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

Not Applicable

Completed

• Conditions: Diabetic Nephropathies
• Interventions: Dietary Supplement: casein protein drink; Dietary Supplement: soy protein drink

• Registration Number: NCT05840796
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2015-02-28
• Study Completion: 2015-02-28
• Status Verified: 2023-04
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
casein protein drink	casein 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.
soy protein drink	soy 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.

Primary Outcome Measures

Name	Time	Method
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
creatinine	Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months	renal function
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 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
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
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..
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
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

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)