Effect of Quercetin Supplementation on Endometriosis Outcomes

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983224
• Other study ID #: 43003154
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2023
• Source: National Nutrition and Food Technology Institute
• Contact: Ghazaleh Eslamian, PhD
• Phone: +989122173918
• Email: gh_eslamian[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Dietary Supplement:
• Quercetin
The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.

Other:
• Placebo
The control group will receive two placebo daily, after breakfast and lunch, for twelve weeks.

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute	Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

Khorshidi M, Moini A, Alipoor E, Rezvan N, Gorgani-Firuzjaee S, Yaseri M, Hosseinzadeh-Attar MJ. The effects of quercetin supplementation on metabolic and hormonal parameters as well as plasma concentration and gene expression of resistin in overweight or obese women with polycystic ovary syndrome. Phytother Res. 2018 Nov;32(11):2282-2289. doi: 10.1002/ptr.6166. Epub 2018 Jul 30. — View Citation

Rezvan N, Moini A, Gorgani-Firuzjaee S, Hosseinzadeh-Attar MJ. Oral Quercetin Supplementation Enhances Adiponectin Receptor Transcript Expression in Polycystic Ovary Syndrome Patients: A Randomized Placebo-Controlled Double-Blind Clinical Trial. Cell J. 2018 Jan;19(4):627-633. doi: 10.22074/cellj.2018.4577. Epub 2017 Nov 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean serum TNF-alpha concentration	Human Tumor Necrosis Factor ?lpha, TNF-A ELISA Kit	12 weeks
Primary	Mean serum IL-6 concentration	Human Interleukin 6, IL-6 ELISA Kit	12 weeks
Secondary	Mean Serum FBS concentration	Glucose Test Kit	12 weeks
Secondary	Mean HbA1C Serum	Human Hemoglobin A1c (HbA1c) Assay Kit	12 weeks
Secondary	Mean Serum Testosterone concentration	The Testosterone ELISA Kits	12 weeks
Secondary	Mean Serum Estrogen concentration	The Total Estrogens ELISA Assay Kit	12 weeks
Secondary	Mean Serum Adiponectin concentration	Adiponectin Human ELISA Kit	12 weeks
Secondary	Mean Serum IGF1 concentration	IGF-1 ELISA Assay Kit	12 weeks
Secondary	Mean Serum SHBG concentration	liquid chromatography-tandem mass spectrometry	12 weeks
Secondary	Mean Serum FSH concentration	FSH (Human) ELISA Kit	12 weeks
Secondary	Mean Serum LH concentration	LH (Human) ELISA Kit	12 weeks
Secondary	Mean Serum Progesterone concentration	The Progesterone Enzyme Immunoassay Kit	12 weeks
Secondary	Mean plasma total antioxidant capacity concentration	Total Antioxidant Capacity ELISA Kit	12 weeks