Effect of a Specialized Oral Supplement on Nutritional Status and Quality of Life in Non-dialysis CKD
Recruiting · NCT06576479 · Interventional (participants receive a specific treatment) · Lead sponsor: NIN Institute
View the official record on ClinicalTrials.gov →Interventions studied
Nutritional counselingNutritious Shake
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Hospital Civil Fray Antonio Alcalde - Guadalajara, Jalisco, Mexico