NCT07575698

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Mar 2027

Study Start

First participant enrolled

March 20, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Expected
Last Updated

May 8, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

seed consumptionpremenstrual syndromefollicular phaseluteal phase

Outcome Measures

Primary Outcomes (1)

  • Assessment of Premenstrual Syndrome Scale at the beginning and End 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

Secondary Outcomes (2)

  • Assessment of Dietary Diversity Score at the Beginning and End of the Study

    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

    At the beginning of the first month and at the end of the fourth month of the study

Interventions

Seed consumptionDIETARY_SUPPLEMENT

After identifying the participants' follicular phase (approximately days 1-14) and luteal phase (approximately days 15-28), they will consume specific seeds daily for three consecutive months. During the follicular phase, participants will consume flaxseed and pumpkin seeds per day. During the luteal phase, they will consume sesame seeds and sunflower seeds per day. The oilseeds to be consumed will be provided to the participants at the beginning of each month in vacuum-sealed, single-use packages. Participants with a compliance rate of less than 80% will be excluded from the study.

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy female volunteers between the ages of 18 and 35 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, MELİKGAZİ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • ARMAĞAN AYTUĞ YÜRÜK, Principal Investigator

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

March 20, 2026

Primary Completion

March 20, 2026

Study Completion (Estimated)

March 20, 2027

Last Updated

May 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations