Chronic Kidney DiseaseNCT05318014
Low-protein Formula Supplements in Chronic Kidney Disease
A study testing Intervention group and Regular nutrition education in people with Chronic Kidney Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Intervention group and Regular nutrition education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject is >65years of age.
- Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Intervention group, Regular nutrition education
- Keywords
- Oral nutrition supplement, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Regular nutrition education and supply one serving per day of 6% low protein formula. Receives: Dietary Supplement: Intervention group |
| Regular nutrition education | Placebo comparator | Regular nutrition education Receives: Other: Regular nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle strength
Hand grip strength
Measured: Baseline to 12 weeks and 24 weeks
Change of Gait speed
Gait speed measurement
Measured: Baseline to 12 weeks and 24 weeks
Change of 5-meter distance walk
5-meter distance walk measurement
Measured: Baseline to 12 weeks and 24 weeks
Change of nutrition status
Mini Nutritional Assessment Short-Form score
Measured: Baseline to 12 weeks and 24 weeks
Change of body composition
Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)
Measured: Baseline to 12 weeks and 24 weeks
Change of total energy intake
24-hour dietary record measurement
Measured: Baseline to 12 weeks and 24 weeks
Change of protein intake
24-hour dietary record measurement
Measured: Baseline to 12 weeks and 24 weeks
Change of carbohydrate intake
24-hour dietary record measurement
Measured: Baseline to 12 weeks and 24 weeks
Change of fat intake
24-hour dietary record measurement
Measured: Baseline to 12 weeks and 24 weeks
Change of micronutrients intake
24-hour dietary record measurement
Measured: Baseline to 12 weeks and 24 weeks
Secondary outcomes (21)
Change of serum creatinine
renal function monitoring
Measured: Baseline to 12 weeks and 24 weeks
Change of blood urea nitrogen
renal function monitoring
Measured: Baseline to 12 weeks and 24 weeks
Change of estimated glomerular filtration rate
renal function monitoring
Measured: Baseline to 12 weeks and 24 weeks
Change of daily protein intake.
24-hour urine estimated protein intake with Maroni formula
Measured: Baseline to 12 weeks and 24 weeks
Change of albumin
Change of albumin in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of sodium
electrolyte measurement in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of potassium
electrolyte measurement in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of calcium
electrolyte measurement in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of phosphorus
electrolyte measurement in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of magnesium
electrolyte measurement in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of Hemoglobin A1c
monitoring and diagnosis diabetes
Measured: Baseline to 12 weeks and 24 weeks
Change of blood sugar
Blood sugar testing
Measured: Baseline to 12 weeks and 24 weeks
Change of CRP
Change of CRP in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of red blood cell
Routine Blood Tests in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of White blood cell
Routine Blood Tests in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of hemoglobin
Routine Blood Tests in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of hematocrit
Routine Blood Tests in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of liver function
Change of ALT and AST in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of cholesterol
Change in lipid analysis in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of triglyceride
Change in lipid analysis in the blood
Measured: Baseline to 12 weeks and 24 weeks
Change of LDL-cholesterol
Change in lipid analysis in the blood
Measured: Baseline to 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start25 Sep 2019
- Primary completion31 Oct 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Hsu Chen, MDPHD, Principal investigator, Division of Nephrology in Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318014
- Sponsor's protocol ID
- CF19237B
- Status last verified
- Mar 2022
- First submitted
- 15 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang WC, Hsieh HM, Chen JP, Liu LC, Chen CH. Effects of a low-protein nutritional formula with dietary counseling in older adults with chronic kidney disease stages 3-5: a randomized controlled trial. BMC Nephrol. 2023 Dec 14;24(1):372. doi: 10.1186/s12882-023-03423-8.
PubMed 38097963
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-protein Formula Nutritional Supplements on Renal Function Progression, Muscle Mass and Physical Activity With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05318014
- Acronym / sponsor ID
- CF19237B
- Conditions
- Chronic Kidney Disease
- Keywords
- Oral nutrition supplement, Chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Intervention groupRegular nutrition education and supply one serving per day of 6% low protein formula. |
| Regular nutrition education | Placebo comparator | Other: Regular nutrition educationRegular nutrition education |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Subject is >65years of age.
- Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3 to 5.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupdietitian 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 | Dietary supplement | Intervention group |
| Regular nutrition educationdietitian regular nutrition educataion which was following a low protein diet | Other | Regular nutrition education |
Primary outcome
Change of muscle strength
Time frame: Baseline to 12 weeks and 24 weeks
Hand grip strength
Change of Gait speed
Time frame: Baseline to 12 weeks and 24 weeks
Gait speed measurement
Change of 5-meter distance walk
Time frame: Baseline to 12 weeks and 24 weeks
5-meter distance walk measurement
Change of nutrition status
Time frame: Baseline to 12 weeks and 24 weeks
Mini Nutritional Assessment Short-Form score
Change of body composition
Time frame: Baseline to 12 weeks and 24 weeks
Using bioelectrical impedance analysis(BIA, Tanita MC-780, Japan)
Change of total energy intake
Time frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of protein intake
Time frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of carbohydrate intake
Time frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of fat intake
Time frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
Change of micronutrients intake
Time frame: Baseline to 12 weeks and 24 weeks
24-hour dietary record measurement
21 secondary outcomes
Change of serum creatinine
Time frame: Baseline to 12 weeks and 24 weeks
Change of blood urea nitrogen
Time frame: Baseline to 12 weeks and 24 weeks
Change of estimated glomerular filtration rate
Time frame: Baseline to 12 weeks and 24 weeks
Change of daily protein intake.
Time frame: Baseline to 12 weeks and 24 weeks
Change of albumin
Time frame: Baseline to 12 weeks and 24 weeks
Change of sodium
Time frame: Baseline to 12 weeks and 24 weeks
Change of potassium
Time frame: Baseline to 12 weeks and 24 weeks
Change of calcium
Time frame: Baseline to 12 weeks and 24 weeks
Change of phosphorus
Time frame: Baseline to 12 weeks and 24 weeks
Change of magnesium
Time frame: Baseline to 12 weeks and 24 weeks
Change of Hemoglobin A1c
Time frame: Baseline to 12 weeks and 24 weeks
Change of blood sugar
Time frame: Baseline to 12 weeks and 24 weeks
Change of CRP
Time frame: Baseline to 12 weeks and 24 weeks
Change of red blood cell
Time frame: Baseline to 12 weeks and 24 weeks
Change of White blood cell
Time frame: Baseline to 12 weeks and 24 weeks
Change of hemoglobin
Time frame: Baseline to 12 weeks and 24 weeks
Change of hematocrit
Time frame: Baseline to 12 weeks and 24 weeks
Change of liver function
Time frame: Baseline to 12 weeks and 24 weeks
Change of cholesterol
Time frame: Baseline to 12 weeks and 24 weeks
Change of triglyceride
Time frame: Baseline to 12 weeks and 24 weeks
Change of LDL-cholesterol
Time frame: Baseline to 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 38097963Yang WC, Hsieh HM, Chen JP, Liu LC, Chen CH. Effects of a low-protein nutritional formula with dietary counseling in older adults with chronic kidney disease stages 3-5: a randomized controlled trial. BMC Nephrol. 2023 Dec 14;24(1):372. doi: 10.1186/s12882-023-03423-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Hsu Chen, MDPHD principal investigator
Division of Nephrology in Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group and Regular nutrition education in people with Chronic Kidney Disease, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of muscle strength (time frame: Baseline to 12 weeks and 24 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.