Effects of Oral Ginger Supplementation on NF-KB (Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells) in Peripheral Blood Mononuclear Cells (PBMC) and Glycemic and Lipid Profiles in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Change from Baseline in NF-KB at 10 weeks
研究概览
简要总结
This study evaluates the effect of ginger on NF-KB level in Peripheral Blood Mononuclear Cells in type 2 diabetic patients. Half of patients will receive ginger, while the other half will receive placebo.
详细描述
ginger is a plant with lots of phytochemicals which have antioxidant effects. It reduces the NF-KB levels in the cells because of its antioxidant effects. It can reduces insulin resistance as a result of NF-KB reduction in diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 of diabetes diagnosed for 1 to 10 years
- •age 30-60 years
- •BMI = 18.5-35 kg/m*m
- •treatment with Metformin or Glibenclamide
排除标准
- •Treatment with insulin
- •Weight loss more than 10% in 6 months
- •Treatment with TZDs (thiazolidinediones)
- •Pregnancy and breast feeding
- •Smoking and alcohol consumption
- •Multivitamin-mineral and polyphenols and omega-3 and 6 supplementation in the last 3 months and during study
- •Ginger supplementation and herbal medicines
- •Anticoagulation consumption such as heparin and warfarin
- •NSAIDs such as diclofenac and salicylate drugs such as aspirin, corticosteroids such as prednisone consumption during 1 month ago and during the study
- •Infectious and inflammatory diseases such as rheumatoid arthritis
- •Impaired hepatic, renal and gastrointestinal function
- •Currently suffering from acute illness that needs medical treatment
研究组 & 干预措施
Placebo
Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks Placebo twice daily
干预措施: placebo (Dietary Supplement)
Ginger
Ginger (Zingiber officinale Roscoe) 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
干预措施: Ginger (Dietary Supplement)
结局指标
主要结局
Change from Baseline in NF-KB at 10 weeks
时间窗: Baseline and 10 weeks
次要结局
- Change from Baseline in LDL-C (mg/dl) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in HDL-C (mg/dl) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in TG (mg/dl) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in insulin (µlU/ml) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in Hb A1C at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in FBS (mg/dl) at 10 weeks(Baseline and 10 weeks)
- Change from Baseline in Total-C (mg/dl) at 10 weeks(Baseline and 10 weeks)
研究者
Niaz Mohammadzadeh Honarvar
Assistant Professor
Tehran University of Medical Sciences