2008 Feb;73(4):391-8. doi: 10.1038/sj.ki.5002585. Epub 2007 Dec 19.

  PMID: 18094682 BACKGROUND

• Carrero JJ, Stenvinkel P, Cuppari L, Ikizler TA, Kalantar-Zadeh K, Kaysen G, Mitch WE, Price SR, Wanner C, Wang AY, ter Wee P, Franch HA. Etiology of the protein-energy wasting syndrome in chronic kidney disease: a consensus statement from the International Society of Renal Nutrition and Metabolism (ISRNM). J Ren Nutr. 2013 Mar;23(2):77-90. doi: 10.1053/j.jrn.2013.01.001.

  PMID: 23428357 BACKGROUND

• Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22.

  PMID: 23698226 BACKGROUND

• Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

  PMID: 32390133 BACKGROUND

• Prasad N, Gupta A, Sinha A, Sharma RK, Kumar A, Kumar R. Changes in nutritional status on follow-up of an incident cohort of continuous ambulatory peritoneal dialysis patients. J Ren Nutr. 2008 Mar;18(2):195-201. doi: 10.1053/j.jrn.2007.08.002.

  PMID: 18267212 BACKGROUND

• Martin-Del-Campo F, Gonzalez-Espinoza L, Rojas-Campos E, Ruiz N, Gonzalez J, Pazarin L, Cueto-Manzano AM. Conventional nutritional counselling maintains nutritional status of patients on continuous ambulatory peritoneal dialysis in spite of systemic inflammation and decrease of residual renal function. Nephrology (Carlton). 2009 Aug;14(5):493-8. doi: 10.1111/j.1440-1797.2008.01081.x.

  PMID: 19674317 BACKGROUND

• Ikizler TA, Burrowes JD, Byham-Gray LD, Campbell KL, Carrero JJ, Chan W, Fouque D, Friedman AN, Ghaddar S, Goldstein-Fuchs DJ, Kaysen GA, Kopple JD, Teta D, Yee-Moon Wang A, Cuppari L. KDOQI Clinical Practice Guideline for Nutrition in CKD: 2020 Update. Am J Kidney Dis. 2020 Sep;76(3 Suppl 1):S1-S107. doi: 10.1053/j.ajkd.2020.05.006.

  PMID: 32829751 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Protein-Energy Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Protein Deficiency; Deficiency Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial with two-parallel-group in stable continuous ambulatory peritoneal dialysis patients.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 13, 2020
• Study Start: October 4, 2021
• Primary Completion: May 28, 2022
• Study Completion: March 11, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11