Diabetic NephropathiesNCT05840796
To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients
A study testing soy protein drink and casein protein drink in people with Diabetic Nephropathies, run by Taipei Medical University.
Trial summary
This study investigated the beneficial effects of soybean on the renal function, oxidative stress, and inflammatory responses in patients with end-stage diabetic nephropathy (DN). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- soy protein drink and casein protein drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 28 Feb 2015
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged from 40 to 75 years and were at DN stage 4 or 5 were enrolled in this study.
Who cannot join
- The exclusion criteria were having hemodialysis, lactose intolerance, gastrointestinal (GI) tract dysfunction, liver disease, acute metabolic acidosis or ketoacidosis, in acute infection, severe dehydration, alcohol abuse, addictive drug abuse, cancer in recent 5 years, being involved in another trial in past 1 month, had operation in the past 4 months, or had compliance lower than 90% in the first month of study.
About this study
This study investigated the beneficial effects of soybean on the renal function, oxidative stress, and inflammatory responses in patients with end-stage diabetic nephropathy (DN).
Read the detailed description
DN outpatients were recruited from Tung's Taichung MetroHarbor Hospital (Taichung City, Taiwan). They were randomly separated into two groups; one group was given soy protein drink and the other group was given casein drink for 4 months. The blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the end of the study.
- Conditions
- Diabetic Nephropathies
- Being tested
- soy protein drink, casein protein drink
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy protein drinkDietary supplement
The calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula.
Each participant had two packs of nutrition supplement per day for 4months. The 24-h dietary record, blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the 4th month of the study.
The participants were followed up until the 7th month of the study.
casein protein drinkDietary supplement
The calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula.
Each participant had two packs of nutrition supplement per day for 4 months. The 24-h dietary record, blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the 4th month of the study.
The participants were followed up until the 7th month of the study.
| Study group | Role | What they receive |
|---|---|---|
| soy protein drink | Experimental | The calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula.
Each participant had two packs of nutrition supplement per day. Receives: Dietary Supplement: soy protein drink |
| casein protein drink | Other | The calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula.
Each participant had two packs of nutrition supplement per day. Receives: Dietary Supplement: casein protein drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hours dietary recall
Estimated by registered dietitian to understand calories, protein and nutrients intake..
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
estimated glomerular filtration rate (eGFR)
renal function
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
creatinine
renal function
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
plasma malondialdehyde (MDA)
Antioxidative statement-lipid peroxidation
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
high-sensitivity C-reactive protein (hs-CRP)
inflammatory indicators
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
soluble intercellular adhesion molecule (sICAM)-1
inflammatory indicators
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
soluble vascular cell adhesion molecule (sVICAM)-1
inflammatory indicators
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
interleukin (IL)-6
inflammatory indicators
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Secondary outcomes (4)
Blood pressure
systolic blood pressure (SBP), diastolic blood pressure (DBP)
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
body weight
body weight
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
blood glucose
fasting plasma glucose (FPG)
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
lipid profile
triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)
Measured: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Apr 2014
- Primary completion28 Feb 2015
- Study completion28 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840796
- Sponsor's protocol ID
- TTMHH-103006
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients
- ClinicalTrials.gov ID
- NCT05840796
- Acronym / sponsor ID
- TTMHH-103006
- Conditions
- Diabetic Nephropathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 28 Feb 2015 (actual)
- Study completion
- 28 Feb 2015 (actual)
- First posted
- 3 May 2023 (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.
This study investigated the beneficial effects of soybean on the renal function, oxidative stress, and inflammatory responses in patients with end-stage diabetic nephropathy (DN).
Detailed description
DN outpatients were recruited from Tung's Taichung MetroHarbor Hospital (Taichung City, Taiwan). They were randomly separated into two groups; one group was given soy protein drink and the other group was given casein drink for 4 months. The blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soy protein drink | Experimental | Dietary Supplement: soy protein drinkThe calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula. Each participant had two packs of nutrition supplement per day. |
| casein protein drink | Other | Dietary Supplement: casein protein drinkThe calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula. Each participant had two packs of nutrition supplement per day. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants aged from 40 to 75 years and were at DN stage 4 or 5 were enrolled in this study.
Key exclusion criteria (1 listed)
- The exclusion criteria were having hemodialysis, lactose intolerance, gastrointestinal (GI) tract dysfunction, liver disease, acute metabolic acidosis or ketoacidosis, in acute infection, severe dehydration, alcohol abuse, addictive drug abuse, cancer in recent 5 years, being involved in another trial in past 1 month, had operation in the past 4 months, or had compliance lower than 90% in the first month of study.
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 |
|---|---|---|
| soy protein drinkThe calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula. Each participant had two packs of nutrition supplement per day for 4months. The 24-h dietary record, blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the 4th month of the study. The participants were followed up until the 7th month of the study. | Dietary supplement | soy protein drink |
| casein protein drinkThe calories oral nutrition supplements were 100 kcal, which included 8.4g of protein and phosphorous was excluded in two oral nutrition supplements formula. Each participant had two packs of nutrition supplement per day for 4 months. The 24-h dietary record, blood pressure, plasma glucose, lipid profile, renal function (estimated glomerular filtration rate, eGFR), inflammatory factor levels were analyzed at the baseline and at the 4th month of the study. The participants were followed up until the 7th month of the study. | Dietary supplement | casein protein drink |
Primary outcome
24-hours dietary recall
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Estimated by registered dietitian to understand calories, protein and nutrients intake..
estimated glomerular filtration rate (eGFR)
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
renal function
creatinine
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
renal function
plasma malondialdehyde (MDA)
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Antioxidative statement-lipid peroxidation
high-sensitivity C-reactive protein (hs-CRP)
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
soluble intercellular adhesion molecule (sICAM)-1
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
soluble vascular cell adhesion molecule (sVICAM)-1
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
interleukin (IL)-6
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
inflammatory indicators
4 secondary outcomes
Blood pressure
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
body weight
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
blood glucose
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
lipid profile
Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
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 3 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing soy protein drink and casein protein drink in people with Diabetic Nephropathies, run by Taipei Medical University.
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 1 inclusion and 1 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
24-hours dietary recall (time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.