Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Effects of supplementation with tocotrienol on chronic kidney disease patients 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
Supplementation with a Vitamin E compound.
|
| Placebo Comparator: Effects of supplementation with tocotrienol on lipid profile of chronic kidney disease patients Administration of placebo containing 0,96mg of tocotrienol and 1,76mg of tocopherol twice a day for three months. |
Dietary Supplement: Tocotrienol rich fraction
Supplementation with a Vitamin E compound.
|
Outcome Measures
Primary Outcome Measures
- Antioxidants and anti-inflammatory biomarkers [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 Outcome Measures
- Inflammatory biomarkers [4 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chronic kidney disease
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Aged from 18 to 60 years
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Must be able to swallow capsules
Exclusion Criteria:
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Pregnant patients
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Smokers
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Using antibiotics in the last 3 months
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Using antioxidant supplements in the last 3 months
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Usual intake Autoimmune
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Hemodialysis started less than 6 months for hemodialysis patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Denise Mafra | Rio de Janeiro | RJ | Brazil | 22260050 |
Sponsors and Collaborators
- Universidade Federal Fluminense
- Wayne State University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Denise Mafra