[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657083":3},{"organization":4,"outcomesModule":7,"designInfo":108,"detailedDescription":116,"studyPopulation":113,"armGroups":117,"interventions":130,"overallOfficials":140,"centralContacts":144,"locations":150,"responsibleParty":178,"collaborators":180,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":192,"sex":193,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":113,"studyType":199,"phases":200,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":153,"whyStopped":113,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"Poznan University of Physical Education","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline and immediately after the 16-week intervention",[14,17,20,23,26,29,32,35,38,41],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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\u002Fm²). Change in BMI from baseline to post-intervention will be compared between the study arms.",{"measure":27,"description":28,"timeFrame":12},"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.",{"measure":30,"description":31,"timeFrame":12},"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.",{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":37,"timeFrame":12},"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.",{"measure":39,"description":40,"timeFrame":12},"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.",{"measure":42,"description":43,"timeFrame":12},"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.",[45,48,51,54,57,60,63,66,69,72,75,78,81,84,87,90,93,96,99,102,105],{"measure":46,"description":47,"timeFrame":12},"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\u002Fweek), 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.",{"measure":49,"description":50,"timeFrame":12},"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.",{"measure":52,"description":53,"timeFrame":12},"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.",{"measure":55,"description":56,"timeFrame":12},"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.",{"measure":58,"description":59,"timeFrame":12},"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.",{"measure":61,"description":62,"timeFrame":12},"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.",{"measure":64,"description":65,"timeFrame":12},"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.",{"measure":67,"description":68,"timeFrame":12},"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.",{"measure":70,"description":71,"timeFrame":12},"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.",{"measure":73,"description":74,"timeFrame":12},"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.",{"measure":76,"description":77,"timeFrame":12},"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.",{"measure":79,"description":80,"timeFrame":12},"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.",{"measure":82,"description":83,"timeFrame":12},"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.",{"measure":85,"description":86,"timeFrame":12},"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.",{"measure":88,"description":89,"timeFrame":12},"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.",{"measure":91,"description":92,"timeFrame":12},"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.",{"measure":94,"description":95,"timeFrame":12},"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.",{"measure":97,"description":98,"timeFrame":12},"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.",{"measure":100,"description":101,"timeFrame":12},"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.",{"measure":103,"description":104,"timeFrame":12},"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.",{"measure":106,"description":107,"timeFrame":12},"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.",{"allocation":109,"interventionModel":110,"interventionModelDescription":111,"primaryPurpose":112,"observationalModel":113,"timePerspective":113,"maskingInfo":114},"NON_RANDOMIZED","PARALLEL","Two-arm, parallel, non-randomized study. Intervention assignment is based on the recruitment site. Both interventions are delivered by the study team in the school setting.","PREVENTION",null,{"masking":115,"maskingDescription":113,"whoMasked":113},"NONE","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.\n\nParticipants 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.\n\nParticipants in the combined intervention group (AIDiet\u002FPAT) 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.\n\nThe primary objective is to compare changes in diet quality, assessed using the KIDMED index, between the AIDiet and AIDiet\u002FPAT 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.\n\nMedical 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.",[118,124],{"label":119,"type":120,"description":121,"interventionNames":122},"Anti-Inflammatory Diet (AIDiet)","ACTIVE_COMPARATOR","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.",[123],"Behavioral: Anti-Inflammatory Dietary Intervention",{"label":125,"type":126,"description":127,"interventionNames":128},"Anti-Inflammatory Diet Plus Physical Activity and Training (AIDiet\u002FPAT)","EXPERIMENTAL","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.",[123,129],"Behavioral: Physical Activity and Training Programme",[131,136],{"type":132,"name":133,"description":134,"armGroupLabels":135,"otherNames":113},"BEHAVIORAL","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.",[119,125],{"type":132,"name":137,"description":138,"armGroupLabels":139,"otherNames":113},"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.",[125],[141],{"name":142,"affiliation":5,"role":143},"Małgorzata Mizgier","PRINCIPAL_INVESTIGATOR",[145],{"name":146,"role":147,"phone":148,"phoneExt":113,"email":149},"Małgorzata Mizgier, PhD, DSc","CONTACT","+48 61 835 50 00","mizgier@awf.poznan.pl",[151,167],{"facility":152,"status":153,"city":154,"state":155,"zip":156,"country":157,"countryCode":158,"cosmosGeoPoint":159,"geoPoint":164,"contacts":165},"Liceum Ogólnokształcące Św. Marii Magdaleny","RECRUITING","Poznan","Greater Poland Voivodeship","61-867","Poland","PL",{"type":160,"coordinates":161},"Point",[162,163],16.92993,52.40692,{"lat":163,"lon":162},[166],{"name":142,"role":147,"phone":113,"phoneExt":113,"email":149},{"facility":168,"status":153,"city":169,"state":155,"zip":170,"country":157,"countryCode":158,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Liceum Ogólnokształące im. Powstanców Wielkopolskich","Środa Wielkopolska","63-000",{"type":160,"coordinates":172},[173,174],17.27617,52.22843,{"lat":174,"lon":173},[177],{"name":142,"role":147,"phone":113,"phoneExt":113,"email":149},{"type":179,"investigatorFullName":113,"investigatorTitle":113,"investigatorAffiliation":113,"oldNameTitle":113,"oldOrganization":113},"SPONSOR",[181],{"name":182,"class":183},"Ministry of Science and Higher Education, Poland","OTHER_GOV","100657083","anti-inflammatory-diet-and-physical-activity-for-reproductive-health-in-adolescent-girls-100657083",false,"NCT07834489","Anti-Inflammatory Diet and Physical Activity for Reproductive Health in Adolescent Girls","A School-Based Anti-Inflammatory Dietary Intervention With or Without a Physical Activity Programme to Support Reproductive Health in Adolescent Girls","4fertil","Inclusion Criteria:\n\nFemale adolescents aged 14 to 19 years\n\n* Attendance at one of the participating secondary schools\n* Provision of written informed consent by the participant and, for participants below the age of legal consent, by a parent or legal guardian\n* Willingness to participate in the study assessments and the assigned 16-week intervention\n\nExclusion Criteria:\n\n* 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.\n* Severe salivary gland dysfunction, including Sjögren syndrome\n* 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.\n* Regular alcohol consumption or tobacco smoking\n* Allergy to olive oil, nuts, legumes, spices, or herbs\n* Medical contraindications to physical exercise or participation in the training programme.\n\nParticipants 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.",true,"FEMALE","14 Years","19 Years",{"count":197,"type":198},100,"ESTIMATED","INTERVENTIONAL",[201],"NA","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.\n\nThe 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.",[204],"Reproductive Health",[206,207,208,209,210,211,212,213,214,215],"Anti-Inflammatory Diet","Mediterranean Diet","Physical Activity","Diet Quality","Menstrual Health","Premenstrual Symptoms","Menstrual Pain","KIDMED","Salivary Biomarkers","Oral Microbiome","2026-09-16",{"date":218,"type":219},"2026-09-22","ACTUAL",{"date":221,"type":198},"2026-10-20",{"date":223,"type":198},"2027-06-30",{"name":5,"class":6},2]