Clinical trial NCT05318014: Low-protein Formula Supplements in Chronic Kidney Disease
Official title: Effect of Low-protein Formula Nutritional Supplements on Renal Function Progression, Muscle Mass and Physical Activity With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Oral nutrition supplement
Chronic kidney disease
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 95
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of muscle strength
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of Gait speed
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of 5-meter distance walk
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of nutrition status
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of body composition
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of total energy intake
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of protein intake
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of carbohydrate intake
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of fat intake
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of micronutrients intake
timeFrame: Baseline to 12 weeks and 24 weeks
Secondary outcomes:
measure: Change of serum creatinine
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of blood urea nitrogen
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of estimated glomerular filtration rate
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of daily protein intake.
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of albumin
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of sodium
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of potassium
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of calcium
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of phosphorus
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of magnesium
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of Hemoglobin A1c
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of blood sugar
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of CRP
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of red blood cell
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of White blood cell
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of hemoglobin
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of hematocrit
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of liver function
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of cholesterol
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of triglyceride
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Change of LDL-cholesterol
timeFrame: Baseline to 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Verterans General Hospital Taichung
Study officials:
affiliation: Division of Nephrology in Taichung Veterans General Hospital
name: Cheng-Hsu Chen, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: