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

Taipei Medical University45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetic Nephropathies

Interventions

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

24-hours dietary recall

Estimated by registered dietitian to understand calories, protein and nutrients intake..

Time frame: 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

Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months

creatinine

renal function

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months

interleukin (IL)-6

Data from ClinicalTrials.gov

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Secondary Outcomes

Blood pressure

systolic blood pressure (SBP), diastolic blood pressure (DBP)

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

fasting plasma glucose (FPG)

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

triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)

Time frame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months