Specialized oral supplement for improving nutrition in chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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
• Email: paola.alvarado@nin.com.mx
• Phone: 011 52 3320587471

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.