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RECRUITING Not applicable ClinicalTrials.gov

Anti-Inflammatory Diet and Physical Activity for Reproductive Health in Adolescent Girls

Sponsor: Poznan University of Physical Education • ClinicalTrials.gov ID: NCT07834489

Registry updated: 2026-09-22
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Description

This study will evaluate whether a 16-week anti-inflammatory dietary intervention, delivered alone or together with a physical activity programme, can improve diet quality and support reproductive health in girls aged 14-19 years. Approximately 100 participants will be recruited from two secondary schools in Poland. Participants at both schools will receive education and practical guidance on an anti-inflammatory diet based on Mediterranean dietary principles. Participants at one school will additionally take part in a supervised physical activity programme conducted twice weekly. The primary outcome will be the change in diet quality assessed using the KIDMED index. Additional assessments will examine menstrual health, premenstrual symptoms, menstrual pain, physical activity, body composition, anthropometric measures, selected salivary biomarkers, and the oral microbiome. Assessments will be conducted before and after the intervention.

Interventions

  • Anti-Inflammatory Dietary Intervention (Behavioral)
    A 16-week dietary education and behavior-change programme based on Mediterranean dietary principles. The intervention includes four theoretical and practical workshops, dietary recommendations, and educational materials provided through a dedicated digital platform. Participants are encouraged to increase their consumption of vegetables, fruit, whole grains, legumes, fish, nuts, olive oil, herbs, and spices and to limit red meat and sweets. The intervention does not include energy restriction.
  • Physical Activity and Training Programme (Behavioral)
    A 16-week physical activity programme consisting of two sessions per week. The sessions are delivered by the study team in the school setting and are adapted to the participants' age and abilities. Educational materials related to physical activity are also available through a dedicated digital platform.

Eligibility criteria

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.

Conditions

Reproductive Health

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record