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Effect of Quercetin Supplementation on Endometriosis Outcomes

Primary Purpose

Endometriosis

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Quercetin
Placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis focused on measuring Quercetin, Endometriosis, Inflammation, Gonadal Steroid Hormones, Anthropometric, Adiponectin, Growth factor, Metabolic factors

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Nutrition and Food Technology Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Quercetin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean serum TNF-alpha concentration
Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit
Mean serum IL-6 concentration
Human Interleukin 6, IL-6 ELISA Kit

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2023
Last Updated
August 15, 2023
Sponsor
National Nutrition and Food Technology Institute
Collaborators
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05983224
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute
Collaborators
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Quercetin, Endometriosis, Inflammation, Gonadal Steroid Hormones, Anthropometric, Adiponectin, Growth factor, Metabolic factors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quercetin
Arm Type
Experimental
Arm Description
The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The Placebogroup will receive Placebo tablets daily, after breakfast and lunch, for twelve weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin
Intervention Description
The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The control group will receive two placebo daily, after breakfast and lunch, for twelve weeks.
Primary Outcome Measure Information:
Title
Mean serum TNF-alpha concentration
Description
Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit
Time Frame
12 weeks
Title
Mean serum IL-6 concentration
Description
Human Interleukin 6, IL-6 ELISA Kit
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean Serum FBS concentration
Description
Glucose Test Kit
Time Frame
12 weeks
Title
Mean HbA1C Serum
Description
Human Hemoglobin A1c (HbA1c) Assay Kit
Time Frame
12 weeks
Title
Mean Serum Testosterone concentration
Description
The Testosterone ELISA Kits
Time Frame
12 weeks
Title
Mean Serum Estrogen concentration
Description
The Total Estrogens ELISA Assay Kit
Time Frame
12 weeks
Title
Mean Serum Adiponectin concentration
Description
Adiponectin Human ELISA Kit
Time Frame
12 weeks
Title
Mean Serum IGF1 concentration
Description
IGF-1 ELISA Assay Kit
Time Frame
12 weeks
Title
Mean Serum SHBG concentration
Description
liquid chromatography-tandem mass spectrometry
Time Frame
12 weeks
Title
Mean Serum FSH concentration
Description
FSH (Human) ELISA Kit
Time Frame
12 weeks
Title
Mean Serum LH concentration
Description
LH (Human) ELISA Kit
Time Frame
12 weeks
Title
Mean Serum Progesterone concentration
Description
The Progesterone Enzyme Immunoassay Kit
Time Frame
12 weeks
Title
Mean plasma total antioxidant capacity concentration
Description
Total Antioxidant Capacity ELISA Kit
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghazaleh Eslamian, PhD
Phone
+989122173918
Email
gh_eslamian@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazaleh Eslamian, PhD
Organizational Affiliation
National Nutrition and Food Technology Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghazaleh Eslamian, PhD
Email
gh_eslamian@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
One year after starting the study
Citations:
PubMed Identifier
30062709
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.
Results Reference
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PubMed Identifier
29105398
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.
Results Reference
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Effect of Quercetin Supplementation on Endometriosis Outcomes

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