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

NCT07310485 | Enrolling By Invitation

• 3 other identifiers: 353/20252025-150/202432152/4/1/3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apparently Healthy and Not Receiving Hormonal Therapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Gene Expression

  Time Frame: Baseline (Week 0) and End of Intervention (Week 12)

Secondary Outcomes (1)

• change of PMS severity scale

  Time Frame: Baseline (Week 0) and End of Intervention (Week 12)

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Intevention SDG lignans

EXPERIMENTAL

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

Dietary Supplement: SDG lignans

Interventions

SDG lignans DIETARY_SUPPLEMENT

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

Also known as: flax seed extract

Intevention SDG lignans

Placebo 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.

placebo

Eligibility Criteria

• Age: 40 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

the university of Jordan

Amman, Amman Governorate, 11942, Jordan

Location

MeSH Terms

Interventions

Linseed Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: November 1, 2025
• Primary Completion: January 2, 2026
• Study Completion: February 20, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)