Apparently Healthy and Not Receiving Hormonal TherapyNCT07310485
Examining the Impact of Phytoestrogens Supplementation on the Gene Expression, and Premenstrual Syndrome in Primenopausal Women
A study testing SDG lignans in people with Apparently Healthy and Not Receiving Hormonal Therapy, run by University of Jordan at 1 site in Jordan.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial investigated the effects of flaxseed-derived phytoestrogen supplementation on selected gene-expression markers and premenstrual syndrome (PMS) severity among perimenopausal women aged 40-55 years in Jordan. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Apparently Healthy and Not Receiving Hormonal Therapy
- What is being tested?
- SDG lignans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2026to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Jordanian women aged 40-55 years
- Regular menstrual cycles during the 90 days preceding enrollment
- Body mass index between 19.0 and 29.9 kg/m²
- Apparently healthy
Who cannot join
- Pregnancy or lactation
- Current use of hormone replacement therapy or hormonal contraceptives
- Diagnosis of a chronic metabolic, cardiovascular, hepatic, renal, autoimmune, or malignant disease
- History of gynecological disorders or gynecological surgery
- Use of dietary supplements or adherence to a special diet during the 90 days preceding enrollment
- Habitual consumption of flaxseed or use of phytoestrogen supplements
- Active bowel disease or malabsorption syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Impact of Phytoestrogens Supplementation on the Gene Expression and Premenstrual Syndrome in Perimenopausal Women Aged 40-55 in Jordan
This randomized, double-blind, placebo-controlled clinical trial investigated the effects of flaxseed-derived phytoestrogen supplementation on selected gene-expression markers and premenstrual syndrome (PMS) severity among perimenopausal women aged 40-55 years in Jordan. Participants received either a flaxseed lignan extract providing 100 mg of lignans daily or a matched placebo for 12 weeks. Gene expression and PMS severity were assessed at baseline and at the end of the intervention to examine the potential effects of phytoestrogen supplementation on selected molecular markers and menstrual-related symptoms.
Read the detailed description
The menopausal transition is a natural biological process characterized by progressive changes in ovarian function, hormonal fluctuations, and alterations in menstrual patterns. During this transition, premenstrual symptoms may persist or change in severity, potentially affecting women's physical and psychological well-being and daily functioning.
Phytoestrogens are plant-derived compounds that share structural similarities with endogenous estrogens and may interact with estrogen receptors, exerting weak estrogenic or anti-estrogenic effects depending on the hormonal environment. Flaxseed is a rich dietary source of lignans, including secoisolariciresinol diglucoside, which can be metabolized by intestinal bacteria into bioactive enterolignans.
This randomized, double-blind, placebo-controlled trial evaluated the effects of daily flaxseed-derived phytoestrogen supplementation on selected gene-expression markers and premenstrual syndrome severity among perimenopausal women aged 40-55 years in Jordan. Participants received either a flaxseed lignan extract providing 100 mg of lignans daily or a matched microcrystalline-cellulose placebo for 12 weeks. The expression of FSTL1 and TGFB1 was assessed using buccal-cell samples collected at baseline and at the end of the intervention. Premenstrual symptoms were evaluated using the validated Arabic Premenstrual Syndrome Scale.
The findings may contribute to understanding the potential effects of flaxseed-derived phytoestrogens on selected molecular markers and premenstrual symptoms among women undergoing the menopausal transition and may inform future nutrition research in this population.
- Being tested
- SDG lignans, Placebo
- Keywords
- phytoestrogen, flaxseed, SDG lignans, perimenopause, PMS, gene expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDG lignansDietary supplement
Also called flax seed extract
SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Placebo |
| Intevention SDG lignans | Experimental | Dietary Supplement: SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks Receives: Dietary Supplement: SDG lignans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold Change From Baseline in FSTL1 Gene Expression
Outcome Measure Description: FSTL1 gene expression is quantified in buccal-cell samples using quantitative real-time polymerase chain reaction and normalized to GAPDH expression. The fold change from baseline to Week 12 is calculated using the 2^-ΔΔCt method. A fold-change value of 1 indicates no change, a value greater than 1 indicates increased expression, and a value less than 1 indicates decreased expression.
Measured: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)
Fold Change From Baseline in TGFB1 Gene Expression
Outcome Measure Description: TGFB1 gene expression is quantified in buccal-cell samples using quantitative real-time polymerase chain reaction and normalized to GAPDH expression. The fold change from baseline to Week 12 is calculated using the 2^-ΔΔCt method. A fold-change value of 1 indicates no change, a value greater than 1 indicates increased expression, and a value less than 1 indicates decreased expression.
Measured: (Week 0) and end of intervention (Week 12)
Secondary outcomes (3)
Change From Baseline in the Mean Physical-Symptom Domain Score on the Arabic Premenstrual Syndrome Scale
The Arabic Premenstrual Syndrome Scale includes 23 items rated from 0 (no symptoms) to 3 (severe symptoms). The physical-symptom domain comprises 10 items, and its score is calculated as the mean of the item responses. The domain score ranges from 0 to 3, with higher scores indicating worse physical symptoms. Change from baseline is calculated as the Week 12 score minus the baseline score and can range from -3 to +3. Negative change values indicate
Measured: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)
Change From Baseline in the Mean Psychological-Symptom Domain Score on the Arabic Premenstrual Syndrome Scale
Outcome Measure Description: The Arabic Premenstrual Syndrome Scale includes 23 items rated from 0 (no symptoms) to 3 (severe symptoms). The psychological-symptom domain comprises 12 items, and its score is calculated as the mean of the item responses. The domain score ranges from 0 to 3, with higher scores indicating worse psychological symptoms. Change from baseline is calculated as the Week 12 score minus the baseline score and can range from -3 to +3. Negative change values indicate improvement
Measured: Baseline (Week 0) and end of intervention (Week 12)
Change From Baseline in the Impairment-of-Functioning Domain Score on the Arabic Premenstrual Syndrome Scale
Outcome Measure Description: The impairment-of-functioning domain of the Arabic Premenstrual Syndrome Scale evaluates the extent to which premenstrual symptoms interfere with functioning. The domain score ranges from 0 to 3, with higher scores indicating greater functional impairment and therefore a worse outcome. Change from baseline is calculated as the Week 12 score minus the baseline score and can range from -3 to +3. Negative change values indicate improvement.
Measured: Baseline (Week 0) and end of intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2026
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apparently Healthy and Not Receiving Hormonal TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Ali Ghazzawi, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310485
- Sponsor's protocol ID
- 353/2025
- Other IDs
- 2025-150/2024, 32152/4/1/3
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Phytoestrogens Supplementation on the Gene Expression and Premenstrual Syndrome in Perimenopausal Women Aged 40-55 in Jordan
- ClinicalTrials.gov ID
- NCT07310485
- Acronym / sponsor ID
- 353/2025
- Keywords
- phytoestrogen, flaxseed, SDG lignans, perimenopause, PMS, gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled clinical trial investigated the effects of flaxseed-derived phytoestrogen supplementation on selected gene-expression markers and premenstrual syndrome (PMS) severity among perimenopausal women aged 40-55 years in Jordan. Participants received either a flaxseed lignan extract providing 100 mg of lignans daily or a matched placebo for 12 weeks. Gene expression and PMS severity were assessed at baseline and at the end of the intervention to examine the potential effects of phytoestrogen supplementation on selected molecular markers and menstrual-related symptoms.
Detailed description
The menopausal transition is a natural biological process characterized by progressive changes in ovarian function, hormonal fluctuations, and alterations in menstrual patterns. During this transition, premenstrual symptoms may persist or change in severity, potentially affecting women's physical and psychological well-being and daily functioning.
Phytoestrogens are plant-derived compounds that share structural similarities with endogenous estrogens and may interact with estrogen receptors, exerting weak estrogenic or anti-estrogenic effects depending on the hormonal environment. Flaxseed is a rich dietary source of lignans, including secoisolariciresinol diglucoside, which can be metabolized by intestinal bacteria into bioactive enterolignans.
This randomized, double-blind, placebo-controlled trial evaluated the effects of daily flaxseed-derived phytoestrogen supplementation on selected gene-expression markers and premenstrual syndrome severity among perimenopausal women aged 40-55 years in Jordan. Participants received either a flaxseed lignan extract providing 100 mg of lignans daily or a matched microcrystalline-cellulose placebo for 12 weeks. The expression of FSTL1 and TGFB1 was assessed using buccal-cell samples collected at baseline and at the end of the intervention. Premenstrual symptoms were evaluated using the validated Arabic Premenstrual Syndrome Scale.
The findings may contribute to understanding the potential effects of flaxseed-derived phytoestrogens on selected molecular markers and premenstrual symptoms among women undergoing the menopausal transition and may inform future nutrition research in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: PlaceboMicrocrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active phytoestrogen supplement. |
| Intevention SDG lignans | Experimental | Dietary Supplement: SDG lignansDietary Supplement: SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Jordanian women aged 40-55 years
- Regular menstrual cycles during the 90 days preceding enrollment
- Body mass index between 19.0 and 29.9 kg/m²
- Apparently healthy
Key exclusion criteria (7 listed)
- Pregnancy or lactation
- Current use of hormone replacement therapy or hormonal contraceptives
- Diagnosis of a chronic metabolic, cardiovascular, hepatic, renal, autoimmune, or malignant disease
- History of gynecological disorders or gynecological surgery
- Use of dietary supplements or adherence to a special diet during the 90 days preceding enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDG lignansAlso: flax seed extractSDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks | Dietary supplement | Intevention SDG lignans |
| PlaceboMicrocrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active SDG supplement. | Dietary supplement | placebo |
Primary outcome
Fold Change From Baseline in FSTL1 Gene Expression
Time frame: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)
Outcome Measure Description: FSTL1 gene expression is quantified in buccal-cell samples using quantitative real-time polymerase chain reaction and normalized to GAPDH expression. The fold change from baseline to Week 12 is calculated using the 2^-ΔΔCt method. A fold-change value of 1 indicates no change, a value greater than 1 indicates increased expression, and a value less than 1 indicates decreased expression.
Fold Change From Baseline in TGFB1 Gene Expression
Time frame: (Week 0) and end of intervention (Week 12)
Outcome Measure Description: TGFB1 gene expression is quantified in buccal-cell samples using quantitative real-time polymerase chain reaction and normalized to GAPDH expression. The fold change from baseline to Week 12 is calculated using the 2^-ΔΔCt method. A fold-change value of 1 indicates no change, a value greater than 1 indicates increased expression, and a value less than 1 indicates decreased expression.
3 secondary outcomes
Change From Baseline in the Mean Physical-Symptom Domain Score on the Arabic Premenstrual Syndrome Scale
Time frame: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)
Change From Baseline in the Mean Psychological-Symptom Domain Score on the Arabic Premenstrual Syndrome Scale
Time frame: Baseline (Week 0) and end of intervention (Week 12)
Change From Baseline in the Impairment-of-Functioning Domain Score on the Arabic Premenstrual Syndrome Scale
Time frame: Baseline (Week 0) and end of intervention (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDG lignans in people with Apparently Healthy and Not Receiving Hormonal Therapy, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fold Change From Baseline in FSTL1 Gene Expression (time frame: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.