Low-protein Formula Supplements in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318014
• Other study ID #: CF19237B
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Other:
• Regular nutrition education
dietitian regular nutrition educataion which was following a low protein diet

Locations

Country	Name	City	State
Taiwan	Taichung Verterans General Hospital Taichung	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of muscle strength	Hand grip strength	Baseline to 12 weeks and 24 weeks
Primary	Change of Gait speed	Gait speed measurement	Baseline to 12 weeks and 24 weeks
Primary	Change of 5-meter distance walk	5-meter distance walk measurement	Baseline to 12 weeks and 24 weeks
Primary	Change of nutrition status	Mini Nutritional Assessment Short-Form score	Baseline to 12 weeks and 24 weeks
Primary	Change of body composition	Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)	Baseline to 12 weeks and 24 weeks
Primary	Change of total energy intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Primary	Change of protein intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Primary	Change of carbohydrate intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Primary	Change of fat intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Primary	Change of micronutrients intake	24-hour dietary record measurement	Baseline to 12 weeks and 24 weeks
Secondary	Change of serum creatinine	renal function monitoring	Baseline to 12 weeks and 24 weeks
Secondary	Change of blood urea nitrogen	renal function monitoring	Baseline to 12 weeks and 24 weeks
Secondary	Change of estimated glomerular filtration rate	renal function monitoring	Baseline to 12 weeks and 24 weeks
Secondary	Change of daily protein intake.	24-hour urine estimated protein intake with Maroni formula	Baseline to 12 weeks and 24 weeks
Secondary	Change of albumin	Change of albumin in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of sodium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of potassium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of calcium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of phosphorus	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of magnesium	electrolyte measurement in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of Hemoglobin A1c	monitoring and diagnosis diabetes	Baseline to 12 weeks and 24 weeks
Secondary	Change of blood sugar	Blood sugar testing	Baseline to 12 weeks and 24 weeks
Secondary	Change of CRP	Change of CRP in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of red blood cell	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of White blood cell	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of hemoglobin	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of hematocrit	Routine Blood Tests in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of liver function	Change of ALT and AST in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of cholesterol	Change in lipid analysis in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of triglyceride	Change in lipid analysis in the blood	Baseline to 12 weeks and 24 weeks
Secondary	Change of LDL-cholesterol	Change in lipid analysis in the blood	Baseline to 12 weeks and 24 weeks