Infertility FemaleNCT07072936
Effect Of The Mediterranean Diet On Zonulin And Infertility
A study testing mediterranean diet in people with Infertility Female and Zonulin, run by SINEM BAYRAM at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if mediterranean diet works to treat infertility in women. It will also learn about the initial and end of study zonulin levels of mediterranean diet and control group. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility Female, Zonulin, Intestinal Permeability
- What is being tested?
- mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2024to 30 Aug 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being in the range of 18.5-29.9 kg/m2 BMI
- Having started infertility treatment
Who cannot join
- Having a chronic disease (diabetes mellitus, hypertension, etc.)
- Previous ovarian surgery
- Being diagnosed with PCOS, endometriosis
- Known autoimmune disease
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of The Effect Of Mediterranean Diet On Serum Zonulin Levels And Treatment Success In Women Infertility
The goal of this clinical trial is to learn if mediterranean diet works to treat infertility in women. It will also learn about the initial and end of study zonulin levels of mediterranean diet and control group. The main questions it aims to answer are:
- Does mediterranean diet lower the serum zonulin levels of participants?
- Does mediterranean diet improves the treatment success of participants with infertility? Researchers will compare mediterranean to a control group to see if diet works to treat infertility.
Participants will:
- Apply Mediterranean diet or routine diet without energy restriction for 8 weeks
- Visit the clinic once every 4 weeks for checkups and tests
- Being tested
- mediterranean diet
- Keywords
- female infertility, serum zonulin, mediterranean diet, clinical pregnancy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mediterranean dietBehavioural
All questions of the intervention group, in which behavioural change was expected, were answered by the dietitian throughout the study and compliance with the diet was monitored with food consumption records.
| Study group | Role | What they receive |
|---|---|---|
| mediterranean diet group | Experimental | this group will apply mediterranean diet for 8 weeks Receives: Behavioral: mediterranean diet |
| control group | No intervention | this group will apply routine diet for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal permeability
serum zonulin levels
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
infertility outcomes
number of eggs collected
Measured: From enrollment to the end of treatment at 8 weeks
infertility outcomes
number of embryos formed
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start10 Feb 2024
- Primary completion20 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility FemaleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- SINEM BAYRAM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SINEM BAYRAM, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072936
- Sponsor's protocol ID
- SINEM BAYRAM
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest on infertility. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effect Of Mediterranean Diet On Serum Zonulin Levels And Treatment Success In Women Infertility
- ClinicalTrials.gov ID
- NCT07072936
- Acronym / sponsor ID
- SINEM BAYRAM
- Keywords
- female infertility, serum zonulin, mediterranean diet, clinical pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SINEM BAYRAMUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 18 Jul 2025 (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.
The goal of this clinical trial is to learn if mediterranean diet works to treat infertility in women. It will also learn about the initial and end of study zonulin levels of mediterranean diet and control group. The main questions it aims to answer are:
- Does mediterranean diet lower the serum zonulin levels of participants?
- Does mediterranean diet improves the treatment success of participants with infertility? Researchers will compare mediterranean to a control group to see if diet works to treat infertility.
Participants will:
- Apply Mediterranean diet or routine diet without energy restriction for 8 weeks
- Visit the clinic once every 4 weeks for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mediterranean diet group | Experimental | Behavioral: mediterranean dietthis group will apply mediterranean diet for 8 weeks |
| control group | No intervention | –this group will apply routine diet for 8 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being in the range of 18.5-29.9 kg/m2 BMI
- Having started infertility treatment
Key exclusion criteria (5 listed)
- Having a chronic disease (diabetes mellitus, hypertension, etc.)
- Previous ovarian surgery
- Being diagnosed with PCOS, endometriosis
- Known autoimmune disease
- Thyroid disease
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 |
|---|---|---|
| mediterranean dietAll questions of the intervention group, in which behavioural change was expected, were answered by the dietitian throughout the study and compliance with the diet was monitored with food consumption records. | Behavioural | mediterranean diet group |
Primary outcome
intestinal permeability
Time frame: From enrollment to the end of treatment at 8 weeks
serum zonulin levels
2 secondary outcomes
infertility outcomes
Time frame: From enrollment to the end of treatment at 8 weeks
infertility outcomes
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest on infertility. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Related trials for Infertility Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mediterranean diet in people with Infertility Female and Zonulin, run by SINEM BAYRAM at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jul 2025. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal permeability (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.