Clinical trial NCT05983224: Effect of Quercetin Supplementation on Endometriosis Outcomes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Quercetin
Endometriosis
Inflammation
Gonadal Steroid Hormones
Anthropometric
Adiponectin
Growth factor
Metabolic factors
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2023-08-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Mean serum TNF-alpha concentration
timeFrame: 12 weeks
measure: Mean serum IL-6 concentration
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean Serum FBS concentration
timeFrame: 12 weeks
measure: Mean HbA1C Serum
timeFrame: 12 weeks
measure: Mean Serum Testosterone concentration
timeFrame: 12 weeks
measure: Mean Serum Estrogen concentration
timeFrame: 12 weeks
measure: Mean Serum Adiponectin concentration
timeFrame: 12 weeks
measure: Mean Serum IGF1 concentration
timeFrame: 12 weeks
measure: Mean Serum SHBG concentration
timeFrame: 12 weeks
measure: Mean Serum FSH concentration
timeFrame: 12 weeks
measure: Mean Serum LH concentration
timeFrame: 12 weeks
measure: Mean Serum Progesterone concentration
timeFrame: 12 weeks
measure: Mean plasma total antioxidant capacity concentration
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
affiliation: National Nutrition and Food Technology Research Institute
name: Ghazaleh Eslamian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.