Influence of a specific diet on chronic kidney disease progressio
Not Applicable
Completed
- Conditions
- Increase the quality of life of patients with chronic kidney disease.Urological and Genital Diseases
- Registration Number
- ISRCTN10446067
- Lead Sponsor
- niversity of Milan
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35011106/ (added 20/12/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Patients:
1. CKD from stage 3a to 4 (defined according to the GFR values of the KDOQI guide-lines), not being on hemodialysis treatment
2. Age = 18 years
3. Absence of: chronic infections, active neoplasm, vasculitis, autoimmune or acute inflammatory diseases, gastro-intestinal pathologies, dementia, steroid therapies, and pregnancy
Healthy volunteers:
1. Age and sex-matched with CKD group
2. Absence of CKD or other kidney-related pathologies
Exclusion Criteria
All groups:
Presence of: chronic infections, active neoplasm, vasculitis, autoimmune or acute inflammatory diseases, gastro-intestinal pathologies, dementia, steroid therapies, and pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Nutritional, inflammatory and oxidative status measured using 3-days food diary, bioimpedance, ELISA immunological test for eight cytokines/chemokines on plasma and lipoperoxidation levels on plasma (TBARS assay) at baseline, after 3 months and after 6 months<br> 2. CKD progression measured using glomerular filtration rate (eGFR, CKD-EPI formula) at baseline, after 3 months and after 6 months<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Gut microbiota measured using Next Generation Sequencing (Ion 16S Metagenomics Kit) on DNA extracted from stool samples at baseline, after 3 months and after 6 months<br> 2. Uremic toxins measured using mass spectrometry (LC-MS/MS) at baseline, after 3 months and after 6 months<br>