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临床试验/NCT03514667
NCT03514667Unknown不适用

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

National Nutrition and Food Technology Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年8月30日最近更新:
适应症
干预措施

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

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

Active Comparator

80 mg nanomicielle curcumin capsules once a day for 12 weeks

干预措施: nanomicielle curcumin (Dietary Supplement)

control group

Placebo Comparator

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

发起方
National Nutrition and Food Technology Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Azita Hekmatdoost

clinical professor

National Nutrition and Food Technology Institute

研究点 (1)

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