Influence of a specific diet on chronic kidney disease progression
| ISRCTN | ISRCTN10446067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10446067 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | MRC2017/ST/035 |
| Sponsor | University of Milan |
| Funder | Università degli Studi di Milano |
- Submission date
- 22/12/2021
- Registration date
- 04/01/2022
- Last edited
- 20/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys don't work as well as they should.
The aim of our study is to understand the interaction between the nutritional, inflammatory, and oxidative status and the gut microbiota composition in CKD patients. The project also aims at generating new knowledge on the role played by diet in CKD and at translating emerging evidence in secondary prevention interventions to limit the worsening of CKD status and to improve patients’ nutritional status.
Who can participate?
Thirty patients with CKD (stage 3b-5, not on haemodialysis treatment) and twenty healthy subjects will be recruited at the San Paolo Hospital, Unit of Nephrology and Dialysis.
What does the study involve?
CKD patients receive curcumin (Meriva® 500 mg/tablet twice in a day) for 3 or 6 months. Meriva® was supplied by INDENA S.p.A. (Milan, Italy) as a food-grade lecithin formulation of curcumin in 500mg film-coated tablets, containing a standardized amount of 100 mg highly bioavailable curcuminoids. At baseline (T0), after 3 months (T1) and 6 months (T2) of Meriva® supplementation, we collect: patients’ clinical parameters, anthropometric and body composition measures, dietary habits, stool and blood samples.
What are the possible benefits and risks of participating?
Meriva® is a safe curcumin supplement currently on the market. The recruited patients will be followed from a nutritional point of view, which can bring health benefits. The study involves no health risks.
Where is the study run from?
San Paolo Hospital - Milan. University of Milan (Italy).
When is the study starting and how long is it expected to run for?
January 2017 to October 2021
Who is funding the study?
University of Milan (Italy).
Who is the main contact?
Dr Francesca Pivari, francesca.pivari@unimi.it
Contact information
Scientific
University of Milan
via A. di Rudinì, 8
Milan
20142
Italy
 ORCID ID |
0000-0002-2277-6833 |
|---|---|
| Phone | +39 3289580644 |
| francesca.pivari@unimi.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomized |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Influence of a specific diet on the intestinal microbiota, malnutrition, inflammation and oxidation in chronic kidney disease |
| Study acronym | NutriCKD |
| Study objectives | The purpose of the study is to investigate the anti-inflammatory and antioxidant action of specific foods and to understand their interaction with the composition of the intestinal microbiota in patients with chronic kidney disease. |
| Ethics approval(s) | Approved 08/01/2017, Ethics Committee Milano Area 1 (ASST Fatebenefratelli Sacco, Via G.B Grassi, 74. 20157 - Milano, Italy; no telephone number provided; comitato.etico@asst-fbf-sacco.it), ref. Protocollo MRC 2017/ST/035. |
| Health condition(s) or problem(s) studied | Increase the quality of life of patients with chronic kidney disease. |
| Intervention | To ameliorate the quality of life in chronic kidney disease (CKD) subjects, the use of dietary supplements has increased over time. Among those, curcumin has demonstrated significant in vitro anti-inflammatory properties. In this pilot study, 24 CKD patients and 20 healthy volunteers were recruited. CKD patients followed nutritional counselling and were supplemented with curcumin (1g/day Meriva®) for six months. Different parameters were evaluated at baseline and after 3-6 months: uremic toxins, metagenomic of gut microbiota, nutritional, inflammatory and oxidative status. Healthy volunteers: completed a 3-days food diary to record their eating habits; bioimpedance analysis; collected stool samples to analyze gut microbiota composition. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/10/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 24 |
| Key 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 |
| Key exclusion criteria | All groups: Presence of: chronic infections, active neoplasm, vasculitis, autoimmune or acute inflammatory diseases, gastro-intestinal pathologies, dementia, steroid therapies, and pregnancy. |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 01/10/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milan
20142
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Available on request. (francesca.pivari@unimi.it) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 05/01/2022 | 20/12/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/12/2022: Publication reference added.
04/01/2022: Trial's existence confirmed by Ethics Committee Milano Area 1.
