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OpenTrials
Completed

NCT Number: NCT07072936

Effect Of The Mediterranean Diet On Zonulin And 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

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Key information

Conditions

Infertility Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Intestinal Permeability Mediterranean Diet Urogenital Diseases Zonulin

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NovaArt

Ankara, 06810, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being in the range of 18.5-29.9 kg/m2 BMI
  • Having started infertility treatment

Exclusion criteria

  • Having a chronic disease (diabetes mellitus, hypertension, etc.)
  • Previous ovarian surgery
  • Being diagnosed with PCOS, endometriosis
  • Known autoimmune disease
  • Thyroid disease

Treatment and study plan

Mediterranean Diet

Behavioral

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.

Primary outcomes

  1. intestinal permeability

    Time frame: From enrollment to the end of treatment at 8 weeks

    serum zonulin levels

Secondary outcomes

  1. infertility outcomes

    Time frame: From enrollment to the end of treatment at 8 weeks

    number of eggs collected

  2. infertility outcomes

    Time frame: From enrollment to the end of treatment at 8 weeks

    number of embryos formed

Sponsors and collaborators

Lead sponsor

SINEM BAYRAM

Other

Registry information

Official study title

Evaluation Of The Effect Of Mediterranean Diet On Serum Zonulin Levels And Treatment Success In Women Infertility

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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