Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Inflammation, Inflammatory Response, Oxidative Stress, Intestinal Microbiota
Conditions
Keywords
Chronic Kidney Diseases, Conservative treatment, Inflammation, Oxidative stress, Intestinal microbiota, Brazil Nut
Brief summary
The aim of this study is to evaluate the effects of Brazil nut supplementation on inflammation, oxidative stress and intestinal microbiota in patients with chronic kidney disease undergoing conservative treatment.
Detailed description
Complications such as inflammation and oxidative stress are common in chronic kidney disease (CKD) and directly influence the rate of disease progression. Patients with CKD also have intestinal dysbiosis, which aggravates the inflammatory process and oxidative stress, forming a vicious circle between inflammation, oxidative stress and intestinal dysbiosis. Nutritional strategies try to alleviate this circle and Brazil nuts, rich in bioactive compounds, have already been proven effective in mitigating inflammation and oxidative stress in CKD patients on dialysis. However, to date, the effectiveness of Brazil nuts in patients with CKD in stages prior to dialysis (conservative treatment) has not been tested. The bioactive compounds in Brazil nuts are expected to contribute positively to the redox balance, reduction of inflammation and intestinal eubiosis in patients with CKD undergoing conservative treatment.
Interventions
DIETARY_SUPPLEMENTBrazil Nut
The intervention, for each participant, is estimated to last a total period of six months , which will be divided into three two-month stages, with data collection after each stage. Volunteers will be monitored to control possible side effects, doubts and check compliance. In addition, the telephone number and an email will be made available for contact during business hours, for possible clarifications.
Sponsors
Universidade Federal Fluminense
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
A longitudinal, prospective clinical trial will be carried out with patients with CKD undergoing conservative treatment. Volunteers will be randomized into groups G1 and G2, and in the first stage, G1 will be in the intervention group and G2 in the control group. In the second stage, everyone will undergo washout and, in the third stage, a crossover between groups will be carried out, passing G2 to intervention and G1 to control.
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Patients with more than three months of nutritional monitoring at the Renal Nutrition Outpatient Clinic of the Universidade Federal Fluminense (UFF), between stages G3a and G4, will be included, according to KDOQI 2020 guidelines, and authorized by the medical and nutritionist team.
Exclusion criteria
* Current use or in the last three months of antibiotics, anti-inflammatories and/or antioxidant supplements. Patients who are allergic, intolerant, or regularly ingest Brazil nuts; pregnant/lactating women, smokers; undergoing cancer treatment, HIV-positive, or with any clinical condition that compromises the accuracy of the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in antioxidants and anti-inflammatory biomarkers | 8 weeks | Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammatory biomarkers | 8 weeks | Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha). |
| Change in microbiota composition | 8 weeks | DNA extraction from fecal samples will be carried out using the kit QIAamp DNA Stool Mini Kit. |
Countries
Brazil
Contacts
Primary ContactDenise Mafra, Ph.D
Backup ContactRenata Rodrigues, MS
Outcome results
None listed