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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brazil nut | Experimental | Each patient will receive 30 units of Brazil nuts per month, to consume one nut/day for two months. The time and daily amount of nuts were based on the European Food Safety recommendation Authority (EFSA). The adequate value for selenium intake was determined by EFSA aiming at the maximum serum concentration of Selenoprotein P and glutathione peroxidase activity, reached between four and 10 weeks, with 70 µg/day; we consider that a Brazil nut can contain up to 400 µg of Se. The use of fresh nuts made it impossible to use a placebo with the same sensory characteristics. Then, in the control stage, volunteers will receive conventional conservative nutritional treatment, without nut supplementation. |
|
| Washout | No Intervention | Time T2 will be a washout period , so that residual effects between stages T1 and T3 are avoided. | |
| Crossover | No Intervention | the crossover between the groups will allow the same participant to be exposed, at different times, to the intervention stage and the control stage. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brazil Nut | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in antioxidants and anti-inflammatory biomarkers | Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory biomarkers | 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). | 8 weeks |
| Change in microbiota composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renata Rodrigues, MS | Universidade Federal do Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise Mafra | Rio de Janeiro | Rio de Janeiro | 22260050 | Brazil |
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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.
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DNA extraction from fecal samples will be carried out using the kit QIAamp DNA Stool Mini Kit. |
| 8 weeks |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C103364 | 2S albumin, brazil nut |
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