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Examining the Impact of Phytoestrogens Supplementation on the Gene Expression, and Premenstrual Syndrome in Primenopausal Women

NCT ID: NCT07310485

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-02-20

Brief Summary

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This randomized, double-blind, placebo-controlled clinical trial aims to investigate the effect of flaxseed-derived phytoestrogen supplementation on gene expression of Anti-Müllerian Hormone (AMH) and its receptor (AMHR2), as well as the experience and severity of premenstrual syndrome (PMS), among perimenopausal women aged 40-55 years in Jordan. Participants will receive either flaxseed phytoestrogen extract (secoisolariciresinol diglucoside, SDG) or placebo for 12 weeks. Changes in gene expression and PMS severity will be assessed at baseline and post-intervention to explore the potential role of phytoestrogens in modulating ovarian aging and menstrual-related symptoms.

Detailed Description

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Menopause is a natural biological transition characterized by progressive ovarian aging, hormonal fluctuations, and changes in menstrual patterns. Anti-Müllerian Hormone (AMH) and its receptor (AMHR2) play central roles in ovarian folliculogenesis and are considered reliable biomarkers of ovarian reserve and reproductive aging. Reduced AMH levels have been associated with earlier onset of menopause.

Phytoestrogens are plant-derived compounds structurally similar to endogenous estrogens and are capable of interacting with estrogen receptors, exerting weak estrogenic or anti-estrogenic effects depending on the hormonal milieu. Flaxseed is one of the richest dietary sources of lignans, particularly secoisolariciresinol diglucoside (SDG), which is metabolized into bioactive enterolignans.

This study is designed as a randomized, double-blind, placebo-controlled trial to evaluate the effect of daily SDG supplementation on AMH and AMHR2 gene expression and on the experience and severity of premenstrual syndrome in perimenopausal women aged 40-55 years. Participants will be randomly assigned to receive either SDG capsules (100 mg/day) or placebo for 12 weeks. Gene expression will be assessed using salivary samples collected at baseline and post-intervention. PMS severity will be evaluated using a validated Premenstrual Syndrome Scale.

Findings from this trial may contribute to understanding the role of dietary phytoestrogens in modulating reproductive aging and menstrual-related symptoms and may support future development of personalized nutritional strategies for women approaching menopause.

Conditions

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Apparently Healthy and Not Receiving Hormonal Therapy

Keywords

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phytoestrogen, flaxseed, SDG lignans, perimenopause, PMS, gene expression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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placebo

Microcrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active phytoestrogen supplement.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Microcrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active SDG supplement.

Intevention SDG lignans

Dietary Supplement: SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks

Group Type EXPERIMENTAL

SDG lignans

Intervention Type DIETARY_SUPPLEMENT

SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks

Interventions

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SDG lignans

SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Microcrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active SDG supplement.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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flax seed extract

Eligibility Criteria

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Inclusion Criteria

Women aged 40-55 years Jordanian nationality Body mass index (BMI) between 19 and 29.9 kg/m² Apparently healthy and not receiving hormonal therapy -

Exclusion Criteria

Pregnancy or lactation Use of hormonal replacement therapy or hormonal contraceptives Diagnosis of chronic metabolic, cardiovascular, liver, kidney, autoimmune, or malignant disease History of gynecological disorders or surgeries Use of dietary supplements or special diets within the previous 3 months Habitual consumption of flaxseed or phytoestrogen supplements Active bowel disease or malabsorption syndrome

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Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Hadeel Ali Ghazzawi

prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the university of Jordan

Amman, Amman Governorate, Jordan

Site Status

Countries

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Jordan

Other Identifiers

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2025-150/2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

32152/4/1/3

Identifier Type: OTHER

Identifier Source: secondary_id

353/2025

Identifier Type: -

Identifier Source: org_study_id