Trials / Completed
CompletedNCT04413266
Effects of Curcumin Supplementation in Patients With Chronic Kidney Disease on Peritoneal Dialysis
Effects of Curcumin Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease on Peritoneal Dialysis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Universidade Federal Fluminense · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess whether supplementation with curcumin could modulate the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress, uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal dialysis.
Detailed description
Curcumin is a chemical compound of the curcuminoids class found in the root of Curcuma (Curcuma longa), and due to its potential antioxidant and anti-inflammatory, has been suggested as a nutritional strategy to reduce oxidative stress and inflammation present in several chronic diseases. Although it is a promising therapy, there are no studies evaluating the effects of curcumin in patients with chronic kidney disease (CKD) in peritoneal dialysis (PD). The aim of this study is to evaluate the effect of curcumin supplementation on inflammatory markers and oxidative stress in patients with CKD in PD. Methods: This is a longitudinal randomized clinical double-blind crossover study, with a washout period and placebo-controlled, where patients will be randomized into two groups: Turmeric and Placebo. After the 12-week supplementation period, a washout (12 weeks) will be performed for subsequent crossover of the patients. Mononuclear cells will be extracted from whole blood and the expression of m ribonucleic acid from transcription factors (Nrf2 and NF-kB), antioxidant enzymes (NQO1, HO-1), as well as NLRP3 inflammasome will be analyzed by real-time Polymerase Chain Reaction and protein expression by western blotting. Inflammatory cytokine levels will be assessed by ELISA, also, plasma levels of TBARS, routine laboratory parameters, as well as food intake and nutritional status.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Curcumin supplementation | The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks |
Timeline
- Start date
- 2020-10-10
- Primary completion
- 2023-10-05
- Completion
- 2023-10-05
- First posted
- 2020-06-02
- Last updated
- 2023-12-14
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04413266. Inclusion in this directory is not an endorsement.