Back to results

Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

Primary Purpose

Chronic Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Low protein diet with Fresubin® renal

Low protein diet with normal food

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Oral nutrition supplement

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Taichung Verterans General Hospital Taichung

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Standard of care

Arm Description

Low protein diet with Fresubin® renal

Low protein diet with normal food

Outcomes

Primary Outcome Measures

Change of body weight

Body weight measured in kilograms

Secondary Outcome Measures

Change 3-day dietary record

Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients

Change body composition

Body composition measured by bioelectrical impedance analyses

Change of renal fuction

blood urea nitrogen,serum creatinine and estimated glomerular filtration rate

Change of electrolytes

Sodium,potassium,calciam,phosphorus and magnesium in the blood

Safety and compliance.

gastrointestinal symptoms measured by questionnaire

Change in lipid analysis

Change of cholesterol ,triglyceride ,and LDL-cholesterol in the blood

Change of Body Mass Index (BMI) levels

BMI was calculate by body weight (kg) divided by the square of the height (m^2)

Change of waist circumference levels

Waist circumference was measured by a tape

Change of grip strength levels

hand grip strength was measured by grip strength device

Change of CRP

Change of CRP in the blood

Change of nutrition status in blood test

Serum albumin, pre-albumin, total protein, uric acid

Change of daily protein intake

24-hour urine estimated protein intake with Maroni formula

Full Information

NCT ID

NCT05330663

First Posted

March 26, 2022

Last Updated

April 8, 2022

Sponsor

Taichung Veterans General Hospital

Collaborators

Fresenius Kabi Taiwan Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05330663

Brief Title

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

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 8, 2020 (Actual)

Primary Completion Date

December 18, 2020 (Actual)

Study Completion Date

December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taichung Veterans General Hospital

Collaborators

Fresenius Kabi Taiwan Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease

Keywords

Chronic kidney disease, Oral nutrition supplement

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Low protein diet with Fresubin® renal

Arm Title

Standard of care

Arm Type

Other

Arm Description

Low protein diet with normal food

Intervention Type

Dietary Supplement

Intervention Name(s)

Low protein diet with Fresubin® renal

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Low protein diet with normal food

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of body weight

Description

Body weight measured in kilograms

Time Frame

baseline to week 4

Secondary Outcome Measure Information:

Title

Change 3-day dietary record

Description

Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients

Time Frame

baseline to week 4

Title

Change body composition

Description

Body composition measured by bioelectrical impedance analyses

Time Frame

baseline to week 4

Title

Change of renal fuction

Description

blood urea nitrogen,serum creatinine and estimated glomerular filtration rate

Time Frame

baseline to week 4

Title

Change of electrolytes

Description

Sodium,potassium,calciam,phosphorus and magnesium in the blood

Time Frame

baseline to week 4

Title

Safety and compliance.

Description

gastrointestinal symptoms measured by questionnaire

Time Frame

baseline to week 4

Title

Change in lipid analysis

Description

Change of cholesterol ,triglyceride ,and LDL-cholesterol in the blood

Time Frame

baseline to week 4

Title

Change of Body Mass Index (BMI) levels

Description

BMI was calculate by body weight (kg) divided by the square of the height (m^2)

Time Frame

baseline to week 4

Title

Change of waist circumference levels

Description

Waist circumference was measured by a tape

Time Frame

baseline to week 4

Title

Change of grip strength levels

Description

hand grip strength was measured by grip strength device

Time Frame

baseline to week 4

Title

Change of CRP

Description

Change of CRP in the blood

Time Frame

baseline to week 4

Title

Change of nutrition status in blood test

Description

Serum albumin, pre-albumin, total protein, uric acid

Time Frame

baseline to week 4

Title

Change of daily protein intake

Description

24-hour urine estimated protein intake with Maroni formula

Time Frame

baseline to week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cheng-Hsu Chen, MDPHD

Organizational Affiliation

Division of Nephrology in Taichung Veterans General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taichung Verterans General Hospital Taichung

City

Taichung

State/Province

ROC

ZIP/Postal Code

40705

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

We'll reach out to this number within 24 hrs