Investigating the Impact of Seed Cycling on Menstrual Regularity, Dysmenorrhea, and Premenstrual Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in menstrual cycle from irregular to regular
研究概览
简要总结
The purpose of this research is to investigate the impact of seed cycling on menstrual regularity, cramps, and pre-menstrual symptoms in women with an irregular menstrual cycle and/or dysmenorrhea. The research seeks to provide evidence-based insights into the potential benefits of seed cycling as a holistic approach to women's reproductive health.
It is expected that your participation will last 3 months. Procedures and Activities. You will be provided with and asked to consume specific seeds daily. The seeds are to be consumed as follows: follicular phase (the period from the first day of menstruation (day 1) to ovulation (day 14) in a typical 28-day cycle): 1 tablespoon flax seeds and 1 tablespoon pumpkin seeds, and luteal phase (the period between ovulation and the start of the next period; typically days 15-28): 1 tablespoon sunflower seeds and 1 tablespoon sesame seeds. Before the intervention and once monthly for a total of 3 cycles, you will be asked to complete an online menstrual health symptom questionnaire (MHSQ) and keep track of your menstrual cycle days on the built-in health tracking app on your electronic device.
Risks. Some of the foreseeable risks or discomforts of your participation include the potential for mild gastrointestinal side effects, the potential for allergic reactions, and the possibility of no significant benefit.
Benefits. Possible benefits include the potential for improved menstrual cycle regularity, the potential for a reduction in premenstrual syndrome (PMS) symptoms, and the potential for nutritional benefits. Societal benefits include additional knowledge on seed cycling to help manage menstrual regularity and PMS symptoms.
详细描述
This study will employ a single-arm intervention design. As a single-arm study, all enrolled participants will receive the same seed cycling intervention, and there will be no separate control or comparison group. Data collection will occur over three menstrual cycles for each participant, starting from their individual cycle start dates.
The study duration is approximately three months from September 2025 to December 2025. Data collection will involve a combination of:
• Pre- and Post-Intervention Surveys: Participants will complete a Menstrual Health Symptom Questionnaire (MHSQ)8 via Google Forms. The pre-survey will be administered prior to the intervention, and cycle-end surveys will be conducted at 1-month, 2-month, and 3-month follow-ups after starting the seed cycling intervention.
• Monthly Tracking: Participants will utilize the built-in health tracking app on their electronic device to track their cycle days on the menstrual cycle tracking feature. This tool will facilitate the tracking of period cycle days and will also be used for ongoing tracking of symptoms, supplementing the monthly survey data.
• Individual Email Reminders: To enhance compliance and data completeness, individual email reminders will be sent to participants on a biweekly basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 18-45 with an irregular menstrual cycle and/or menstrual cramps, and/or pre-menstrual symptoms. "Irregular"is defined as a cycle that deviates from the typical pattern of 21 to 35 days between periods
- •Access to an electronic device with a built-in health tracking app that can connect to the internet and is capable of reading QR codes
- •Speak and understandEnglish
排除标准
- •Current or recent use (within the last 3 months) of hormonal birth control or hormone replacement therapy
- •Currently pregnant, lactating, or planning pregnancy between now and December 2025
- •Active gastrointestinal (GI) condition
- •Currently consuming seed oil supplements
- •Allergic to flax seeds, pumpkin seeds, sesame seeds, or sunflower seeds
- •Unable to chew or swallow flax seeds, pumpkin seeds, sesame seeds, or sunflower seeds
- •Daily, regular consumption of flax seeds, pumpkin seeds, sesame seeds, or sunflower seeds
研究组 & 干预措施
Seed Cycling single arm intervention
Subjects will receive sunflower seeds, pumpkin seeds, flaxseed and sesame seeds during the intervention
干预措施: Seed Cycling (Dietary Supplement)
结局指标
主要结局
Change in menstrual cycle from irregular to regular
时间窗: 3 months
The primary endpoint for this study is the proportion of participants reporting a shift to regular menstrual cycles (defined as 21-35 days) after the 3-cycle intervention. This endpoint directly measures the efficacy of the intervention in achieving the primary objective: to determine the proportion of women who self-report a change from irregular to predominantly regular cycles.
次要结局
- Change in menstrual cramp severity(3 months)
- Change in pre-menstrual symptoms(3 months)