KPs Supplement for Inflammation, Oxidative Stress and Lipid Abnormalities in CKD Patients.
NCT ID: NCT07260292
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
165 participants
INTERVENTIONAL
2023-08-01
2024-08-01
Brief Summary
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Detailed Description
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Probiotics and postbiotics have been evaluated as potential adjunct therapies to slow CKD progression; however, conclusive evidence supporting their clinical effectiveness remains limited. Kefir peptides (KPs) contain bioactive constituents with documented antioxidant, antidiabetic, antithrombotic, antibacterial, anti-osteoporotic, and immunomodulatory properties. Based on these characteristics, KPs may offer therapeutic benefits in modulating renal function, systemic inflammation, and uremic toxin burden in individuals with advanced CKD.
The current investigation aims to examine the effects of kefir peptides on renal function and clinical proteinuria, and to explore possible mechanistic pathways contributing to these outcomes.
Methods A total of 165 participants were enrolled: 83 in the placebo group and 82 in the kefir peptide group. All participants consumed the assigned kefir formulation twice daily for three months. Blood and urine biochemical assessments were conducted at baseline (week 0), week 4, and week 12. Serum high-sensitivity C-reactive protein (hs-CRP), indoxyl sulfate (IS), and p-cresyl sulfate (PCS) levels were measured at baseline and at week 12. All study procedures and monitoring activities were performed by the investigator.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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KEFPEP®
Powder (directly take the powder with appropriate amount of warm water)
KEFPEP®
oral administration at a daily dosage of 2.4 grams for 12 weeks
Placebo
Powder (directly take the powder with appropriate amount of warm water)
Placebo
using regular yogurt powder as a substitute for KPs
Interventions
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KEFPEP®
oral administration at a daily dosage of 2.4 grams for 12 weeks
Placebo
using regular yogurt powder as a substitute for KPs
Eligibility Criteria
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Inclusion Criteria
* Chronic kidney disease stage 3 and 4
* Sign informed consent
Exclusion Criteria
* Pregnancy
* Aboriginal descent
30 Years
82 Years
ALL
No
Sponsors
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Jen Ai Hospital
UNKNOWN
National Chung Hsing University
OTHER
Responsible Party
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Chuan -Mu Chen
Chair Professor
Principal Investigators
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YU-HSIEN LIU, Master
Role: STUDY_DIRECTOR
Jen Ai Hospital
Locations
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Jen-Ai Hospital
Taichung, , Taiwan
Countries
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References
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Liu YH, Chen YH, Ko CH, Kuo CW, Yen CC, Chen W, Chong KY, Chen CM. SOD3 and IL-18 Predict the First Kidney Disease-Related Hospitalization or Death during the One-Year Follow-Up Period in Patients with End-Stage Renal Disease. Antioxidants (Basel). 2022 Jun 18;11(6):1198. doi: 10.3390/antiox11061198.
Other Identifiers
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111-89
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PHP2201H04
Identifier Type: -
Identifier Source: org_study_id