Low-protein Formula Supplements in Chronic Kidney Disease

Effect of Low-protein Formula Nutritional Supplements on Renal Function Progression, Muscle Mass and Physical Activity With Chronic Kidney Disease

Prospective randomized contorl study.Comparing clinical outcome between chronic kidney disease who were prescribed 6% low-protein nutrition supplement along with dietatian regular nutrition education and those without oral nutrition supplement.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: Intervention group; Other: Regular nutrition education

Detailed Description

Past studies have shown that supplementation with low-protein nutritional formulas helps to increase compliance with low-protein diet control, but few studies have explored low-protein nutritional formulas supplementing the calories chronic kidney disease patient need, and nutritional supplements rich in ω-3 fatty acids, vitamin D and essential amino acid having effect in chronic renal function and changes in muscle mass, strength, and mobility. The propose of this study that low protein supplement may help maintain renal function or delay deterioration of renal function, or may reduce the risk of malnutrition and further improve muscle strength and mobility or quality of life.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Taichung Verterans General Hospital Taichung

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is >65years of age.
2. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.

Exclusion Criteria:

1. The physician determines that the clinical condition is unstable.
2. Lower limb injury or severe edema.
3. food allergies to milk, or fish
4. There is a heart rhythm in the body and a prosthetic device.
5. Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Regular nutrition education and supply one serving per day of 6% low protein formula.	Dietary supplement: Intervention group; dietitian regular nutrition education which was following a low protein diet and supply one serving per day of 6 % low protein formula (200mL,2kcal/ml) for 24 weeks
Placebo Comparator: Regular nutrition education	Other: Regular nutrition education; dietitian regular nutrition educataion which was following a low protein diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of muscle strength	Hand grip strength	Baseline to 12 weeks and 24 weeks
Change of Gait speed	Gait speed measurement	Baseline to 12 weeks and 24 weeks
Change of 5-meter distance walk	5-meter distance walk measurement	Baseline to 12 weeks and 24 weeks
Change of nutrition status	Mini Nutritional Assessment Short-Form score	Baseline to 12 weeks and 24 weeks
Change of body composition	Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)	Baseline to 12 weeks and 24 weeks
Change of total energy intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Change of protein intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Change of carbohydrate intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Change of fat intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Change of micronutrients intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of serum creatinine	renal function monitoring	Baseline to 12 weeks and 24 weeks
Change of blood urea nitrogen	renal function monitoring	Baseline to 12 weeks and 24 weeks
Change of estimated glomerular filtration rate	renal function monitoring	Baseline to 12 weeks and 24 weeks
Change of daily protein intake.	24-hour urine estimated protein intake with Maroni formula	Baseline to 12 weeks and 24 weeks
Change of albumin	Change of albumin in the blood	Baseline to 12 weeks and 24 weeks
Change of sodium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Change of potassium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Change of calcium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Change of phosphorus	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Change of magnesium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Change of Hemoglobin A1c	monitoring and diagnosis diabetes	Baseline to 12 weeks and 24 weeks
Change of blood sugar	Blood sugar testing	Baseline to 12 weeks and 24 weeks
Change of CRP	Change of CRP in the blood	Baseline to 12 weeks and 24 weeks
Change of red blood cell	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Change of White blood cell	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Change of hemoglobin	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Change of hematocrit	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Change of liver function	Change of ALT and AST in the blood	Baseline to 12 weeks and 24 weeks
Change of cholesterol	Change in lipid analysis in the blood	Baseline to 12 weeks and 24 weeks
Change of triglyceride	Change in lipid analysis in the blood	Baseline to 12 weeks and 24 weeks
Change of LDL-cholesterol	Change in lipid analysis in the blood	Baseline to 12 weeks and 24 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Oral nutrition supplement
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: CF19237B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No