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NCT Number: NCT07834489

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

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.

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Key information

Conditions

Reproductive Health Behavior Dysmenorrhea Menstruation Disturbances Motor Activity Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Liceum Ogólnokształcące Św. Marii Magdaleny, Poznan, Greater Poland Voivodeship, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Mediterranean Diet Quality Index for Children and Adolescents (KIDMED) Score

    Time frame: 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.

Secondary outcomes

  1. Change in Menstrual Pain Intensity Assessed Using a Visual Analogue Scale

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  2. Change in Premenstrual Symptom Severity Assessed Using the Premenstrual Symptoms Screening Tool

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  3. Change in Self-Reported Menstrual Cycle Regularity

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  4. Change in Body Mass Index

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  5. Change in Body Fat Percentage

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  6. Change in Fat-Free Mass

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  7. Change in Waist Circumference

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  8. Change in Systolic and Diastolic Blood Pressure

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  9. Change in Acne Severity Assessed Using the Investigator's Global Assessment

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  10. Change in Hirsutism Severity Assessed Using the Modified Ferriman-Gallwey Score

    Time frame: Baseline and immediately after the 16-week intervention

    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.

Other outcomes

  1. Change in Total Physical Activity Assessed Using the International Physical Activity Questionnaire

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  2. Change in Selected Salivary Estrogen Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  3. Change in Salivary Testosterone Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  4. Change in Salivary Progesterone Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  5. Change in Salivary Prolactin Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  6. Change in Salivary Cortisol Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  7. Change in Salivary Dehydroepiandrosterone Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  8. Change in Salivary Interleukin-17A Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  9. Change in Salivary Interleukin-1 Beta Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  10. Change in Salivary Matrix Metalloproteinase-8 Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  11. Change in Salivary Tumour Necrosis Factor Alpha Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  12. Change in Salivary Malondialdehyde Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  13. Change in Salivary Total Antioxidant Capacity

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  14. Change in Salivary 8-Hydroxy-2'-deoxyguanosine Concentration

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  15. Secretory Immunoglobulin A

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  16. Change in Oral Microbiome Composition and Diversity

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  17. Change in Decayed, Missing and Filled Teeth Index

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  18. Change in Plaque Index

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  19. Change in Approximal Plaque Index

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  20. Change in Gingival Index

    Time frame: Baseline and immediately after the 16-week intervention

    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.

  21. Change in Bleeding on Probing

    Time frame: Baseline and immediately after the 16-week intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Małgorzata Mizgier, PhD, DSc

CONTACT

[email protected]

+48 61 835 50 00

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Collaborators

  • Ministry of Science and Higher Education, Poland

Registry information

Official study title

A School-Based Anti-Inflammatory Dietary Intervention With or Without a Physical Activity Programme to Support Reproductive Health in Adolescent Girls

Acronym: 4fertil

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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