Influence of a specific diet on chronic kidney disease progression

ISRCTN ISRCTN10446067
DOI https://doi.org/10.1186/ISRCTN10446067
Secondary identifying numbers MRC2017/ST/035
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Francesca Pivari
Scientific

University of Milan
via A. di Rudinì, 8
Milan
20142
Italy

ORCiD logoORCID ID 0000-0002-2277-6833
Phone +39 3289580644
Email francesca.pivari@unimi.it

Study information

Study designInterventional non-randomized
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleInfluence of a specific diet on the intestinal microbiota, malnutrition, inflammation and oxidation in chronic kidney disease
Study acronymNutriCKD
Study objectivesThe 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) studiedIncrease the quality of life of patients with chronic kidney disease.
InterventionTo 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 typeSupplement
Primary outcome measure1. 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
2. CKD progression measured using glomerular filtration rate (eGFR, CKD-EPI formula) at baseline, after 3 months and after 6 months
Secondary outcome measures1. 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
2. Uremic toxins measured using mass spectrometry (LC-MS/MS) at baseline, after 3 months and after 6 months
Overall study start date01/01/2017
Completion date01/10/2021

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants30
Total final enrolment24
Key inclusion criteriaPatients:
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 criteriaAll groups:
Presence of: chronic infections, active neoplasm, vasculitis, autoimmune or acute inflammatory diseases, gastro-intestinal pathologies, dementia, steroid therapies, and pregnancy.
Date of first enrolment01/10/2018
Date of final enrolment01/10/2019

Locations

Countries of recruitment

  • Italy

Study participating centre

San Paolo Hospital - Milan
Via A. di Rudinì, 8
Milan
20142
Italy

Sponsor information

University of Milan
University/education

Via A. di Rudinì, 8
Milan
20142
Italy

Phone +39 02 5032 5032
Email segreteria.diss@unimi.it
Website http://www.unimi.it/ENG/
ROR logo "ROR" https://ror.org/00wjc7c48

Funders

Funder type

University/education

Università degli Studi di Milano
Private sector organisation / Universities (academic only)
Alternative name(s)
Universitas Studiorum Mediolanensis, University of Milan, La Statale, UniMi
Location
Italy

Results and Publications

Intention to publish date01/01/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in high-impact peer-reviewed journal.
IPD sharing planAvailable 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

Editorial Notes

20/12/2022: Publication reference added.
04/01/2022: Trial's existence confirmed by Ethics Committee Milano Area 1.