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

Diabetic Nephropathies Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840796
• Other study ID #: TTMHH-103006
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: February 28, 2015

Study information

• Verified date: April 2023
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 28, 2015
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	creatinine	renal function	Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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