Impact of Seed Cycling on Menstrual Regularity, Dysmenorrhea, and Premenstrual Symptoms

Description

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.

e. Study Procedures and Schedule This study involves a series of structured visits and ongoing self-monitoring to assess the impact of the seed cycling intervention on menstrual cycle regularity and associated symptoms. All procedures related to the seed cycling intervention and associated data collection are considered experimental and specifically designed for the purpose of this research study. There are no elements of “routine care” integrated into this study, as the intervention itself is not a standard medical practice.

Measures and Timeframes

The following specific tests and measures will be carried out:

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Menstrual Health Symptom Questionnaire (MHSQ):

This is a validated, self-administered questionnaire administered online via Google Forms. It collects detailed information on participants’ menstrual cycle regularity, duration, associated symptoms (e.g., lower abdomen pain, breast tenderness, muscle pain, nausea, bone pain, feeling bloated, diarrhea, joint pain, headaches, constipation, feeling excessively sad, feeling emotionally unstable, feeling irritable or short-tempered, feeling anxious, being excessively hungry or feeling lack of hunger, having insomnia, and feeling excessively tired) and their severity.

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Timeframes:

• Baseline/Pre-intervention: Completed at Visit 1 (Day 1). This MHSQ will serve as the baseline measure for all menstrual health symptoms and cycle characteristics.

• Post-intervention/Follow-up: Completed at Visit 2 (Day 28), Visit 3 (Day 56), and at the End of Study (Day 84 or last day of the third cycle).

• Acceptable Window: Completion of the MHSQ is expected on the scheduled day of each visit. A window of ± 2 days from the scheduled day for online completion is considered acceptable to account for unforeseen participant availability, but efforts will be made to ensure timely completion.

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Menstrual Cycle Tracking via smartphone health tracking app:

▪ Menstrual Cycle Days: Start and end dates of menstruation.

▪ Symptom Tracking: Daily or periodic recording of menstrual symptoms as outlined in the MHSQ (serving as a supplementary, continuous record to the periodic MHSQ completions).

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Timeframes:

• Orientation and study overview for participants will occur on Visit 1 (Day 1) in the Nichol Hall Kitchen. Participants will be instructed to begin tracking immediately after training.

• Throughout the Study: Participants will continuously track their cycles and symptoms from Day 1 until the end of study (Day 84 or last day of the third cycle).

• Verification: At Visit 2 (Day 28) in the Nichol Hall Kitchen, accuracy of use of the menstrual cycle tracking feature on the participants’ smartphone health tracking apps will be verified. This will allow for real-time feedback and correction if tracking issues are identified.

▪ Acceptable Window: Daily tracking is expected. Minor gaps of 1-2 days in tracking may be acceptable if clear recall allows for accurate back-entry, but consistent daily logging will be encouraged.

Experimental Procedures

All components of the intervention and data collection are experimental procedures for the purpose of this study:

Provision of Seed Cycling Intervention Materials:

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Timeframes:

• Visit 1 (Day 1): Provision of 1 month (28 days) of individually packaged and labeled seeds with the corresponding seed cycling schedule.

• Visit 2 (Day 28): Provision of the second month’s supply of seeds (28 days) and schedule. If the menstrual cycle has not started by day 28, additional sunflower and sesame seeds will be provided for use until the next cycle commences.

• Visit 3 (Day 56): Provision of the third month’s supply of seeds (28 days) and schedule. If the menstrual cycle has not started by day 56, additional sunflower and sesame seeds will be provided for use until the next cycle commences.

▪ This involves the distribution of specific, pre-portioned seeds (flax, pumpkin, sesame, and sunflower) according to the predefined seed cycling schedule. The packaging and labeling will ensure adherence to the correct sequence and dosage.