Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- Universidade Federal Fluminense
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Change in antioxidants and anti-inflammatory biomarkers
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The objective of this study is to evaluate the supplementation with tocotrienol, a vitamin E compound on inflammation, oxidative stress, and microbiota on Chronic Kidney Disease patients.
Detailed Description
In Chronic Kidney Disease (CKD), inflammation and oxidative stress are common statuses, which are aggravated by renal replacement therapy such as hemodialysis. Currently, intestinal microbiota imbalance has been associated with both inflammation and oxidative stress. In this regard, strategies in the management of this framework are necessary. It has been observed that vitamin E plays an important role in the modulation of transcription factors involved in inflammation such as NF-kB and Nrf2, acting on cell membrane protection and tissue recovery. Its benefits have been proven both in renal and intestinal health, however, studies analyzing the vitamin E supplementation in the modulation of intestinal microbiota with consequent effect on CKD and its reflexes are scarce. Thus, the current randomized, double-blind, placebo-controlled study will evaluate the effects of vitamin E supplementation on the modulation of the expression of nuclear cytokine (NF-kB e Nrf2), activators and inhibitors, as well as, on inflammation and oxidative stress and on the modulation of the intestinal microbiota in patients CKD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chronic kidney disease
- •Aged from 18 to 60 years
- •Must be able to swallow capsules
Exclusion Criteria
- •Pregnant patients
- •Using antibiotics in the last 3 months
- •Using antioxidant supplements in the last 3 months
- •Usual intake Autoimmune
- •Hemodialysis started less than 6 months for hemodialysis patients
Outcomes
Primary Outcomes
Change in antioxidants and anti-inflammatory biomarkers
Time Frame: 4 weeks
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1). glutathione peroxidase (GPx), heme oxygenase-1 (HO-1) and microbiota composition from patients feces DNA uremic toxins
Secondary Outcomes
- Change in inflammatory biomarkers(4 weeks)