None listed
Conditions
Interventions
Others : Intervention is divided into a test group and a control group.
1. test group(Low-protein/low-mineral dietary food intake group)
It provides medical food (test food), educates on how to consu
Sponsors
Kyung Hee University Global Campus
Dankook Univeristy Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chronic kidney disease stage 3 and 4 patients with an eGFR of 15 to 60 mL/min/1.73 m² according to CKD-EPI criteria. 2. Individuals who have voluntarily provided written consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. Individuals under the age of 19 at the time of obtaining written consent. 2. Individuals unable to complete the questionnaire by themselves. 3. Individuals with severe nutritional imbalances, either undernutrition (BMI < 18.5 kg/m²) or overnutrition (BMI = 30.0 kg/m²) at visit 1 (screening start date). 4. Individuals with acute kidney injury at visit 1 (screening start date). 5. Individuals with severe cardiovascular or liver disease at visit 1 (screening start date). 6. Individuals with a history of infection within the past three months or currently infected at visit 1 (screening start date). 7. Individuals diagnosed with or currently undergoing treatment for malignant tumors at visit 1 (screening start date). 8. Individuals with gastrointestinal diseases (such as irritable bowel syndrome, inflammatory diseases like Crohn’s disease or ulcerative colitis, pancreatitis) within the past three months, or currently affected, or those who have had intestinal resection surgery. 9. Individuals with a history of alcohol abuse, or with psychiatric disorders such as bipolar disorder, anxiety disorders, panic disorder, somatoform disorders, personality disorders, and other psychiatric conditions. 10. Pregnant or breastfeeding women, or those intending to become pregnant. 11. Individuals with a history of hypersensitivity or allergies to the test food (diet). 12. Individuals with any other clinically significant medical conditions that the investigator deems inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Generated Subjective Global Assessment;Major Biomarker Changes(Weight, Blood pressure, lymphocyte, Hemoglobin, Blood Urea Nitrogen, Creatinine, protein, albumin, potassium, HCO3-, spot Urine Protein/Creatinine, Total Cholesterol, Triglyceride, Low-Density Lipoprotein cholesterol, High-Density Lipoprotein cholesterol) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Generated Subjective Global Assessment;Major Biomarker Changes(Weight, Blood pressure, lymphocyte, Hemoglobin, Blood Urea Nitrogen, Creatinine, protein, albumin, potassium, HCO3-, spot Urine Protein/Creatinine, Total Cholesterol, Triglyceride, Low-Density Lipoprotein cholesterol, High-Density Lipoprotein cholesterol);Nutrition Quotient;Biomarker Changes(Calcium, Phosphorus, bone specific alkaline phosphatase, intact-parathyroid hormone, 25-OH vitamin D);Changes in the Composition of the Amino Acid Panel;Clinical Laboratory Test (complete blood count, Electrolyte, Kidney, Metabolic, Chronic Kidney Disease-Mineral Bone Disorder , Urine, Nutrition);Vital Signs(systolic blood pressure, diastolic blood pressure, Pulse, Body Temperature) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoo Kyoung Park
Kyung Hee University Global Campus
Outcome results
None listed