Effect of Quercetin Supplementation on Endometriosis Outcomes

NCT05983224 | Unknown DMC

• 1 other identifier: 43003154
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Quercetin; Endometriosis; Inflammation; Gonadal Steroid Hormones; Anthropometric; Adiponectin; Growth factor; Metabolic factors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Mean Serum FBS concentration

  12 weeks

• Mean HbA1C Serum

  12 weeks

• Mean Serum Testosterone concentration

  12 weeks

• Mean Serum Estrogen concentration

  12 weeks

• Mean Serum Adiponectin concentration

  12 weeks

Study Arms (2)

Quercetin

EXPERIMENTAL

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

Dietary Supplement: Quercetin

Placebo

PLACEBO COMPARATOR

The Placebogroup will receive Placebo tablets daily, after breakfast and lunch, for twelve weeks.

Other: Placebo

Interventions

Quercetin DIETARY_SUPPLEMENT

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

Quercetin

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran

RECRUITING

Related 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.

  PMID: 30062709 BACKGROUND

• 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.

  PMID: 29105398 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Inflammation

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ghazaleh Eslamian, PhD

  National Nutrition and Food Technology Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghazaleh Eslamian, PhD

CONTACT

+989122173918; gh_eslamian@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 9, 2023
• Study Start: August 15, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after starting the study

Locations

IR (1)