School of Allied Health Professions
Loma Linda, California, 92354, United States
NCT Number: NCT07052500
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Loma Linda, California, 92354, United States
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:
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:
•
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.
▪
Timeframes:
•
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).
▪
Timeframes:
▪ 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:
▪
Timeframes:
▪ 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily consumption of 1 tablespoon each of flax and pumpkin seeds during the follicular phase and 1 tablespoon each of sunflower and sesame seeds during the luteal phase
Time frame: 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.
Time frame: 3 months
Change in menstrual cramp severity will be assessed using a validated pain scale administered during menstruation, comparing severity during the intervention cycles to the participants' self-reported historical experience. This Page 4 of 16 endpoint will evaluate the intervention's impact on a key symptom associated with menstrual cycles.
Time frame: 3 months
Change in pre-menstrual symptoms including 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. Participants will report on the presence and severity of these symptoms using a standardized questionnaire. This endpoint will assess the broader influence of the intervention on overall well-being before and during the menstrual cycle.
Loma Linda University
Other
Investigating the Impact of Seed Cycling on Menstrual Regularity, Dysmenorrhea, and Premenstrual Symptoms
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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