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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05983224
Other study ID # 43003154
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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