About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Anti-Inflammatory Dietary Intervention
BehavioralA 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
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in Mediterranean Diet Quality Index for Children and Adolescents (KIDMED) Score
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.
Secondary outcomes
Change in Menstrual Pain Intensity Assessed Using a Visual Analogue Scale
Menstrual pain intensity will be assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater menstrual pain intensity. Change from baseline to post-intervention will be compared between the study arms.
Change in Premenstrual Symptom Severity Assessed Using the Premenstrual Symptoms Screening Tool
Premenstrual symptoms will be assessed using the Premenstrual Symptoms Screening Tool (PSST). The instrument evaluates 14 premenstrual symptoms and five areas of functional impairment. Each item is rated from 0 (not at all) to 3 (severe), giving a total score ranging from 0 to 57. Higher scores indicate greater severity of premenstrual symptoms and related functional impairment. Change from baseline to post-intervention will be compared between the study arms.
Change in Self-Reported Menstrual Cycle Regularity
Menstrual cycle regularity will be assessed during a medical interview based on self-reported menstrual cycle characteristics, including usual cycle length and variability in cycle length. The assessment will be performed before and after the intervention. Changes in menstrual cycle regularity from baseline to post-intervention will be compared between the study arms.
Change in Body Mass Index
Body weight will be measured in kilograms and height in metres. Body mass index (BMI) will be calculated as body weight divided by height squared and expressed in kilograms per square metre (kg/m²). Change in BMI from baseline to post-intervention will be compared between the study arms.
Other outcomes
Change in Total Physical Activity Assessed Using the International Physical Activity Questionnaire
Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). The questionnaire evaluates walking and moderate- and vigorous-intensity physical activity performed during the previous seven days. Total physical activity will be expressed as metabolic equivalent minutes per week (MET-minutes/week), calculated according to the IPAQ scoring protocol. Higher values indicate a higher level of physical activity. Change from baseline to post-intervention will be compared between the study arms.
Change in Selected Salivary Estrogen Concentration
Salivary estrogen concentration will be assessed before and after the intervention. The outcome is the change in salivary estrogen concentration from baseline to immediately after the 16-week intervention.
Change in Salivary Testosterone Concentration
Salivary testosterone concentration will be assessed before and after the intervention. The outcome is the change in salivary testosterone concentration from baseline to immediately after the 16-week intervention.
Change in Salivary Progesterone Concentration
Salivary progesterone concentration will be assessed before and after the intervention. The outcome is the change in salivary progesterone concentration from baseline to immediately after the 16-week intervention.
Sponsors and contacts
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Poznan University of Physical Education
Lead sponsor
Ministry of Science and Higher Education, Poland
Collaborator