Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

High Energy Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

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

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: Low protein diet with Fresubin® renal; Other: Low protein diet with normal food

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • ROC
    • Taichung, ROC, Taiwan, 40705
      • Taichung Verterans General Hospital Taichung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Low protein diet with Fresubin® renal	Dietary supplement: Low protein diet with Fresubin® renal; Low protein diet with Fresubin® renal Dosage: 1 bottle per day as a replacement for one regular meal. All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight.
Other: Standard of care; Low protein diet with normal food	Other: Low protein diet with normal food; All patients will get individualized dietary counseling aimed at achieving a protein intake of 0.6-0.8 g/kg actual body weight/day and an energy intake of 30-35 kcal/kg actual body weight/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of body weight	Body weight measured in kilograms	baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change 3-day dietary record	Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients	baseline to week 4
Change body composition	Body composition measured by bioelectrical impedance analyses	baseline to week 4
Change of renal fuction	blood urea nitrogen,serum creatinine and estimated glomerular filtration rate	baseline to week 4
Change of electrolytes	Sodium,potassium,calciam,phosphorus and magnesium in the blood	baseline to week 4
Safety and compliance.	gastrointestinal symptoms measured by questionnaire	baseline to week 4
Change in lipid analysis	Change of cholesterol ,triglyceride ,and LDL-cholesterol in the blood	baseline to week 4
Change of Body Mass Index (BMI) levels	BMI was calculate by body weight (kg) divided by the square of the height (m^2)	baseline to week 4
Change of waist circumference levels	Waist circumference was measured by a tape	baseline to week 4
Change of grip strength levels	hand grip strength was measured by grip strength device	baseline to week 4
Change of CRP	Change of CRP in the blood	baseline to week 4
Change of nutrition status in blood test	Serum albumin, pre-albumin, total protein, uric acid	baseline to week 4
Change of daily protein intake	24-hour urine estimated protein intake with Maroni formula	baseline to week 4

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Collaborators: Fresenius Kabi Taiwan Ltd.
• Investigators: Principal Investigator: Cheng-Hsu Chen, MDPHD, Division of Nephrology in Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Actual): December 18, 2020
• Study Completion (Actual): December 18, 2020

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Oral nutrition supplement
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: SF20045B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No