An interventional study of Anti-Inflammatory Dietary Intervention and Physical Activity and Training Programme in Reproductive Health, sponsored by Poznan University of Physical Education. Recruiting at 2 sites in Poland. Open to female participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Prevention
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.
This is a two-arm, parallel, school-based interventional study involving approximately 100 girls aged 14-19 years recruited from two secondary schools in the Greater Poland region. The intervention will last 16 weeks. Participants will not be individually randomized. Each participating school will implement one of the two intervention programmes; therefore, allocation will occur at the school level for organizational reasons.
Participants in the anti-inflammatory diet group (AIDiet) will take part in a dietary education programme based on Mediterranean dietary principles. The programme will include four practical and theoretical workshops addressing anti-inflammatory food choices and their potential relevance to reproductive health. Educational materials and tools for monitoring progress will also be available through a dedicated digital platform.
Participants in the combined intervention group (AIDiet/PAT) will receive the same dietary intervention and will additionally participate in a physical activity programme consisting of two supervised exercise sessions per week for 16 weeks. The sessions will be conducted by a physical education teacher or trainer and adapted to the participants' age and abilities.
The primary objective is to compare changes in diet quality, assessed using the KIDMED index, between the AIDiet and AIDiet/PAT groups. Secondary objectives include evaluating changes in menstrual cycle characteristics, menstrual pain, premenstrual symptoms, physical activity, anthropometric and body composition measures, selected salivary inflammatory, oxidative stress and hormonal biomarkers, and the composition and diversity of the oral microbiome.
Medical assessments, questionnaires, anthropometric and body composition measurements, and biological sample collection will be conducted before and after the intervention. The study does not include an untreated control group because all participants will receive health education intended to support reproductive health.
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Female adolescents aged 14 to 19 years
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 16-week anti-inflammatory dietary intervention based on Mediterranean dietary principles. The programme includes dietary education, practical workshops, dietary recommendations, and access to educational materials through a dedicated digital platform. No additional physical activity programme is provided as part of this study arm.
Behavioral: Anti-Inflammatory Dietary Intervention
Participants receive a 16-week anti-inflammatory dietary intervention based on Mediterranean dietary principles and additionally participate in a physical activity programme consisting of two sessions per week. The physical activity programme is delivered by the study team in the school setting and adapted to the participants' age and abilities. Educational materials are also available through a dedicated digital platform.
Behavioral: Anti-Inflammatory Dietary Intervention · Behavioral: Physical Activity and Training Programme
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.
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.
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.
Time frame: Baseline and immediately after the 16-week intervention
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.
Time frame: Baseline and immediately after the 16-week intervention
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.
Time frame: Baseline and immediately after the 16-week intervention
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.
Time frame: Baseline and immediately after the 16-week intervention
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.
Time frame: Baseline and immediately after the 16-week intervention
Change in Body Fat Percentage
Body fat percentage will be assessed using bioelectrical impedance analysis and expressed as a percentage of total body weight. Change in body fat percentage from baseline to post-intervention will be compared between the study arms.
Time frame: Baseline and immediately after the 16-week intervention
Change in Fat-Free Mass
Fat-free mass will be assessed using bioelectrical impedance analysis and expressed in kilograms. Change in fat-free mass from baseline to post-intervention will be compared between the study arms.
Time frame: Baseline and immediately after the 16-week intervention
Change in Waist Circumference
Waist circumference will be measured according to a standardized anthropometric procedure and expressed in centimetres. Change in waist circumference from baseline to post-intervention will be compared between the study arms.
Time frame: Baseline and immediately after the 16-week intervention
Change in Systolic and Diastolic Blood Pressure
Resting systolic and diastolic blood pressure will be measured using a standardized procedure and expressed in millimetres of mercury (mmHg). Changes in systolic and diastolic blood pressure from baseline to post-intervention will be compared between the study arms.
Time frame: Baseline and immediately after the 16-week intervention
Change in Acne Severity Assessed Using the Investigator's Global Assessment
Acne severity will be evaluated using the Investigator's Global Assessment (IGA). The scale provides an overall clinical assessment of acne severity, with higher grades indicating greater severity. Change in the IGA grade from baseline to post-intervention will be compared between the study arms.
Time frame: Baseline and immediately after the 16-week intervention
Change in Hirsutism Severity Assessed Using the Modified Ferriman-Gallwey Score
Hirsutism severity will be assessed using the modified Ferriman-Gallwey score. Terminal hair growth in nine androgen-sensitive body areas is rated from 0 to 4, giving a total score ranging from 0 to 36. Higher scores indicate greater hirsutism severity. Change from baseline to post-intervention will be compared between the study arms.
Time frame: Baseline and immediately after the 16-week intervention
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.
Time frame: Baseline and immediately after the 16-week intervention
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.
Time frame: Baseline and 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.
Time frame: Baseline and 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.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Prolactin Concentration
Salivary prolactin concentration will be assessed before and after the intervention. The outcome is the change in salivary prolactin concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Cortisol Concentration
Salivary cortisol concentration will be assessed before and after the intervention. The outcome is the change in salivary cortisol concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Dehydroepiandrosterone Concentration
Salivary dehydroepiandrosterone concentration will be assessed before and after the intervention. The outcome is the change in salivary dehydroepiandrosterone concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Interleukin-17A Concentration
Salivary interleukin-17A concentration will be assessed before and after the intervention. The outcome is the change in salivary interleukin-17A concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Interleukin-1 Beta Concentration
Salivary interleukin-1 beta concentration will be assessed before and after the intervention. The outcome is the change in salivary interleukin-1 beta concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Matrix Metalloproteinase-8 Concentration
Salivary matrix metalloproteinase-8 concentration will be assessed before and after the intervention. The outcome is the change in salivary matrix metalloproteinase-8 concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Tumour Necrosis Factor Alpha Concentration
Salivary tumour necrosis factor alpha concentration will be assessed before and after the intervention. The outcome is the change in salivary tumour necrosis factor alpha concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Malondialdehyde Concentration
Salivary malondialdehyde concentration will be assessed before and after the intervention. The outcome is the change in salivary malondialdehyde concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary Total Antioxidant Capacity
Salivary total antioxidant capacity will be assessed before and after the intervention. The outcome is the change in salivary total antioxidant capacity from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Salivary 8-Hydroxy-2'-deoxyguanosine Concentration
Salivary 8-hydroxy-2'-deoxyguanosine concentration will be assessed before and after the intervention. The outcome is the change in salivary 8-hydroxy-2'-deoxyguanosine concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Secretory Immunoglobulin A
Salivary secretory immunoglobulin A concentration will be assessed before and after the intervention. The outcome is the change in salivary secretory immunoglobulin A concentration from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Oral Microbiome Composition and Diversity
Oral microbiome composition and diversity will be assessed using 16S rRNA gene sequencing. Changes from baseline to post-intervention will be compared between the study arms.
Time frame: Baseline and immediately after the 16-week intervention
Change in Decayed, Missing and Filled Teeth Index
Dental status will be assessed using the Decayed, Missing and Filled Teeth Index before and after the intervention. The outcome is the change in the index from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Plaque Index
Dental plaque will be assessed using the Plaque Index before and after the intervention. The outcome is the change in the Plaque Index from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Approximal Plaque Index
Approximal dental plaque will be assessed using the Approximal Plaque Index before and after the intervention. The outcome is the change in the Approximal Plaque Index from baseline baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Gingival Index
Gingival health will be assessed using the Gingival Index before and after the intervention. The outcome is the change in the Gingival Index from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
Change in Bleeding on Probing
Gingival bleeding will be assessed using bleeding on probing before and after the intervention. The outcome is the change in bleeding on probing from baseline to immediately after the 16-week intervention.
Time frame: Baseline and immediately after the 16-week intervention
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Poznan University of Physical Education