- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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MELİKGAZİ
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Kayseri, MELİKGAZİ, Turquia (Türkiye)
- Erciyes University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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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Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Assessment of Premenstrual Syndrome Scale at the beginning and End of the Study
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Assessment of Dietary Diversity Score at the Beginning and End of the Study
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: ARMAĞAN AYTUĞ YÜRÜK, Principal Investigator, TC Erciyes University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026/127
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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