Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

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

Detailed Description
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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.

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: Low protein diet with Fresubin® renal
* Other: Low protein diet with normal food


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Low protein diet with Fresubin® renal | Dietary Supplement: Low protein diet with Fresubin® renal<br>* 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.<br>|
| Other: Standard of care<br>Low protein diet with normal food | Other: Low protein diet with normal food<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Oral nutrition supplement