Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05330663
• Other study ID #: SF20045B
• Status: Completed
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: April 2022
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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:
• 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.

Locations

Country	Name	City	State
Taiwan	Taichung Verterans General Hospital Taichung	Taichung	ROC

Sponsors (2)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital	Fresenius Kabi Taiwan Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

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