To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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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
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Diabetic Nephropathies

Intervention / Treatment
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* Dietary Supplement: soy protein drink
* Dietary Supplement: casein protein drink


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soy protein drink<br>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. | Dietary Supplement: soy protein drink<br>* 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.<br>|
| Other: casein protein drink<br>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. | Dietary Supplement: casein protein drink<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |