EndometriosisNCT05983224
Effect of Quercetin Supplementation on Endometriosis Outcomes
A study testing Quercetin in people with Endometriosis, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Quercetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 15 Aug 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
National Nutrition and Food Technology Research Institute
Tehran
Ghazaleh Eslamian, PhD, gh_eslamian@yahoo.com
About this study
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
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.
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Quercetin, Placebo
- Keywords
- Quercetin, Endometriosis, Inflammation, Gonadal Steroid Hormones, Anthropometric, Adiponectin, Growth factor, Metabolic factors
- Medical subject headings
- Endometriosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDietary supplement
The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks.
PlaceboOther
The control group will receive two placebo daily, after breakfast and lunch, for twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| Quercetin | Experimental | The intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks. Receives: Dietary Supplement: Quercetin |
| Placebo | Placebo comparator | The Placebogroup will receive Placebo tablets daily, after breakfast and lunch, for twelve weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean serum TNF-alpha concentration
Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit
Measured: 12 weeks
Mean serum IL-6 concentration
Human Interleukin 6, IL-6 ELISA Kit
Measured: 12 weeks
Secondary outcomes (11)
Mean Serum FBS concentration
Glucose Test Kit
Measured: 12 weeks
Mean HbA1C Serum
Human Hemoglobin A1c (HbA1c) Assay Kit
Measured: 12 weeks
Mean Serum Testosterone concentration
The Testosterone ELISA Kits
Measured: 12 weeks
Mean Serum Estrogen concentration
The Total Estrogens ELISA Assay Kit
Measured: 12 weeks
Mean Serum Adiponectin concentration
Adiponectin Human ELISA Kit
Measured: 12 weeks
Mean Serum IGF1 concentration
IGF-1 ELISA Assay Kit
Measured: 12 weeks
Mean Serum SHBG concentration
liquid chromatography-tandem mass spectrometry
Measured: 12 weeks
Mean Serum FSH concentration
FSH (Human) ELISA Kit
Measured: 12 weeks
Mean Serum LH concentration
LH (Human) ELISA Kit
Measured: 12 weeks
Mean Serum Progesterone concentration
The Progesterone Enzyme Immunoassay Kit
Measured: 12 weeks
Mean plasma total antioxidant capacity concentration
Total Antioxidant Capacity ELISA Kit
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start15 Aug 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Ghazaleh Eslamian, National Nutrition and Food Technology Institute
- Investigators
- Ghazaleh Eslamian, PhD, Principal investigator, National Nutrition and Food Technology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983224
- Sponsor's protocol ID
- 43003154
- Status last verified
- Aug 2023
- First submitted
- 24 Jul 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30062709Rezvan 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.
PubMed 29105398
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05983224
- Acronym / sponsor ID
- 43003154
- Conditions
- Endometriosis
- Keywords
- Quercetin, Endometriosis, Inflammation, Gonadal Steroid Hormones, Anthropometric, Adiponectin, Growth factor, Metabolic factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quercetin | Experimental | Dietary Supplement: QuercetinThe intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks. |
| Placebo | Placebo comparator | Other: PlaceboThe Placebogroup will receive Placebo tablets daily, after breakfast and lunch, for twelve weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuercetinThe intervention group will receive two 500 mg quercetin tablets daily, after breakfast and lunch, for twelve weeks. | Dietary supplement | Quercetin |
| PlaceboThe control group will receive two placebo daily, after breakfast and lunch, for twelve weeks. | Other | Placebo |
Primary outcome
Mean serum TNF-alpha concentration
Time frame: 12 weeks
Human Tumor Necrosis Factor Αlpha, TNF-A ELISA Kit
Mean serum IL-6 concentration
Time frame: 12 weeks
Human Interleukin 6, IL-6 ELISA Kit
11 secondary outcomes
Mean Serum FBS concentration
Time frame: 12 weeks
Mean HbA1C Serum
Time frame: 12 weeks
Mean Serum Testosterone concentration
Time frame: 12 weeks
Mean Serum Estrogen concentration
Time frame: 12 weeks
Mean Serum Adiponectin concentration
Time frame: 12 weeks
Mean Serum IGF1 concentration
Time frame: 12 weeks
Mean Serum SHBG concentration
Time frame: 12 weeks
Mean Serum FSH concentration
Time frame: 12 weeks
Mean Serum LH concentration
Time frame: 12 weeks
Mean Serum Progesterone concentration
Time frame: 12 weeks
Mean plasma total antioxidant capacity concentration
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 30062709Khorshidi 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.
- Background: PubMed 29105398Rezvan 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghazaleh Eslamian, PhD principal investigator
National Nutrition and Food Technology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin in people with Endometriosis, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghazaleh Eslamian, PhD (+989122173918, gh_eslamian@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean serum TNF-alpha concentration (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05983224, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.