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

Primary Purpose

Diabetic Nephropathies

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
soy protein drink
casein protein drink
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    soy protein drink

    casein protein drink

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    24-hours dietary recall
    Estimated by registered dietitian to understand calories, protein and nutrients intake..
    estimated glomerular filtration rate (eGFR)
    renal function
    creatinine
    renal function
    plasma malondialdehyde (MDA)
    Antioxidative statement-lipid peroxidation
    high-sensitivity C-reactive protein (hs-CRP)
    inflammatory indicators
    soluble intercellular adhesion molecule (sICAM)-1
    inflammatory indicators
    soluble vascular cell adhesion molecule (sVICAM)-1
    inflammatory indicators
    interleukin (IL)-6
    inflammatory indicators

    Secondary Outcome Measures

    Blood pressure
    systolic blood pressure (SBP), diastolic blood pressure (DBP)
    body weight
    body weight
    blood glucose
    fasting plasma glucose (FPG)
    lipid profile
    triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)

    Full Information

    First Posted
    April 21, 2023
    Last Updated
    April 21, 2023
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05840796
    Brief Title
    To Explore the Anti-oxidative Effects and Inflammation Effects of Soy Protein to Renal Function of End Stage Diabetes Nephropathy Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    February 28, 2015 (Actual)
    Study Completion Date
    February 28, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Nephropathies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    soy protein drink
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    casein protein drink
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    soy protein drink
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    casein protein drink
    Intervention Description
    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 Outcome Measure Information:
    Title
    24-hours dietary recall
    Description
    Estimated by registered dietitian to understand calories, protein and nutrients intake..
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    estimated glomerular filtration rate (eGFR)
    Description
    renal function
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    creatinine
    Description
    renal function
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    plasma malondialdehyde (MDA)
    Description
    Antioxidative statement-lipid peroxidation
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    high-sensitivity C-reactive protein (hs-CRP)
    Description
    inflammatory indicators
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    soluble intercellular adhesion molecule (sICAM)-1
    Description
    inflammatory indicators
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    soluble vascular cell adhesion molecule (sVICAM)-1
    Description
    inflammatory indicators
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    interleukin (IL)-6
    Description
    inflammatory indicators
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Secondary Outcome Measure Information:
    Title
    Blood pressure
    Description
    systolic blood pressure (SBP), diastolic blood pressure (DBP)
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    body weight
    Description
    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
    Title
    blood glucose
    Description
    fasting plasma glucose (FPG)
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months
    Title
    lipid profile
    Description
    triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)
    Time Frame
    Change from Baseline and 4th and 7th week, the intervention will last for 4 months and follow up for 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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