Skip to main content
OpenTrials
Completed

NCT Number: NCT05840796

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Nephropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

soy protein drink

Dietary 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 drink

Dietary 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.

Primary outcomes

  1. 24-hours dietary recall

    Time frame: 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..

  2. estimated glomerular filtration rate (eGFR)

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

    renal function

  3. creatinine

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

    renal function

  4. plasma malondialdehyde (MDA)

    Time frame: 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

  5. high-sensitivity C-reactive protein (hs-CRP)

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

    inflammatory indicators

  6. soluble intercellular adhesion molecule (sICAM)-1

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

    inflammatory indicators

  7. soluble vascular cell adhesion molecule (sVICAM)-1

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

    inflammatory indicators

  8. interleukin (IL)-6

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

    inflammatory indicators

Secondary outcomes

  1. Blood pressure

    Time frame: 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)

  2. 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

    body weight

  3. blood glucose

    Time frame: 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)

  4. lipid profile

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.