Low-protein Formula Supplements in Chronic Kidney Disease

March 31, 2022 updated by: Taichung Veterans General Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Taichung Verterans General Hospital Taichung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Regular nutrition education and supply one serving per day of 6% low protein formula.
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
Placebo Comparator: Regular nutrition education
Other: Regular nutrition education
dietitian regular nutrition educataion which was following a low protein diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of muscle strength
Time Frame: Baseline to 12 weeks and 24 weeks
Hand grip strength
Baseline to 12 weeks and 24 weeks
Change of Gait speed
Time Frame: Baseline to 12 weeks and 24 weeks
Gait speed measurement
Baseline to 12 weeks and 24 weeks
Change of 5-meter distance walk
Time Frame: Baseline to 12 weeks and 24 weeks
5-meter distance walk measurement
Baseline to 12 weeks and 24 weeks
Change of nutrition status
Time Frame: Baseline to 12 weeks and 24 weeks
Mini Nutritional Assessment Short-Form score
Baseline to 12 weeks and 24 weeks
Change of body composition
Time Frame: Baseline to 12 weeks and 24 weeks
Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)
Baseline to 12 weeks and 24 weeks
Change of total energy intake
Time Frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Baseline to 12 weeks and 24 weeks
Change of protein intake
Time Frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Baseline to 12 weeks and 24 weeks
Change of carbohydrate intake
Time Frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Baseline to 12 weeks and 24 weeks
Change of fat intake
Time Frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Baseline to 12 weeks and 24 weeks
Change of micronutrients intake
Time Frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Baseline to 12 weeks and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of serum creatinine
Time Frame: Baseline to 12 weeks and 24 weeks
renal function monitoring
Baseline to 12 weeks and 24 weeks
Change of blood urea nitrogen
Time Frame: Baseline to 12 weeks and 24 weeks
renal function monitoring
Baseline to 12 weeks and 24 weeks
Change of estimated glomerular filtration rate
Time Frame: Baseline to 12 weeks and 24 weeks
renal function monitoring
Baseline to 12 weeks and 24 weeks
Change of daily protein intake.
Time Frame: Baseline to 12 weeks and 24 weeks
24-hour urine estimated protein intake with Maroni formula
Baseline to 12 weeks and 24 weeks
Change of albumin
Time Frame: Baseline to 12 weeks and 24 weeks
Change of albumin in the blood
Baseline to 12 weeks and 24 weeks
Change of sodium
Time Frame: Baseline to 12 weeks and 24 weeks
electrolyte measurement in the blood
Baseline to 12 weeks and 24 weeks
Change of potassium
Time Frame: Baseline to 12 weeks and 24 weeks
electrolyte measurement in the blood
Baseline to 12 weeks and 24 weeks
Change of calcium
Time Frame: Baseline to 12 weeks and 24 weeks
electrolyte measurement in the blood
Baseline to 12 weeks and 24 weeks
Change of phosphorus
Time Frame: Baseline to 12 weeks and 24 weeks
electrolyte measurement in the blood
Baseline to 12 weeks and 24 weeks
Change of magnesium
Time Frame: Baseline to 12 weeks and 24 weeks
electrolyte measurement in the blood
Baseline to 12 weeks and 24 weeks
Change of Hemoglobin A1c
Time Frame: Baseline to 12 weeks and 24 weeks
monitoring and diagnosis diabetes
Baseline to 12 weeks and 24 weeks
Change of blood sugar
Time Frame: Baseline to 12 weeks and 24 weeks
Blood sugar testing
Baseline to 12 weeks and 24 weeks
Change of CRP
Time Frame: Baseline to 12 weeks and 24 weeks
Change of CRP in the blood
Baseline to 12 weeks and 24 weeks
Change of red blood cell
Time Frame: Baseline to 12 weeks and 24 weeks
Routine Blood Tests in the blood
Baseline to 12 weeks and 24 weeks
Change of White blood cell
Time Frame: Baseline to 12 weeks and 24 weeks
Routine Blood Tests in the blood
Baseline to 12 weeks and 24 weeks
Change of hemoglobin
Time Frame: Baseline to 12 weeks and 24 weeks
Routine Blood Tests in the blood
Baseline to 12 weeks and 24 weeks
Change of hematocrit
Time Frame: Baseline to 12 weeks and 24 weeks
Routine Blood Tests in the blood
Baseline to 12 weeks and 24 weeks
Change of liver function
Time Frame: Baseline to 12 weeks and 24 weeks
Change of ALT and AST in the blood
Baseline to 12 weeks and 24 weeks
Change of cholesterol
Time Frame: Baseline to 12 weeks and 24 weeks
Change in lipid analysis in the blood
Baseline to 12 weeks and 24 weeks
Change of triglyceride
Time Frame: Baseline to 12 weeks and 24 weeks
Change in lipid analysis in the blood
Baseline to 12 weeks and 24 weeks
Change of LDL-cholesterol
Time Frame: Baseline to 12 weeks and 24 weeks
Change in lipid analysis in the blood
Baseline to 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taichung Veterans General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheng-Hsu Chen, MDPHD, Division of Nephrology in Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CF19237B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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