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NCT Number: NCT07575698

The Effect of Seed Cycling-Based Nutritional Intervention on Premenstrual Symptoms

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Seed Cycling Menstruation Disturbances Nutrition Habits Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome Premenstrual Syndrome-PMS

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Erciyes University

Kayseri, MELİKGAZİ, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals aged 18-35 years, with a regular menstrual cycle, a body mass index (BMI) between 18.5 and 24.9 kg/m², who agreed to consume oilseeds for three menstrual cycles, and who are literate with no problems in Turkish communication or comprehension were included in the study.

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Exclusion criteria

Individuals were excluded if they were pregnant, lactating, or postmenopausal; had acute, chronic, or psychiatric disorders including hormonally diagnosed conditions such as PCOS that could affect menstruation; were receiving medications affecting hormones or menstrual cycles; were taking vitamin, mineral, or nutraceutical supplements; had allergies or intolerances to flaxseed, sunflower seeds, pumpkin seeds, or sesame; were positive for HIV or HPV infection; consumed alcohol regularly; or were following a special diet.

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Treatment and study plan

Seed consumption

Dietary 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.

Primary outcomes

  1. Assessment of Premenstrual Syndrome Scale at the beginning and End of the Study

    Time frame: The premenstrual weeks of the first and fourth months 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.

Secondary outcomes

  1. Assessment of Dietary Diversity Score at the Beginning and End of the Study

    Time frame: At the beginning of the first month and at the end of the fourth month of the study

    The Dietary Diversity Score is based on the nine food groups recommended by the Food and Agriculture Organization. According to the scoring system, a score of ≥6 points is classified as high dietary diversity, 4-5 points as moderate dietary diversity, and ≤3 points as low dietary diversity.

  2. Assessment of Composite Dietary Antioxidant Index at the Beginning and End of the Study

    Time frame: At the beginning of the first month and at the end of the fourth month of the study

    The Composite Dietary Antioxidant Index (CDAI) is a quantitative measure that reflects the overall impact of the major antioxidant nutrients consumed through the diet and is used to assess the total antioxidant capacity of the diet. This index is considered a reliable indicator as it represents the cumulative effect of dietary antioxidants.The Composite Dietary Antioxidant Index will be calculated based on individuals' 24-hour dietary intake records, by assessing the intake of six antioxidant nutrients: vitamin A, vitamin C, vitamin E, carotenoids, zinc, and selenium.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Evaluation of the Effect of Seed Cycling on Premenstrual Symptoms in Healthy Adults

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

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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