Effect of Quercetin Supplementation on Endometriosis Outcomes

August 15, 2023 updated by: Ghazaleh Eslamian, National Nutrition and Food Technology Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quercetin
The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.
Dietary supplement: Quercetin
The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.
Placebo Comparator: Placebo
The Placebogroup will receive Placebo 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Ghazaleh Eslamian, PhD, National Nutrition and Food Technology Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43003154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

One year after starting the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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