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KPs Supplement for Inflammation, Oxidative Stress and Lipid Abnormalities in CKD Patients.

Kefir Peptides Supplement for Inflammation, Oxidative Stress and Lipid Abnormalities in Chronic Kidney Disease Patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07260292
Acronym
KPs; CKD
Enrollment
165
Registered
2025-12-03
Start date
2023-02-03
Completion date
2024-08-02
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Proteinuria

Keywords

Chronic kidney disease, Gut dysbiosis, Proteinuria, Kefir peptides,, Postbiotics

Brief summary

This clinical investigation is designed to evaluate the potential therapeutic effects of kefir peptides as an adjunct intervention for chronic kidney disease (CKD) and clinical proteinuria. Patients diagnosed with stage 3 or 4 CKD will receive a three-month course of kefir peptide supplementation. Throughout the intervention period, the investigator will monitor renal function markers (blood urea nitrogen, serum creatinine), proteinuria (urine protein-to-creatinine ratio), inflammatory indicators (high-sensitivity C-reactive protein), and additional biochemical parameters relevant to CKD progression.

Detailed description

Background and Aim Chronic kidney disease (CKD) represents a substantial global public health burden, with prevalence rising due to population aging and an increased incidence of systemic conditions such as hypertension, diabetes mellitus, metabolic syndrome, and chronic exposure to nephrotoxic agents. Accumulation of uremic toxins in CKD contributes to gut dysbiosis, systemic inflammation, accelerated renal functional decline, and heightened cardiovascular risk. 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.

Interventions

DIETARY_SUPPLEMENTKEFPEP®

oral administration at a daily dosage of 2.4 grams for 12 weeks

DIETARY_SUPPLEMENTPlacebo

using regular yogurt powder as a substitute for KPs

Sponsors

National Chung Hsing University
Lead SponsorOTHER
Jen Ai Hospital
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants and investigators were unaware of group assignment; placebo was identical in appearance to study

Intervention model description

This is a randomized, double-blind, placebo-controlled, parallel study

Eligibility

Sex/Gender
ALL
Age
30 Years to 82 Years
Healthy volunteers
No

Inclusion criteria

* Age: 30-82 years of age * Chronic kidney disease stage 3 and 4 * Sign informed consent

Exclusion criteria

* Acute illness * Pregnancy * Aboriginal descent

Design outcomes

Primary

MeasureTime frame
Change in renal function biomarker( BUN & Cr)Baseline to 12 weeks
Change in urine protein-to-creatinine ratio (UPCR)Baseline to 12 weeks

Countries

Taiwan

Contacts

STUDY_DIRECTORYU-HSIEN LIU, Master

Jen Ai Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026