Effect of Quercetin Supplementation on Endometriosis Outcomes

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05983224

Collaborator

Shahid Beheshti University of Medical Sciences (Other)

Enrollment

Location

Arms

6.5

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Dietary Supplement: Quercetin Other: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mean serum TNF-alpha concentration [12 weeks]
Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit
Mean serum IL-6 concentration [12 weeks]
Human Interleukin 6, IL-6 ELISA Kit

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.