Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Low protein diet with Fresubin® renal; Other: Low protein diet with normal food

• Registration Number: NCT05330663
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2020-04-08
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Study First Submitted: 2022-03-26
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-08
• Last Update Submitted: 2022-04-08
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Low protein diet with Fresubin® renal	Low protein diet with Fresubin® renal
Standard of care	Low protein diet with normal food	Low protein diet with normal food

Primary Outcome Measures

Name	Time	Method
Change of body weight	baseline to week 4	Body weight measured in kilograms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Verterans General Hospital Taichung; 🇨🇳 Taichung, ROC, Taiwan