Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

Sponsor

Taichung Veterans General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05330663

Collaborator

Fresenius Kabi Taiwan Ltd. (Industry)

Enrollment

Location

Arms

8.3

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Dietary Supplement: Low protein diet with Fresubin® renal Other: Low protein diet with normal food	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 8, 2020

Actual Primary Completion Date :

Dec 18, 2020

Actual Study Completion Date :

Dec 18, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change of body weight [baseline to week 4]
Body weight measured in kilograms

Secondary Outcome Measures

Change 3-day dietary record [baseline to week 4]
Total energy intake,3 macronutrients (carbohydrates, protein and lipids) and micronutrients
Change body composition [baseline to week 4]
Body composition measured by bioelectrical impedance analyses
Change of renal fuction [baseline to week 4]
blood urea nitrogen,serum creatinine and estimated glomerular filtration rate
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 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 waist circumference levels [baseline to week 4]
Waist circumference was measured by a tape
Change of grip strength levels [baseline to week 4]
hand grip strength was measured by grip strength device
Change of CRP [baseline to week 4]
Change of CRP in the blood
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Verterans General Hospital Taichung	Taichung	ROC	Taiwan	40705

Sponsors and Collaborators

Taichung Veterans General Hospital
Fresenius Kabi Taiwan Ltd.

Investigators

Principal Investigator: Cheng-Hsu Chen, MDPHD, Division of Nephrology in Taichung Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taichung Veterans General Hospital

ClinicalTrials.gov Identifier:

NCT05330663

Other Study ID Numbers:

SF20045B

First Posted:

Apr 15, 2022

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taichung Veterans General Hospital

Chronic kidney disease

Oral nutrition supplement

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Apr 15, 2022