Effects of Supplementation With Microcapsules of Tumeric and Propolis on Inflammatory Markers in Patients on Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- The effects of the supplementation on inflammatory cytokines
研究概览
简要总结
Oxidative stress and inflammation are correlated with Chronic Kidney Disease (CKD), in a way that they bring several harms to patients, including an increased risk of cardiovascular disease and mortality. Adjuvant therapeutic options such as bioactive compounds present in some foods seem to mitigate inflammation. Turmeric and propolis are foods that have compounds with antioxidant and anti-inflammatory capacity, as they promote the activation of nuclear erythroid transcription factor 2 (Nrf2 - responsible for the synthesis of antioxidant enzymes) and inhibit the activity of nuclear factor Kappa B (NF-κB - which increases the synthesis of inflammatory cytokines). This work aims to evaluate the effects of supplementation of associated propolis and turmeric microcapsules on inflammatory markers in patients with CKD undergoing hemodialysis (HD).
详细描述
The so-called Chronic Non-Communicable Diseases (NCDs) have been increasing in incidence. Among these, one can mention Chronic Kidney Disease (CKD). CKD is considered a public health problem and is characterized by an irreversible syndrome resulting from changes in the function or structure of the kidney, which has a progressive evolution.
Oxidative stress is one of the most potent inducers of inflammation, being an imbalance between the production of reactive oxygen species (ROS) and cellular antioxidant capacity, so that such imbalance can influence the activation of the nuclear factor kB (NF-κB), inflammation-associated interleukins, and tumor necrosis factor alpha 4 (TNF-α), which are promoters of cell damage and organic molecules. Patients with CKD on HD showed increased expression of NF-κB and reduced expression of Nrf2, so it is important to perform studies that propose ways to increase the performance of Nrf2, as well as reduce the activation of NF-κB. the performance of propolis and turmeric.
The study aims to evaluate the effects of supplementation of propolis and turmeric microcapsules on inflammatory markers and clinical parameters in patients with chronic kidney disease undergoing hemodialysis.
Sample calculation was performed using the G-Power 3.1 software, with a test power of 80%, considering the expression of NF-κB as the main outcome, significance level of 5% (two-tailed), effect size of 1, 32. The sample obtained consisted of 34 patients (17 in each group).
The proposed clinical study is a longitudinal randomized and double-blind (randomized controlled trial - RCT) where patients will receive capsules containing microencapsulated turmeric and propolis, twice a day, for 12 weeks. The mixture of microcapsules of propolis and turmeric will be distributed to participants in the form of hard gelatine capsules. The placebo group will receive the same amount of capsules, at the same times, containing gum arabic and corn starch. Randomization will be computerized in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage 5 CKD (GFR < 15 mL/min);
- •On hemodialysis for more than 6 months;
- •Who have arteriovenous fistula (AVF) as vascular access
排除标准
- •Pregnant women;
- •Using antibiotics in the last 3 months;
- •Using antioxidant supplements;
- •Who have habitual intake of propolis, curcumin and turmeric;
- •With autoimmune and infectious diseases, cancer, liver and AIDS (Acquired Immunodeficiency Syndrome)
结局指标
主要结局
The effects of the supplementation on inflammatory cytokines
时间窗: 4 months
Get blood samples to evaluate the supplementation effects on cytokines (IL-6, TNF-α)
The effects of the supplementation on the expression of transcription factors
时间窗: 4 months
Obtain blood samples to assess the effects of supplementation on biomarkers related to inflammation and antioxidant capacity, such as: erythroid nuclear transcription factor 2 (Nrf2) and nuclear factor Kappa B (NF-κB)
次要结局
- The effects of supplementation on CRP levels(4 months)