Examining the Impact of Phytoestrogens Supplementation on the Gene Expression, and Premenstrual Syndrome in Primenopausal Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SDG lignans, Placebo.
- Who it may be relevant to
- Registry conditions: Apparently Healthy and Not Receiving Hormonal Therapy. Basic parameters: 40 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Examining the Impact of Phytoestrogens Supplementation and on the Gene Expression of Anti-Müllerian Hormone, Its Receptor, and Premenstrual Syndrome in Primenopausal Women Aged 40-55 in Jordan
Overview
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
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.
Interventions
- Dietary supplement SDG lignans
SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks - 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.
Primary outcome measures
- Change in Gene Expression [Time frame: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)]
Secondary outcome measures (1)
- change of PMS severity scale [Time frame: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Jordan · 1 center
- the university of Jordan — Amman
Identifiers
NCT: NCT07310485 · 353/2025 · 2025-150/2024 · 32152/4/1/3