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

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).

Study Overview

• Status: Completed
• Conditions: Diabetic Nephropathies
• Intervention / Treatment: Dietary supplement: soy protein drink; Dietary supplement: casein protein drink

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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 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.
Other: 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.	Dietary supplement: 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 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): February 28, 2015
• Study Completion (Actual): February 28, 2015

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: TTMHH-103006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No