- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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MELİKGAZİ
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Kayseri, MELİKGAZİ, Turquía (Türkiye)
- Erciyes University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment of Premenstrual Syndrome Scale at the beginning and End of the Study
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Assessment of Dietary Diversity Score at the Beginning and End of the Study
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026/127
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Síndrome Premenstrual-PMS
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Haleema SadiaTerminadoSíndrome Premenstrual-PMSPakistán
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Esra ÖZERKTO Karatay UniversityTerminado
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University of Health Sciences LahoreActivo, no reclutando
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Aydin Adnan Menderes UniversityErzurum Technical UniversityTerminadoRegulación emocional | Síndrome Premenstrual-PMSPavo
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Shaare Zedek Medical CenterDesconocidoSíndrome Premenstrual-PMS
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Activ'insideActivo, no reclutandoSíndrome Premenstrual-PMSItalia
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Izmir Democracy UniversityInscripción por invitaciónSíndrome Premenstrual-PMSPavo
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Universiti Tunku Abdul RahmanTerminado
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Shahjalal University of Science and TechnologyTerminadoIrregularidad menstrual | Dismenorrea | Síndrome Premenstrual-PMSBangladesh
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Endo Health GmbHTerminadoSíndrome premenstrual | Síndrome Premenstrual-PMSAlemania
Ensayos clínicos sobre Seed consumption
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L.V. Prasad Eye InstituteSEED Co. Ltd.Activo, no reclutando
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Chinese University of Hong KongTerminadoDesarrollo, Niño | Atención plenaHong Kong
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Istituto Oncologico Veneto IRCCSAún no reclutandoCáncer de mama | Cirugía conservadora de mamaItalia
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Chinese University of Hong KongXi'an Jiaotong-Liverpool UniversityTerminadoBienestar mental | Desarrollo, Niño | Atención plenaHong Kong
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Brigham and Women's HospitalReclutamientoNeuralgia | Neuropatía | Articulaciones facetarias; DegeneraciónEstados Unidos
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Johnson & Johnson Vision Care, Inc.TerminadoError refractivoHong Kong
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Boin ChoiReclutamientoDesorden del espectro autista | Discapacidades del desarrollo | Retraso en el desarrollo | Formación de profesores | Educación inclusivaCorea del Sur
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University College London HospitalsDesconocidoProgresión del cáncer de próstataReino Unido