Diabetic Nephropathies
Conditions
Brief 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).
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.
Interventions
DIETARY_SUPPLEMENTsoy protein drink
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.
DIETARY_SUPPLEMENTcasein protein drink
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.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged from 40 to 75 years and were at DN stage 4 or 5 were enrolled in this study.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| interleukin (IL)-6 | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months | inflammatory indicators |
| creatinine | 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) | 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) | 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 | 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 | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months | inflammatory indicators |
| 24-hours dietary recall | 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) | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months | renal function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months | body weight |
| blood glucose | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months | fasting plasma glucose (FPG) |
| lipid profile | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months | triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) |
| Blood pressure | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months | systolic blood pressure (SBP), diastolic blood pressure (DBP) |
Outcome results
None listed