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

NCT05840796 | Completed

• 1 other identifier: TTMHH-103006
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Blood pressure

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

• 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

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

• lipid profile

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

Study Arms (2)

soy protein drink

EXPERIMENTAL

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

casein protein drink

OTHER

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

Interventions

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.

soy protein drink

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.

casein protein drink

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged from 40 to 75 years and were at DN stage 4 or 5 were enrolled in this study.

Sponsors & Collaborators

• Taipei Medical University: lead

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: April 1, 2014
• Primary Completion: February 28, 2015
• Study Completion: February 28, 2015
• Last Updated: May 3, 2023

Record last verified: 2023-04