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The Effect of Seed Cycling-Based Nutritional Intervention on Premenstrual Symptoms

2026年5月4日 更新者:Armağan Aytuğ Yürük、TC Erciyes University

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.

研究概览

研究类型

观察性的

注册 (估计的)

48

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Healthy female volunteers between the ages of 18 and 35 years

描述

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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学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assessment of Premenstrual Syndrome Scale at the beginning and End of the Study
大体时间:The premenstrual weeks of the first and fourth months of the study

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

次要结果测量

结果测量
措施说明
大体时间
Assessment of Dietary Diversity Score at the Beginning and End of the Study
大体时间:At the beginning of the first month and at the end of the fourth month of the study
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.
At the beginning of the first month and at the end of the fourth month of the study
Assessment of Composite Dietary Antioxidant Index at the Beginning and End of the Study
大体时间:At the beginning of the first month and at the end of the fourth month of the study
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.
At the beginning of the first month and at the end of the fourth month of the study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:ARMAĞAN AYTUĞ YÜRÜK, Principal Investigator、TC Erciyes University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月20日

初级完成 (实际的)

2026年3月20日

研究完成 (估计的)

2027年3月20日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

Individual participant data will not be shared due to participant privacy and confidentiality concerns

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研究美国 FDA 监管的设备产品

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