Low-protein Formula Supplements in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: Intervention group; Other: Regular nutrition education

• Registration Number: NCT05318014
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-09-25
• Primary Completion: 2020-10-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-31
• Last Update Submitted: 2022-03-31
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention group	Regular nutrition education and supply one serving per day of 6% low protein formula.
Regular nutrition education	Regular nutrition education	Regular nutrition education

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taichung Verterans General Hospital Taichung; 🇨🇳 Taichung, Taiwan