Effect of Quercetin Supplementation on Endometriosis Outcomes

NCT ID: NCT05983224

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2024-03-01

Brief Summary

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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

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Quercetin

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

Group Type EXPERIMENTAL

Quercetin

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Quercetin

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Ghazaleh Eslamian

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ghazaleh Eslamian, PhD

Role: PRINCIPAL_INVESTIGATOR

National Nutrition and Food Technology Research Institute

Locations

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National Nutrition and Food Technology Research Institute

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Ghazaleh Eslamian, PhD

Role: CONTACT

+989122173918

Facility Contacts

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Ghazaleh Eslamian, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30062709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29105398 (View on PubMed)

Other Identifiers

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43003154

Identifier Type: -

Identifier Source: org_study_id

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