Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients

Conditions
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Chronic Kidney Diseases, Hemodialysis, Microbiota, Oxidative Stress, Inflammation

Intervention / Treatment
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* Dietary Supplement: Tocotrienol rich fraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic kidney disease Aged from 18 to 60 years Must be able to swallow capsules Exclusion Criteria: Pregnant patients Smokers 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effects of supplementation with tocotrienol on chronic kidney disease patients<br>Administration of tocotrienol-rich-fraction (TRF) capsules, containing 360mg of tocotrienol and 80mg of tocopherol twice a day for six months. | Dietary Supplement: Tocotrienol rich fraction<br>* Supplementation with a Vitamin E compound.<br>|
| Placebo Comparator: Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients<br>Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months. | Dietary Supplement: Tocotrienol rich fraction<br>* Supplementation with a Vitamin E compound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). glutathione peroxidase (GPx), heme oxygenase-1 (HO-1) and microbiota composition from patients feces DNA uremic toxins | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4 weeks |