Anti-Inflammatory Diet and Exercise for Reproductive Health in Adolescent Girls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, school-based interventional study enrolling about 100 female adolescents from two Polish secondary schools. One group receives a Mediterranean-based anti-inflammatory dietary program, while the other group receives the same diet plus twice-weekly supervised physical activity for 16 weeks. The primary outcome is change in diet quality measured by the KIDMED index; secondary outcomes include menstrual characteristics, pain, premenstrual symptoms, physical activity, body composition, anthropometrics, selected salivary biomarkers, and oral microbiome profiles. Participants are assigned by school, not individually randomized, to facilitate implementation. Assessments are conducted before and after the intervention to evaluate potential benefits on reproductive health indicators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Female adolescents aged 14 to 19 years

* Attendance at one of the participating secondary schools
* Provision of written informed consent by the participant and, for participants below the age of legal consent, by a parent or legal guardian
* Willingness to participate in the study assessments and the assigned 16-week intervention

Exclusion Criteria:

* Presence of systemic or hereditary diseases Thyroid dysfunction, diabetes mellitus, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of a pituitary adenoma, or an androgen-secreting tumour.
* Severe salivary gland dysfunction, including Sjögren syndrome
* Chronic use of medications, hormonal therapy, antibiotic treatment, or regular use of dietary supplements with potential effects on hormonal, inflammatory, oxidative stress, or microbiome-related outcomes within the previous three months.
* Regular alcohol consumption or tobacco smoking
* Allergy to olive oil, nuts, legumes, spices, or herbs
* Medical contraindications to physical exercise or participation in the training programme.

Participants with acute oral infections, gingival bleeding, or other oral conditions affecting the reliability of oral microbiome assessments may remain eligible for the other study assessments but will not be included in the relevant oral microbiome analyses.

Where it's running

• Liceum Ogólnokształcące Św. Marii Magdaleny
  Poznan, Greater Poland Voivodeship, Poland Recruiting
• Liceum Ogólnokształące im. Powstanców Wielkopolskich
  Środa Wielkopolska, Greater Poland Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Małgorzata Mizgier — Poznan University of Physical Education
• Study coordinator: Małgorzata Mizgier, PhD, DSc
• Email: mizgier@awf.poznan.pl
• Phone: +48 61 835 50 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.