Effect of Methyl-donor Nutrient Supplementation on Methylation Profile of Inflammatory-related Genes in Lupus Patients With Obesity: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change from baseline on serum vitamin B12 concentrations at 12 weeks
研究概览
简要总结
Dietary supplementation with methyl donors has been demonstrated to increase DNA methylation in leucocytes whereas a limited dietary intake of methyl donors was associated with DNA hypomethylation. Considering SLE disease, previously study showed that high doses of vitamin B6 and folate were associated with less severe SLE. Furthermore, some evidences reported a relatively high incidence of decreased serum B12 levels in rheumatic patients. This led to the suggestion that diets rich in methyl group donors could have beneficial effects on SLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Current infection
- •Arterial hypertension
- •Pregnancy
- •Anticoagulants use
- •Methotrexate use
- •Other autoimmune diseases
- •Current vitamin B12 or/and folic acid supplementation
结局指标
主要结局
Change from baseline on serum vitamin B12 concentrations at 12 weeks
时间窗: Baseline and 12 weeks
Serum vitamin B12 concentrations in pg/mL
Change from baseline on DNA methylation profile at 12 weeks
时间窗: Baseline and 12 weeks
Percentage of DNA methylation level
Change from baseline on weight at 12 weeks
时间窗: Baseline and 12 weeks
Weight in kilograms
Change from baseline on serum folic acid concentrations at 12 weeks
时间窗: Baseline and 12 weeks
Serum folic acid concentrations in ng/mL
次要结局
- Change from baseline on STAT3 gene expression at 12 weeks(Baseline and 12 weeks)
- Duration of disease since diagnosis(Baseline)
- Change from baseline on miR-146 expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on miR-181 expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on miR-126 expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on LEP gene expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum adipokines concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum triglycerides concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on height at 12 weeks(Baseline and 12 weeks)
- Age of onset(Baseline)
- Change from baseline on miR-21 expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on TNF-a gene expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on ADIPOQ gene expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on MTHFR gene expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on dietary intake at 12 weeks(Baseline and 12 weeks)
- Change from baseline on fat free mass at 12 weeks(Baseline and 12 weeks)
- Change from baseline on IL-6 gene expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on DNMT1 gene expression at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum leptin concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum IL-6 concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum IL-17 concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum IL-2 concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum C-reactive protein concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum cholesterol concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on abdominal circumference at 12 weeks(Baseline and 12 weeks)
- Change from baseline on fat mass at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum glucose concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on serum TNF-a concentrations at 12 weeks(Baseline and 12 weeks)
- Change from baseline on body mass index at 12 weeks(Baseline and 12 weeks)
研究者
Bruno Gualano
Professor
University of Sao Paulo