Effect of Quercetin Supplementation on Endometriosis Outcomes

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Dietary Supplement: Quercetin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quercetin<br>The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks. | Dietary Supplement: Quercetin<br>* The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.<br>|
| Placebo Comparator: Placebo<br>The Placebogroup will receive Placebo tablets daily, after breakfast and lunch, for twelve weeks. | Other: Placebo<br>* The control group will receive two placebo daily, after breakfast and lunch, for twelve weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean serum TNF-alpha concentration | Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit | 12 weeks | 
| Mean serum IL-6 concentration | Human Interleukin 6, IL-6 ELISA Kit | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Serum FBS concentration | Glucose Test Kit | 12 weeks | 
| Mean HbA1C Serum | Human Hemoglobin A1c (HbA1c) Assay Kit | 12 weeks | 
| Mean Serum Testosterone concentration | The Testosterone ELISA Kits | 12 weeks | 
| Mean Serum Estrogen concentration | The Total Estrogens ELISA Assay Kit | 12 weeks | 
| Mean Serum Adiponectin concentration | Adiponectin Human ELISA Kit | 12 weeks | 
| Mean Serum IGF1 concentration | IGF-1 ELISA Assay Kit | 12 weeks | 
| Mean Serum SHBG concentration | liquid chromatography-tandem mass spectrometry | 12 weeks | 
| Mean Serum FSH concentration | FSH (Human) ELISA Kit | 12 weeks | 
| Mean Serum LH concentration | LH (Human) ELISA Kit | 12 weeks | 
| Mean Serum Progesterone concentration | The Progesterone Enzyme Immunoassay Kit | 12 weeks | 
| Mean plasma total antioxidant capacity concentration | Total Antioxidant Capacity ELISA Kit | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quercetin, Endometriosis, Inflammation, Gonadal Steroid Hormones, Anthropometric, Adiponectin, Growth factor, Metabolic factors