NCT07072936

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
Last Updated

July 18, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 20, 2025

Last Update Submit

July 9, 2025

Conditions

Infertility FemaleZonulinIntestinal PermeabilityMediterranean Diet

Keywords

female infertilityserum zonulinmediterranean dietclinical pregnancy

Outcome Measures

Primary Outcomes (1)

  • intestinal permeability

    serum zonulin levels

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • infertility outcomes

    From enrollment to the end of treatment at 8 weeks

  • infertility outcomes

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

mediterranean diet group

EXPERIMENTAL

this group will apply mediterranean diet for 8 weeks

Behavioral: mediterranean diet

control group

NO INTERVENTION

this group will apply routine diet for 8 weeks

Interventions

mediterranean dietBEHAVIORAL

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.

mediterranean diet group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen (research focussed on female infertility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovaArt

Ankara, Ankara, 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 20, 2025

First Posted

July 18, 2025

Study Start

February 10, 2024

Primary Completion

May 20, 2024

Study Completion

August 30, 2024

Last Updated

July 18, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)

Locations

TU(1)