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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-19
SponsorPoznan University of Physical Education

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Anti-Inflammatory Diet (AIDiet)Active comparator 1 intervention
Group B: Anti-Inflammatory Diet Plus Physical Activity and Training (AIDiet/PAT)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

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Poznan University of Physical Education

Lead sponsor

Ministry of Science and Higher Education, Poland

Collaborator