Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

Taichung Veterans General Hospital

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Low protein diet with normal food; Dietary Supplement: Low protein diet with Fresubin® renal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05330663

SF20045B

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Intervention group

Experimental group

Description:

Low protein diet with Fresubin® renal

Treatment:

Dietary Supplement: Low protein diet with Fresubin® renal

Standard of care

Other group

Description:

Low protein diet with normal food

Treatment:

Other: Low protein diet with normal food