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

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04628117
• Other study ID #: HospitalCJIM
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: March 11, 2023

Study information

• Verified date: November 2020
• Source: Hospital Civil Juan I. Menchaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: March 11, 2023
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Oral nutritional supplementation for kidney disease
237 mls per day for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil Juan I. Menchaca

References & Publications (12)

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. Review. — View Citation

Domenici FA, Vannucchi MT, Jordão AA Jr, Meirelles MS, Vannucchi H. DNA oxidative damage in patients with dialysis treatment. Ren Fail. 2005;27(6):689-94. — View Citation

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, Treviño-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. Epub 2007 Dec 19. Erratum in: Kidney Int. 2008 Aug;74(3):393. Trevinho-Becerra, A [corrected to Treviño-Becerra, A]. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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:CD012616. doi: 10.1002/14651858.CD012616.pub2. — View Citation

Martín-Del-Campo F, González-Espinoza L, Rojas-Campos E, Ruiz N, González J, Pazarín 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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