NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease | Crick | Crick

Low-protein Formula Supplements in Chronic Kidney Disease

N/ACompletedNCT05318014

Taichung Veterans General Hospital95 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

95

Conditions

Chronic Kidney Disease

Interventions

Intervention groupDIETARY_SUPPLEMENT

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

Regular nutrition educationOTHER

dietitian regular nutrition educataion which was following a low protein diet

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taichung Verterans General Hospital Taichung

Taichung, Taiwan

Outcomes

Primary Outcomes

Change of muscle strength

Hand grip strength

Time frame: Baseline to 12 weeks and 24 weeks

Change of Gait speed

Gait speed measurement

Time frame: Baseline to 12 weeks and 24 weeks

Change of 5-meter distance walk

5-meter distance walk measurement

Time frame: Baseline to 12 weeks and 24 weeks

Change of nutrition status

Mini Nutritional Assessment Short-Form score

Time frame: Baseline to 12 weeks and 24 weeks

Change of body composition

Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)

Time frame: Baseline to 12 weeks and 24 weeks

Change of total energy intake

24-hour dietary record measurement

Time frame: Baseline to 12 weeks and 24 weeks

Change of protein intake

24-hour dietary record measurement

Time frame: Baseline to 12 weeks and 24 weeks

Change of carbohydrate intake

24-hour dietary record measurement

Time frame: Baseline to 12 weeks and 24 weeks

Change of fat intake

24-hour dietary record measurement

Time frame: Baseline to 12 weeks and 24 weeks

Data from ClinicalTrials.gov

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Secondary Outcomes

Change of serum creatinine

renal function monitoring

Time frame: Baseline to 12 weeks and 24 weeks

Change of blood urea nitrogen

renal function monitoring

Time frame: Baseline to 12 weeks and 24 weeks

Change of estimated glomerular filtration rate

renal function monitoring

Time frame: Baseline to 12 weeks and 24 weeks

Change of daily protein intake.

24-hour urine estimated protein intake with Maroni formula

Time frame: Baseline to 12 weeks and 24 weeks

Change of albumin

Change of albumin in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of sodium

electrolyte measurement in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of potassium

electrolyte measurement in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of calcium

electrolyte measurement in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of phosphorus

electrolyte measurement in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of magnesium

electrolyte measurement in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of Hemoglobin A1c

monitoring and diagnosis diabetes

Time frame: Baseline to 12 weeks and 24 weeks

Change of blood sugar

Blood sugar testing

Time frame: Baseline to 12 weeks and 24 weeks

Change of CRP

Change of CRP in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of red blood cell

Routine Blood Tests in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of White blood cell

Routine Blood Tests in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of hemoglobin

Routine Blood Tests in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of hematocrit

Routine Blood Tests in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of liver function

Change of ALT and AST in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of cholesterol

Change in lipid analysis in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of triglyceride

Change in lipid analysis in the blood

Time frame: Baseline to 12 weeks and 24 weeks

Change of LDL-cholesterol

Change in lipid analysis in the blood

Time frame: Baseline to 12 weeks and 24 weeks