- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07575698
The Effect of Seed Cycling-Based Nutritional Intervention on Premenstrual Symptoms
Evaluation of the Effect of Seed Cycling on Premenstrual Symptoms in Healthy Adults
This study aims to investigate the effects of the seed-cycling intervention on premenstrual symptoms and nutritional status. At the beginning of the study, written informed consent will be obtained from all individuals who agree to participate.
During the month prior to the intervention, participants' menstrual cycles will be monitored to determine their menstrual phases. In this period, dietary intake records and menstrual symptoms will be documented, and the estimated ovulation date will be determined based on reported symptoms.
After identifying the participants' follicular phase (approximately days 1-14) and luteal phase (approximately days 15-28), the intervention will be implemented for three consecutive months. Participants will be instructed to consume flaxseed and pumpkin seeds daily during the follicular phase, and sesame seeds and sunflower seeds daily during the luteal phase.
The oilseeds to be consumed will be provided to the participants at the beginning of each month in vacuum-sealed single-use packages.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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MELİKGAZİ
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Kayseri, MELİKGAZİ, Turchia (Türkiye)
- Erciyes University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria: Individuals aged 18-35 years, with a regular menstrual cycle, a body mass index (BMI) between 18.5 and 24.9 kg/m², who agreed to consume oilseeds for three menstrual cycles, and who are literate with no problems in Turkish communication or comprehension were included in the study.
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Exclusion Criteria: Individuals were excluded if they were pregnant, lactating, or postmenopausal; had acute, chronic, or psychiatric disorders including hormonally diagnosed conditions such as PCOS that could affect menstruation; were receiving medications affecting hormones or menstrual cycles; were taking vitamin, mineral, or nutraceutical supplements; had allergies or intolerances to flaxseed, sunflower seeds, pumpkin seeds, or sesame; were positive for HIV or HPV infection; consumed alcohol regularly; or were following a special diet.
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Assessment of Premenstrual Syndrome Scale at the beginning and End of the Study
Lasso di tempo: The premenstrual weeks of the first and fourth months of the study
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To evaluate the severity of symptoms experienced during the premenstrual period, the Premenstrual Syndrome Scale, a validated instrument, will be administered during the premenstrual weeks of the first and fourth months. The Premenstrual Syndrome Scale is a self-report measure developed to assess the physical, emotional, and behavioral symptoms experienced by women during the luteal phase of the menstrual cycle. The scale consists of a total of 44 items and comprises nine subdimensions. Each item is rated on a five-point Likert scale. Higher total scores obtained from the scale indicate greater severity of premenstrual symptoms. Subdimension scores may be calculated separately, and an overall assessment can also be conducted based on the total score. |
The premenstrual weeks of the first and fourth months of the study
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Assessment of Dietary Diversity Score at the Beginning and End of the Study
Lasso di tempo: At the beginning of the first month and at the end of the fourth month of the study
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The Dietary Diversity Score is based on the nine food groups recommended by the Food and Agriculture Organization.
According to the scoring system, a score of ≥6 points is classified as high dietary diversity, 4-5 points as moderate dietary diversity, and ≤3 points as low dietary diversity.
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At the beginning of the first month and at the end of the fourth month of the study
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Assessment of Composite Dietary Antioxidant Index at the Beginning and End of the Study
Lasso di tempo: At the beginning of the first month and at the end of the fourth month of the study
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The Composite Dietary Antioxidant Index (CDAI) is a quantitative measure that reflects the overall impact of the major antioxidant nutrients consumed through the diet and is used to assess the total antioxidant capacity of the diet.
This index is considered a reliable indicator as it represents the cumulative effect of dietary antioxidants.The Composite Dietary Antioxidant Index will be calculated based on individuals' 24-hour dietary intake records, by assessing the intake of six antioxidant nutrients: vitamin A, vitamin C, vitamin E, carotenoids, zinc, and selenium.
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At the beginning of the first month and at the end of the fourth month of the study
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: ARMAĞAN AYTUĞ YÜRÜK, Principal Investigator, TC Erciyes University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026/127
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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