RecruitingNot ApplicableNCT06576479

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

Validation of the Therapeutic Effect and Safety of a Specialized Oral Supplement on the Nutritional Status and Quality of Life in Patients with Chronic Kidney Disease Without Replacement Therapy: (Grade G3a, G3b, G4 and G5)

Sponsor

NIN Institute

Enrollment

50 participants

Start Date

Jul 10, 2018

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases Protein-Energy Malnutrition

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

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

Exclusion Criteria11

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.