Apparently Healthy and Not Receiving Hormonal Therapy
Conditions
Keywords
phytoestrogen, flaxseed, SDG lignans, perimenopause, PMS, gene expression
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTSDG lignans
SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Microcrystalline cellulose (Placebo), taken orally once daily for 12 weeks. The capsule is matched in size, color, and taste to the active SDG supplement.
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fold Change From Baseline in FSTL1 Gene Expression | 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 | (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Mean Physical-Symptom Domain Score on the Arabic Premenstrual Syndrome Scale | Time Frame: Baseline (Week 0) and End of Intervention (Week 12) | 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 |
| Change From Baseline in the Mean Psychological-Symptom Domain Score on the Arabic Premenstrual Syndrome Scale | Baseline (Week 0) and end of intervention (Week 12) | 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 |
| Change From Baseline in the Impairment-of-Functioning Domain Score on the Arabic Premenstrual Syndrome Scale | Baseline (Week 0) and end of intervention (Week 12) | 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. |
Countries
Jordan
Outcome results
None listed