The Effects of Nanomicielle Curcumin on Oxidative Stress, Systemic Inflammation, Adiponectin in Serum and NF-kB in Blood Mononuclear Cells, in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum C-reactive protein (CRP)
研究概览
简要总结
Metabolic syndrome is a public health challenge that includes a range of conditions including abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. The syndrome is associated with an increase in the risk of Cardiovascular disease and death. Curcumin is a very active compound obtained from turmeric root. Curcumin has antioxidant and anti-inflammatory effects, and is also involved in the regulation of several signaling pathways. Since curcumin powder has low bioavailability, fast metabolism and low absorption, nanomicielle curcumin will be used in this study. Therefore, this study is planned to determine the effects of supplementation of nanomicielle curcumin on oxidative stress, systemic inflammation, adiponectin in serum and NF-kB in peripheral blood mononuclear cells in patients with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* waist circumference \>102 cm in men or \>88 cm in women
- •* Fasting blood glucose \>100 mg/dL
- •* Triglycerides (TG) \> 150 mg/dL
- •* High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men
- •* Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg
排除标准
- •insulin administration for diabetes control
- •hypo- or hyperthyroidism,
- •renal failure or other chronic diseases
- •pregnancy and breastfeeding
- •taking weight loss supplements and obeying unusual weight loss plans
研究组 & 干预措施
intervention group
80 mg nanomicielle curcumin capsules once a day for 12 weeks
干预措施: nanomicielle curcumin (Dietary Supplement)
control group
placebo capsules once a day for 12 weeks
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Serum C-reactive protein (CRP)
时间窗: 12weeks
Serum Adiponectin
时间窗: 12weeks
Serum Total antioxidant capacity (TAC)
时间窗: 12 weeks
Serum Malondialdehyde (MDA)
时间窗: 12weeks
Serum curcumin
时间窗: 12 weeks
NF-kB(p65) transcription in PBMC
时间窗: 12weeks
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
clinical professor
National Nutrition and Food Technology Institute
