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临床试验/NCT05983224
NCT05983224Unknown不适用

Effect of Quercetin Supplementation on Glycemic Status, Lipid Profile, Oxidative Stress, Inflammation, Growth Factor, Adiponectin, Sex Hormones and Anthropometric Indices in Women With Endometriosis

National Nutrition and Food Technology Institute2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Mean serum TNF-alpha concentration

研究概览

简要总结

Quercetin is a polyphenol compound that possesses anti-inflammatory properties and can be found in various food sources like apples, berries, cabbage, and onions. In Park et al.'s study, it was discovered that quercetin led to a significant decrease in the proliferation of endometriosis cells. Furthermore, quercetin also triggered apoptosis in endometriosis cells in vitro and reduced the size of endometriosis lesions in vivo. Nevertheless, as of now, there have been no studies conducted in Iran or worldwide that explore the effects of quercetin supplementation on individuals with endometriosis. Hence, the aim of this study is to investigate the impact of quercetin supplementation on factors such as glycemic status, lipid profile, oxidative stress, inflammation, growth factors, adiponectin, sex hormones, and anthropometric indicators in women suffering from endometriosis.

详细描述

The participants in the study were randomly assigned to two groups: the intervention group and the control group. The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks. On the other hand, the control group will be given a placebo. Blood samples will be collected before and after the intervention to measure changes in blood lipid profile, fasting blood sugar, sex hormones (testosterone, estrogen, progesterone), TNFα, IL-6, adiponectin, IGF1, HbA1C, SHBG, FSH, LH, and plasma total antioxidant capacity.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Willing to cooperate and complete the informed consent form.
  • Diagnosed endometriosis using laparoscopy and histopathological tests.
  • In the age group of 18 to 40 years.
  • Having a regular menstrual cycle.
  • Having a body mass index between 18.5 and 30.

排除标准

  • Using hormonal medications or intrauterine treatments for a minimum of three months prior to collecting a sample.
  • Having immune system disorders, persistent infections, diabetes, or any conditions like polyps and fibroids within the uterine cavity.

结局指标

主要结局

Mean serum TNF-alpha concentration

时间窗: 12 weeks

Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit

Mean serum IL-6 concentration

时间窗: 12 weeks

Human Interleukin 6, IL-6 ELISA Kit

次要结局

  • Mean Serum Testosterone concentration(12 weeks)
  • Mean Serum Estrogen concentration(12 weeks)
  • Mean Serum FSH concentration(12 weeks)
  • Mean HbA1C Serum(12 weeks)
  • Mean Serum Adiponectin concentration(12 weeks)
  • Mean Serum Progesterone concentration(12 weeks)
  • Mean Serum FBS concentration(12 weeks)
  • Mean Serum SHBG concentration(12 weeks)
  • Mean plasma total antioxidant capacity concentration(12 weeks)
  • Mean Serum IGF1 concentration(12 weeks)
  • Mean Serum LH concentration(12 weeks)

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

Ghazaleh Eslamian

Principal Investigator

National Nutrition and Food Technology Institute

研究点 (2)

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