NCT07052500

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Nov 2026

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

June 26, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

Seed CyclingMenstrual RegularityDysmenorrheaPremenstrual Symptoms

Outcome Measures

Primary Outcomes (1)

  • Change in menstrual cycle from irregular to regular

    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.

    3 months

Secondary Outcomes (2)

  • Change in menstrual cramp severity

    3 months

  • Change in pre-menstrual symptoms

    3 months

Study Arms (1)

Seed Cycling single arm intervention

EXPERIMENTAL

Subjects will receive sunflower seeds, pumpkin seeds, flaxseed and sesame seeds during the intervention

Dietary Supplement: Seed Cycling

Interventions

Seed CyclingDIETARY_SUPPLEMENT

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

Seed Cycling single arm intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Allied Health Professions

Loma Linda, California, 92354, United States

Location

Related Publications (8)

  • Cassioli E, Rossi E, Melani G, Faldi M, Rellini AH, Wyatt RB, Oester C, Vannuccini S, Petraglia F, Ricca V, Castellini G. The menstrual distress questionnaire (MEDI-Q): reliability and validity of the English version. Gynecol Endocrinol. 2023 Jun 19;39(1):2227275. doi: 10.1080/09513590.2023.2227275.

    PMID: 37356456BACKGROUND
  • Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17.

    PMID: 35320895BACKGROUND
  • Attia GM, Alharbi OA, Aljohani RM. The Impact of Irregular Menstruation on Health: A Review of the Literature. Cureus. 2023 Nov 20;15(11):e49146. doi: 10.7759/cureus.49146. eCollection 2023 Nov.

    PMID: 38130524BACKGROUND
  • Vaziri F, Zamani Lari M, Samsami Dehaghani A, Salehi M, Sadeghpour H, Akbarzadeh M, Zare N. Comparing the effects of dietary flaxseed and omega-3 Fatty acids supplement on cyclical mastalgia in Iranian women: a randomized clinical trial. Int J Family Med. 2014;2014:174532. doi: 10.1155/2014/174532. Epub 2014 Aug 13.

    PMID: 25197571BACKGROUND
  • Matar SS, Farrag AA, Hafez SM, Fahmy RM. The Bioactive Effect of Flaxseed on Women with the Polycystic Ovarian Syndrome. Egyptian Journal of Nutrition. 2021;36(3):49-77. doi: 10.21608/enj.2021.209919

    BACKGROUND
  • Haidari F, Banaei-Jahromi N, Zakerkish M, Ahmadi K. The effects of flaxseed supplementation on metabolic status in women with polycystic ovary syndrome: a randomized open-labeled controlled clinical trial. Nutr J. 2020 Jan 24;19(1):8. doi: 10.1186/s12937-020-0524-5.

    PMID: 31980022BACKGROUND
  • Phipps WR, Martini MC, Lampe JW, Slavin JL, Kurzer MS. Effect of flax seed ingestion on the menstrual cycle. J Clin Endocrinol Metab. 1993 Nov;77(5):1215-9. doi: 10.1210/jcem.77.5.8077314.

    PMID: 8077314BACKGROUND
  • Rasheed N, Ahmed A, Nosheen F, Imran A, Islam F, Noreen R, Chauhan A, Shah MA, Amer Ali Y. Effectiveness of combined seeds (pumpkin, sunflower, sesame, flaxseed): As adjacent therapy to treat polycystic ovary syndrome in females. Food Sci Nutr. 2023 Mar 25;11(6):3385-3393. doi: 10.1002/fsn3.3328. eCollection 2023 Jun.

    PMID: 37324929BACKGROUND

MeSH Terms

Conditions

Menstruation DisturbancesDysmenorrhea

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Lesley Ann Foster- Nicholas, DrPH, MPH, RDN

CONTACT

Victoria LLerena, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to concerns about participant privacy, potential for re-identification, and the risk of data misuse.

Locations