Reproductive Health4fertilNCT07834489
Anti-Inflammatory Diet and Physical Activity for Reproductive Health in Adolescent Girls
A study testing Anti-Inflammatory Dietary Intervention and Physical Activity and Training Programme in people with Reproductive Health, run by Poznan University of Physical Education at 2 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health
- What is being tested?
- Anti-Inflammatory Dietary Intervention and Physical Activity and Training Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPoland
- Study dates
- 20 Oct 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Liceum Ogólnokształcące Św. Marii Magdaleny
Poznan, Greater Poland Voivodeship, 61-867
Małgorzata Mizgier, mizgier@awf.poznan.pl
- Recruiting
Liceum Ogólnokształące im. Powstanców Wielkopolskich
Środa Wielkopolska, Greater Poland Voivodeship, 63-000
Małgorzata Mizgier, mizgier@awf.poznan.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- Reproductive Health
- Being tested
- Anti-Inflammatory Dietary Intervention, Physical Activity and Training Programme
- Keywords
- Anti-Inflammatory Diet, Mediterranean Diet, Physical Activity, Diet Quality, Menstrual Health, Premenstrual Symptoms, Menstrual Pain, KIDMED, Salivary Biomarkers, Oral Microbiome
- Medical subject headings
- Motor Activity, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Inflammatory Dietary InterventionBehavioural
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 ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Anti-Inflammatory Dietary Intervention |
| Anti-Inflammatory Diet Plus Physical Activity and Training (AIDiet/PAT) | 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. Receives: Behavioral: Anti-Inflammatory Dietary Intervention; Behavioral: Physical Activity and Training Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the 16-week intervention
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after the 16-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Higher Education, Poland
- Responsible party
- Sponsor
- Investigators
- Małgorzata Mizgier, Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834489
- Sponsor's protocol ID
- 4FERTIL-ADO-01
- Other IDs
- NdRS/SP/0124/2025/01
- Acronym
- 4fertil
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No