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

NCT07834489 · tracked via the Priya Life Science Poland tracker

Sponsor

Poznan University of Physical Education

Phase

Not applicable

Started

2026-10-20

Last updated

2026-09-22

Condition(s) studied

Reproductive Health

Investigational drug(s) / intervention(s)

Anti-Inflammatory Dietary InterventionPhysical Activity and Training Programme

Anti-Inflammatory Dietary Intervention: 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: 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.

Study summary

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.

Eligibility

Sex

FEMALE

Min age

14 Years

Max age

19 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Change in Mediterranean Diet Quality Index for Children and Adolescents (KIDMED) Score — Baseline and immediately after the 16-week intervention
Diet quality will be assessed using the 16-item Mediterranean Diet Quality Index for Children and Adolescents (KIDMED). Positively scored items receive +1 point and negatively scored items receive -1 point, giving a total score ranging from -4 to 12. Higher scores indicate better adherence to a Mediterranean dietary pattern. Change from baseline to post-intervention will be compared between the study arms.

Trial sites (2)

Facility	City	Region	Status
Liceum Ogólnokształcące Św. Marii Magdaleny	Poznan	Greater Poland Voivodeship	Recruiting
Liceum Ogólnokształące im. Powstanców Wielkopolskich	Środa Wielkopolska	Greater Poland Voivodeship	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07834489 on ClinicalTrials.gov ↗ ← All trials in Poland