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Completed

NCT Number: NCT05318014

Low-protein Formula Supplements in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Verterans General Hospital Taichung

Taichung, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

Dietary 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 education

Other

dietitian regular nutrition educataion which was following a low protein diet

Primary outcomes

  1. Change of muscle strength

    Time frame: Baseline to 12 weeks and 24 weeks

    Hand grip strength

  2. Change of Gait speed

    Time frame: Baseline to 12 weeks and 24 weeks

    Gait speed measurement

  3. Change of 5-meter distance walk

    Time frame: Baseline to 12 weeks and 24 weeks

    5-meter distance walk measurement

  4. Change of nutrition status

    Time frame: Baseline to 12 weeks and 24 weeks

    Mini Nutritional Assessment Short-Form score

  5. Change of body composition

    Time frame: Baseline to 12 weeks and 24 weeks

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

  6. Change of total energy intake

    Time frame: Baseline to 12 weeks and 24 weeks

    24-hour dietary record measurement

  7. Change of protein intake

    Time frame: Baseline to 12 weeks and 24 weeks

    24-hour dietary record measurement

  8. Change of carbohydrate intake

    Time frame: Baseline to 12 weeks and 24 weeks

    24-hour dietary record measurement

  9. Change of fat intake

    Time frame: Baseline to 12 weeks and 24 weeks

    24-hour dietary record measurement

  10. Change of micronutrients intake

    Time frame: Baseline to 12 weeks and 24 weeks

    24-hour dietary record measurement

Secondary outcomes

  1. Change of serum creatinine

    Time frame: Baseline to 12 weeks and 24 weeks

    renal function monitoring

  2. Change of blood urea nitrogen

    Time frame: Baseline to 12 weeks and 24 weeks

    renal function monitoring

  3. Change of estimated glomerular filtration rate

    Time frame: Baseline to 12 weeks and 24 weeks

    renal function monitoring

  4. Change of daily protein intake.

    Time frame: Baseline to 12 weeks and 24 weeks

    24-hour urine estimated protein intake with Maroni formula

  5. Change of albumin

    Time frame: Baseline to 12 weeks and 24 weeks

    Change of albumin in the blood

  6. Change of sodium

    Time frame: Baseline to 12 weeks and 24 weeks

    electrolyte measurement in the blood

  7. Change of potassium

    Time frame: Baseline to 12 weeks and 24 weeks

    electrolyte measurement in the blood

  8. Change of calcium

    Time frame: Baseline to 12 weeks and 24 weeks

    electrolyte measurement in the blood

  9. Change of phosphorus

    Time frame: Baseline to 12 weeks and 24 weeks

    electrolyte measurement in the blood

  10. Change of magnesium

    Time frame: Baseline to 12 weeks and 24 weeks

    electrolyte measurement in the blood

  11. Change of Hemoglobin A1c

    Time frame: Baseline to 12 weeks and 24 weeks

    monitoring and diagnosis diabetes

  12. Change of blood sugar

    Time frame: Baseline to 12 weeks and 24 weeks

    Blood sugar testing

  13. Change of CRP

    Time frame: Baseline to 12 weeks and 24 weeks

    Change of CRP in the blood

  14. Change of red blood cell

    Time frame: Baseline to 12 weeks and 24 weeks

    Routine Blood Tests in the blood

  15. Change of White blood cell

    Time frame: Baseline to 12 weeks and 24 weeks

    Routine Blood Tests in the blood

  16. Change of hemoglobin

    Time frame: Baseline to 12 weeks and 24 weeks

    Routine Blood Tests in the blood

  17. Change of hematocrit

    Time frame: Baseline to 12 weeks and 24 weeks

    Routine Blood Tests in the blood

  18. Change of liver function

    Time frame: Baseline to 12 weeks and 24 weeks

    Change of ALT and AST in the blood

  19. Change of cholesterol

    Time frame: Baseline to 12 weeks and 24 weeks

    Change in lipid analysis in the blood

  20. Change of triglyceride

    Time frame: Baseline to 12 weeks and 24 weeks

    Change in lipid analysis in the blood

  21. Change of LDL-cholesterol

    Time frame: Baseline to 12 weeks and 24 weeks

    Change in lipid analysis in the blood

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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