Anti-Inflammatory Diet and Physical Activity for Reproductive Health in Adolescent Girls (4fertil)

A School-Based Anti-Inflammatory Dietary Intervention With or Without a Physical Activity Programme to Support 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.

Study Overview

• Status: Recruiting
• Conditions: Reproductive Health
• Intervention / Treatment: Behavioral: Anti-Inflammatory Dietary Intervention; Behavioral: Physical Activity and Training Programme

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Małgorzata Mizgier, PhD, DSc; Phone Number: +48 61 835 50 00; Email: mizgier@awf.poznan.pl

Study Locations

• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-867
      • Recruiting
      • Liceum Ogólnokształcące Św. Marii Magdaleny
      • Contact: Małgorzata Mizgier; Email: mizgier@awf.poznan.pl
    • Środa Wielkopolska, Greater Poland Voivodeship, Poland, 63-000
      • Recruiting
      • Liceum Ogólnokształące im. Powstanców Wielkopolskich
      • Contact: Małgorzata Mizgier; Email: mizgier@awf.poznan.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anti-Inflammatory Diet (AIDiet); 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; 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.
Experimental: Anti-Inflammatory Diet Plus Physical Activity and Training (AIDiet/PAT); 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; 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and immediately after the 16-week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and immediately after the 16-week intervention

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education
• Collaborators: Ministry of Science and Higher Education, Poland
• Investigators: Principal Investigator: Małgorzata Mizgier, Poznan University of Physical Education

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Mediterranean Diet; Menstrual Pain; Anti-Inflammatory Diet; Diet Quality; Oral Microbiome; Menstrual Health; Premenstrual Symptoms; Salivary Biomarkers; KIDMED
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Dysmenorrhea; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 4FERTIL-ADO-01; NdRS/SP/0124/2025/01 (Other Grant/Funding Number: Ministry of Science and Higher Education)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No