Clinical trial NCT05330663: Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
Official title: High Energy Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
Oral nutrition supplement
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi Taiwan Ltd.
First posted: 2022-04-15
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.

Detailed description: Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients

This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.

Eligibility criteria: Inclusion criteria:

* Chronic kidney disease stage 4-5 (eGFR \<30 mL/min/1.73m2)
* Age: 20-80 years
* Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
* Written informed consent

Exclusion criteria:

* Dialysis or planned start of dialysis within next 3 months
* Patients awaiting kidney transplantation
* BMI \<18 and \>30 kg/m2
* Malnourished patients with albumin levels less than 3 g/dL who need additional supplementation of calories and nutrients
* Severe liver disease, malignant disease, infectious disease
* Existing gastrointestinal diseases or pathological findings, which do not allow EN, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical GI resection
* Severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day)
* Dysphagia or high aspiration risk
* Relevant CNS and/or psychiatric disorders
* Known allergic reaction or intolerance to any of the ingredients of the study product
* Planned surgery or hospitalization during study period
* Suspicion of drug abuse
* Patients unable to follow study instructions or keeping a dietary diary
* Pregnant or lactating women
* Participation in another clinical trial with an investigational product within 30 days prior to start of study or during the study

Primary outcomes:
measure: Change of body weight
timeFrame: baseline to week 4
Secondary outcomes:
measure: Change 3-day dietary record
timeFrame: baseline to week 4
measure: Change body composition
timeFrame: baseline to week 4
measure: Change of renal fuction
timeFrame: baseline to week 4
measure: Change of electrolytes
timeFrame: baseline to week 4
measure: Safety and compliance.
timeFrame: baseline to week 4
measure: Change in lipid analysis
timeFrame: baseline to week 4
measure: Change of Body Mass Index (BMI) levels
timeFrame: baseline to week 4
measure: Change of waist circumference levels
timeFrame: baseline to week 4
measure: Change of grip strength levels
timeFrame: baseline to week 4
measure: Change of CRP
timeFrame: baseline to week 4
measure: Change of nutrition status in blood test
timeFrame: baseline to week 4
measure: Change of daily protein intake
timeFrame: baseline to week 4
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Verterans General Hospital Taichung
state: ROC
Study officials:
affiliation: Division of Nephrology in Taichung Veterans General Hospital
name: Cheng-Hsu Chen, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: