Examining the Impact of Phytoestrogens Supplementation on the Gene Expression and Premenstrual Syndrome in Perimenopausal Women Aged 40-55 in Jordan
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fold Change From Baseline in FSTL1 Gene Expression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intevention SDG lignans
Dietary Supplement: SDG lignans phytoestrogen 100 mg SDG (Active Ingredient), taken orally once daily for 12 weeks
干预措施: SDG lignans (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 phytoestrogen supplement.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Fold Change From Baseline in FSTL1 Gene Expression
时间窗: 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
时间窗: (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.
Change in Gene Expression
时间窗: Time Frame: Baseline (Week 0) and End of Intervention (Week 12)
次要结局
- 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))
- 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))
- 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))
- change of PMS severity scale(Time Frame: Baseline (Week 0) and End of Intervention (Week 12))
研究者
Hadeel Ali Ghazzawi
prof
University of Jordan