Tests a nutrition shake in adults with chronic kidney disease not on dialysis
Tests a specialized oral nutrition shake in adults with kidney disease and poor nutrition.
Plain-language title generated from the registry record
Registry title: Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Key facts
- Where
- Guadalajara, MexicoSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT06576479, who can take part
Where in Mexico
- Hospital Civil Fray Antonio AlcaldeGuadalajara, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NIN Institute
- Trial code
- NCT06576479
- Record updated
- 18 December 2024
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Previous hospitalizations in the last month; Initiation of replacement therapy; 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); 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); Patients with actual consumption of food supplements and / or keto analogues; Elimination Criteria:; Diagnosis of any comorbidity during the intervention period; Identification of adverse effects; Withdrawal of voluntary participation by the patient; Death.