Clinical trial NCT05840796: To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathies
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24-hours dietary recall
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: estimated glomerular filtration rate (eGFR)
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: creatinine
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: plasma malondialdehyde (MDA)
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: high-sensitivity C-reactive protein (hs-CRP)
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: soluble intercellular adhesion molecule (sICAM)-1
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: soluble vascular cell adhesion molecule (sVICAM)-1
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: interleukin (IL)-6
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Secondary outcomes:
measure: Blood pressure
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: body weight
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: blood glucose
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
measure: lipid profile
timeFrame: Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
Other outcomes:
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