The Effects of Oral Nanocurcumin on Expression Levels of microRNAs and Treg Cells and Th17 Cells Development Factors in Ankylosing Spondylitis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Assessments of Ankylosing Spondylitis Signs and Symptoms (BASDI)
研究概览
简要总结
Ankylosing Spondylitis (AS) is a chronic rheumatic disease that principally affects the intervertebral and sacroiliac joints. Two major features of AS are inflammation and bone reformation. Th17 cells as a new subpopulation of CD4+ T cells, are characterized by the production of pro-inflammatory cytokines. Th17 cells have been implicated in autoimmune diseases, pathogenesis and diagnosis of several inflammatory diseases, such as AS. Regulatory T cells (Treg) with suppressive effects on inflammation and autoimmunity have been reported to implicate in pathology of AS. The Treg /Th17 functional balance is essential for the prevention of autoimmune and inflammatory diseases by preventing deleterious impairment to the host and mounting effective immune responses. A group of circulating miRNA in plasma is found to be the change they can be involved in inflammation or inhibit it. miRNAs have been shown to play a pivotal role in the pathogenesis of various diseases including autoimmune or auto-inflammatory diseases.The function and molecular pathways of several key deregulated miRNAs, are elucidated in AS patients. Curcumin is an active component of turmeric which is a perennial plant. Curcumin is able to exert anti-atherogenic, anti-cancer and anti-inflammatory effects. The curcumin induces down-regulation of various inflammatory cytokines including TNF-α and IL-1. The solubility of curcumin in nanomicelles spherical water increases to more than 100 thousand times, which significantly enhances the absorption of curcumin. The aim of the present study was to understand the nano-curcumin effects on frequency of Treg and Th17 cells, expression levels of their associated transcription factors and cytokines, secretion levels of their associated cytokines and also related miRNAs expression levels in peripheral blood of patients with AS and their correlation with the disease progression.
详细描述
A16-weeks randomized placebo-controlled study was conducted on a total of 24 patients with age range of 22 to 50, who were clinically diagnosed with ankylosing spondylitis on the basis of clinical manifestations. The AS patients were divided into 2 subgroup with a block randomization, 12 out of 24 received a daily dose of 80 mg oral nano-curcumin and 12 patients received placebo as control group in a period of 4 months. Peripheral blood samples (8 ml) were obtained from the patients in both control and treatment groups before and after nano-curcumin treatment for 4 months. PBMCs were isolated from samples using Ficoll separation technique. Subsequently, cells were cultured in the presence of PMA. Treg cells associated immunological parameters such as mRNA expression levels of mir-146a, mir-27 and mir-17, TGF-β, IL-10, IL-6 and FoxP3 and alsoTh17 related immunological parameters such as mRNA expression of mir-141, mir-155 and mir-200, IL-17, IL-23 and RORγt were measured by real-time PCR, also Treg and Th17 frequency and their related cytokines secretion levels were evaluated respectively by flowcytometry and ELISA technique in both groups, pre and post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 23 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to cooperate
- •Aged 22 to 50 years
- •The diagnosis of ankylosing spondylitis by rheumatologist
- •Patients with a BASDAI > 4 as having active disease.
- •Disease duration 5-8 years
排除标准
- •Nutritional supplements and antioxidant alpha-lipoic acid a month before the study.
- •Pregnancy and lactation
- •History of diabetes and other chronic diseases
- •History of other autoimmune diseases
- •Occurrence of relapses during the study period
- •Acceptance rate of less than 70% of supplements
- •Unwillingness to continue to cooperate
研究组 & 干预措施
Nanocurcumin Arm
Nanocurcumin capsules (the formulation of curcumin nanoparticles, Exirnanosina). Subjects randomized to Nanocurcumin Arm will receive 80 mg/day for 4 months.
干预措施: Nanocurcumin (Drug)
Placebo
Subjects randomized to Placebo Arm will receive placebo in the form of capsules for 4 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Assessments of Ankylosing Spondylitis Signs and Symptoms (BASDI)
时间窗: 4 months after treatment
Number of Subjects With a Reduction in Signs and Symptoms
次要结局
- mir-141, mir-155 and mir-200 expression(4 months after treatment)
- IL-17 expression(4 months after treatment)
- Treg cells frequency(4 months after treatment)
- RORγt expression(4 months after treatment)
- Serum IL-17 levels(4 months after treatment)
- mir-27, mir-17 and mir-146a expression(4 months after treatment)
- FoxP3 expression(4 months after treatment)
- Th17 cells frequency(4 months after treatment)
- Serum TGF-β, IL-10, IL-6 levels(4 months after treatment)
- TGF-β, IL-10, IL-6 expression(4 months after treatment)
研究者
Mehdi Yousefi
Director
Tabriz University of Medical Sciences