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Low-protein Formula Supplements in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intervention group
Regular nutrition education
Sponsored by
Taichung Veterans General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Oral nutrition supplement, Chronic kidney disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taichung Verterans General Hospital Taichung

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Regular nutrition education

Arm Description

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

Regular nutrition education

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 15, 2022
Last Updated
March 31, 2022
Sponsor
Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05318014
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Oral nutrition supplement, Chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Regular nutrition education and supply one serving per day of 6% low protein formula.
Arm Title
Regular nutrition education
Arm Type
Placebo Comparator
Arm Description
Regular nutrition education
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Regular nutrition education
Intervention Description
dietitian regular nutrition educataion which was following a low protein diet
Primary Outcome Measure Information:
Title
Change of muscle strength
Description
Hand grip strength
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of Gait speed
Description
Gait speed measurement
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of 5-meter distance walk
Description
5-meter distance walk measurement
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of nutrition status
Description
Mini Nutritional Assessment Short-Form score
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of body composition
Description
Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of total energy intake
Description
24-hour dietary record measurement
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of protein intake
Description
24-hour dietary record measurement
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of carbohydrate intake
Description
24-hour dietary record measurement
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of fat intake
Description
24-hour dietary record measurement
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of micronutrients intake
Description
24-hour dietary record measurement
Time Frame
Baseline to 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Change of serum creatinine
Description
renal function monitoring
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of blood urea nitrogen
Description
renal function monitoring
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of estimated glomerular filtration rate
Description
renal function monitoring
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of daily protein intake.
Description
24-hour urine estimated protein intake with Maroni formula
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of albumin
Description
Change of albumin in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of sodium
Description
electrolyte measurement in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of potassium
Description
electrolyte measurement in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of calcium
Description
electrolyte measurement in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of phosphorus
Description
electrolyte measurement in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of magnesium
Description
electrolyte measurement in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of Hemoglobin A1c
Description
monitoring and diagnosis diabetes
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of blood sugar
Description
Blood sugar testing
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of CRP
Description
Change of CRP in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of red blood cell
Description
Routine Blood Tests in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of White blood cell
Description
Routine Blood Tests in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of hemoglobin
Description
Routine Blood Tests in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of hematocrit
Description
Routine Blood Tests in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of liver function
Description
Change of ALT and AST in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of cholesterol
Description
Change in lipid analysis in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of triglyceride
Description
Change in lipid analysis in the blood
Time Frame
Baseline to 12 weeks and 24 weeks
Title
Change of LDL-cholesterol
Description
Change in lipid analysis in the blood
Time Frame
Baseline to 12 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is >65years of age. Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5. Exclusion Criteria: The physician determines that the clinical condition is unstable. Lower limb injury or severe edema. food allergies to milk, or fish There is a heart rhythm in the body and a prosthetic device. Those who are unable to complete the questionnaire due to severe cognitive impairment as determined by the physician.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Hsu Chen, MDPHD
Organizational Affiliation
Division of Nephrology in Taichung Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taichung Verterans General Hospital Taichung
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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Low-protein Formula Supplements in Chronic Kidney Disease

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