Specialized oral supplement for improving nutrition in chronic kidney disease

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)

This study is testing a special nutritional shake and counseling to see if it can help people with chronic kidney disease who aren't on dialysis feel better and improve their nutrition.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: NIN Institute (industry)
• Locations: 1 site (Guadalajara, Jalisco)
• Trial ID: NCT06576479 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a specialized oral nutritional supplement on the nutritional status and quality of life of patients with chronic kidney disease (CKD) who are not on dialysis. It aims to address the high prevalence of protein-energy wasting (PEW) among CKD patients by providing a nutritious shake and nutritional counseling to enhance their energy and protein intake. The study will evaluate the impact of these interventions on patients' overall health and nutritional outcomes, particularly focusing on those with specific dietary restrictions and gastrointestinal symptoms. By validating the therapeutic effects of this nutritional approach, the study seeks to improve the management of malnutrition in CKD patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with diabetic kidney disease and an eGFR between 15 and 60 ml/min/1.73m² who exhibit signs of protein-energy wasting.

Not a fit: Patients with serious complications or those currently consuming food supplements or keto analogues may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the nutritional status and quality of life for patients with chronic kidney disease.

How similar studies have performed: Previous studies have shown that specialized nutritional supplements can effectively improve nutritional intake in similar patient populations, indicating a promising approach.

Eligibility criteria

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 this trial is running

Guadalajara, Jalisco

• Hospital Civil Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico (RECRUITING)

Study contacts

• Principal investigator: Paola Azucena Alvarado Pelayo, Bachelor — Hospital Civil Fray Antonio Alcalde
• Study coordinator: Paola Azucena Alvarado Pelayo, Bachelor

Conditions: Chronic Kidney Diseases, Protein-Energy Malnutrition, chronic kidney disease, PEW, nutrition