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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy protein drink | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hours dietary recall | Estimated by registered dietitian to understand calories, protein and nutrients intake.. | 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 | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months |
| creatinine | renal function | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | systolic blood pressure (SBP), diastolic blood pressure (DBP) | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months |
| body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| casein protein drink | Dietary 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. |
|
| 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 | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months |
body weight
| 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) | 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) | Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |