Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD

NCT06576479 | Recruiting

• 1 other identifier: NI0001/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Protein-Energy Malnutrition

Keywords

chronic kidney disease; PEW; nutrition

Outcome Measures

Primary Outcomes (2)

• Serum Albumin (g/dl)

  Changes in serum albumin (g/dl) for all the patients at baseline and month 4.

  baseline intervention and 4 months

• Dietary intake (kcal/kg/day)

  Changes in dietary caloric intake of patients at baseline and month 4.

  baseline intervention and 4 months

Secondary Outcomes (2)

• Adherence to nutritional treatment

  baseline intervention and 4 months

• Adverse effects

  baseline intervention and 4 months

Study Arms (2)

Arm Intervention

EXPERIMENTAL

Intervention group: The specialized oral supplement is provided, with the consumption of 1 serving (70g-dissolved in 237 ml natural water) per day in conjunction with individualized nutritional counseling. For 4 months

Dietary Supplement: Nutritious Shake

Arm no Intervention

OTHER

Control group: They receive specialized nutrition considering the recommendations of the clinical practice guidelines for CKD. For 4 months

Behavioral: Nutritional counseling

Interventions

Nutritious Shake DIETARY_SUPPLEMENT

Powder 70 g/d diluted in 237 ml natural water

Also known as: NIN

Arm Intervention

Nutritional counseling BEHAVIORAL

Specialized nutritional recommendations for CKD

Arm no Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Death.

Sponsors & Collaborators

• NIN Institute: lead
• Hospital Civil de Guadalajara: collaborator

Study Sites (1)

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Related Publications (10)

• 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

• Riella MC. Nutritional evaluation of patients receiving dialysis for the management of protein-energy wasting: what is old and what is new? J Ren Nutr. 2013 May;23(3):195-8. doi: 10.1053/j.jrn.2013.01.023.

  PMID: 23611546 BACKGROUND

• Perez-Torres A, Gonzalez Garcia ME, San Jose-Valiente B, Bajo Rubio MA, Celadilla Diez O, Lopez-Sobaler AM, Selgas R. Protein-energy wasting syndrome in advanced chronic kidney disease: prevalence and specific clinical characteristics. Nefrologia (Engl Ed). 2018 Mar-Apr;38(2):141-151. doi: 10.1016/j.nefro.2017.06.004. Epub 2017 Jul 26. English, Spanish.

  PMID: 28755901 BACKGROUND

• Kovesdy CP, Kopple JD, Kalantar-Zadeh K. Management of protein-energy wasting in non-dialysis-dependent chronic kidney disease: reconciling low protein intake with nutritional therapy. Am J Clin Nutr. 2013 Jun;97(6):1163-77. doi: 10.3945/ajcn.112.036418. Epub 2013 May 1.

  PMID: 23636234 BACKGROUND

• Zhang X, Bansal N, Go AS, Hsu CY. Gastrointestinal symptoms, inflammation and hypoalbuminemia in chronic kidney disease patients: a cross-sectional study. BMC Nephrol. 2015 Dec 11;16:211. doi: 10.1186/s12882-015-0209-z.

  PMID: 26651991 BACKGROUND

• Paes-Barreto JG, Silva MI, Qureshi AR, Bregman R, Cervante VF, Carrero JJ, Avesani CM. Can renal nutrition education improve adherence to a low-protein diet in patients with stages 3 to 5 chronic kidney disease? J Ren Nutr. 2013 May;23(3):164-71. doi: 10.1053/j.jrn.2012.10.004. Epub 2012 Nov 27.

  PMID: 23194841 BACKGROUND

• Tomayko EJ, Kistler BM, Fitschen PJ, Wilund KR. Intradialytic protein supplementation reduces inflammation and improves physical function in maintenance hemodialysis patients. J Ren Nutr. 2015 May;25(3):276-83. doi: 10.1053/j.jrn.2014.10.005. Epub 2014 Nov 25.

  PMID: 25455421 BACKGROUND

• Kalantar-Zadeh K, Cano NJ, Budde K, Chazot C, Kovesdy CP, Mak RH, Mehrotra R, Raj DS, Sehgal AR, Stenvinkel P, Ikizler TA. Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat Rev Nephrol. 2011 May 31;7(7):369-84. doi: 10.1038/nrneph.2011.60.

  PMID: 21629229 BACKGROUND

• Cheu C, Pearson J, Dahlerus C, Lantz B, Chowdhury T, Sauer PF, Farrell RE, Port FK, Ramirez SP. Association between oral nutritional supplementation and clinical outcomes among patients with ESRD. Clin J Am Soc Nephrol. 2013 Jan;8(1):100-7. doi: 10.2215/CJN.13091211. Epub 2012 Oct 18.

  PMID: 23085729 BACKGROUND

• Satirapoj B, Prapakorn J, Punpanich D, Pongsuparbchon C, Supasyndh O. The effect of ONCE Renal on minerals and electrolytes in predialysis patients with chronic kidney disease. Int J Nephrol Renovasc Dis. 2016 Apr 5;9:81-6. doi: 10.2147/IJNRD.S98179. eCollection 2016.

  PMID: 27103839 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Protein-Energy Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Paola Azucena Alvarado Pelayo, Bachelor

  Hospital Civil Fray Antonio Alcalde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Azucena Alvarado Pelayo, Bachelor

CONTACT

011 52 3320587471; paola.alvarado@nin.com.mx

Ari Cisneros Hernández, Master

CONTACT

011 52 3335762299; aricisneroshernandez@gmail.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Principal

Model Details: The intervention group receives specialized oral nutritional supplements plus nutritional counseling, the control group only receives nutrition counseling. Both groups receive laboratory studies (blood and urine) as well as body composition analysis with the use of electronic bioimpedance.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 28, 2024
• Study Start: July 10, 2018
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)