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临床试验/NCT03534024
NCT03534024Unknown不适用

The Effects of Nanomicelles Curcumin on Glycemic Control, Serum Lipid Profile ,Blood Pressure and Anthropometric Measurements 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 total Cholesterol

研究概览

简要总结

Metabolic syndrome is a condition which is recognized by abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. Curcumin has beneficial effects such as antioxidant and anti-inflammatory effects. nanomcielle curcumin will be used in this study because of the low bioavailability , fast metabolism and low absorption of curcumin powder. Therefore, this study is planned to determine the effects of supplementation of nanomicelle curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements 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

nanomicielle curcumin

Active Comparator

干预措施: nanomicielle curcumin (Dietary Supplement)

plecebo

Placebo Comparator

干预措施: placebo (Dietary Supplement)

结局指标

主要结局

serum total Cholesterol

时间窗: 12 weeks

hemoglobin A1c (HbA1c)

时间窗: 12 weeks

serum glucose

时间窗: 12weeks

serum insulin

时间窗: 12weeks

homeostatic model assessment of insulin resistance(HOMA-IR)

时间窗: 12weeks

homeostatic model assessment of beta cell(HOMA-B)

时间窗: 12weeks

serum triglyceride (TG)

时间窗: 12 weeks

serum LDL-C

时间窗: 12 weeks

serum HDL-C

时间窗: 12 weeks

systolic blood pressure

时间窗: 12 weeks

diastolic blood pressure

时间窗: 12 weeks

serum curcumin

时间窗: 12 weeks

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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