Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

NCT05330663 | Completed

• 1 other identifier: SF20045B
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Disease

Keywords

Chronic kidney disease; Oral nutrition supplement

Outcome Measures

Primary Outcomes (1)

• Change of body weight

  Body weight measured in kilograms

  baseline to week 4

Secondary Outcomes (12)

• Change 3-day dietary record

  baseline to week 4

• Change body composition

  baseline to week 4

• Change of renal fuction

  baseline to week 4

• Change of electrolytes

  baseline to week 4

• Safety and compliance.

  baseline to week 4

Study Arms (2)

Intervention group

EXPERIMENTAL

Low protein diet with Fresubin® renal

Dietary Supplement: Low protein diet with Fresubin® renal

Standard of care

OTHER

Low protein diet with normal food

Other: Low protein diet with normal food

Interventions

Low protein diet with Fresubin® renal DIETARY_SUPPLEMENT

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 group

Low protein diet with normal food OTHER

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.

Standard of care

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Fresenius Kabi Taiwan Ltd.: collaborator

Study Sites (1)

Taichung Verterans General Hospital Taichung

Taichung, ROC, 40705, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Cheng-Hsu Chen, MDPHD

  Division of Nephrology in Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 15, 2022
• Study Start: April 8, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

TW (1)