Effects of 12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Numeric working memory task % accuracy
研究概览
简要总结
Perimenopause is a transition phase into menopause, characterised by menopausal symptoms while menstrual periods are still occurring. Common symptoms of perimenopause include hot flushes, night sweats, mood swings, anxiety, sleep disturbances, fatigue, and cognitive difficulties. These symptoms can be both frequent and intense, with the potential to significantly deteriorate women's quality of life. Despite an increase in public discourse around menopause, there are still large gaps in knowledge. Previous literature has suggested a relationship between diet and menopause management. However, studies in this area are limited and women often rely on social media for advice on supplements to address menopause complaints. One supplement that has received a lot of attention with purported benefits for menopause is magnesium, primarily due to its links to energy and or/sleep, however no studies have explored psychological effects of magnesium supplementation in perimenopause.
The aim of this study is to explore the effects of 12-weeks magnesium supplementation on perimenopause symptoms, cognition, sleep, and psychological well-being.
详细描述
The term "perimenopause" describes a woman's life stage during which she undergoes changes due to hormone fluctuations but has not yet gone a full year without menstruation. It is a normal aspect of aging that typically affects women between the ages of 45 and 55, although some women may experience it sooner. While each person experiences symptoms differently, some common symptoms include irregular periods, hot flushes, night sweats, mood fluctuations, difficulty sleeping, decreased libido, vaginal dryness, memory and concentration problems. One widely recognised treatment for managing menopause symptoms is hormone replacement therapy (HRT). Although the benefits of HRT generally outweigh the risks, alternative options are needed for those with a history of breast cancer. Concerns surrounding risks have led many women to explore alternative approaches, including botanical and dietary supplements despite limited research on their efficacy and long-term effects. Women are increasingly turning to social media for advice on how to manage symptoms, and supplement manufacturers are beginning to target this audience with claims that they can reduce menopause symptoms. There is evidence of a link between nutrition and menopause, however research in this area is limited, especially in perimenopause. Magnesium is commonly promoted as a treatment for menopause symptoms, and there is some evidence that it improves sleep and overall well-being, but no research has looked into its effects in perimenopause. This study aims to examine the effects of 12-week magnesium hydroxide supplementation on cognition, sleep and psychological well-being in peri-menopausal women, with the results compared with those of a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-assess as healthy
- •Report experiencing troublesome peri-menopause symptoms in the past 6 months but not post-menopausal (defined as 12 months with no periods)
排除标准
- •Post-menopausal
- •Lactating, pregnant or seeking to become pregnant
- •Nut Allergy
- •Taken antidepressant/antianxiety medication or other medication with strong likelihood for effects on cognition or sleep in the past 6 months.
- •Habitual magnesium supplementation (defined as more than 3 consecutive days or 4 days in total). Will be excluded unless washout for 1 month.
- •Menopause symptoms have been medically induced.
- •Receiving gender-affirming hormone therapy.
研究组 & 干预措施
375mg magnesium hydroxide
Magnesium hydroxide capsule consumed for 84 days
干预措施: Magnesium hydroxide 375mg (Dietary Supplement)
Placebo
Placebo capsule consumed for 84 days
干预措施: Placebo (Other)
结局指标
主要结局
Numeric working memory task % accuracy
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Numeric working memory task reaction time
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
3-back task % accuracy
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
3-Back task reaction time
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Corsi blocks task score
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance.
Alphabetic working memory task % accuracy
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Alphabetic working memory task reaction time
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Word recognition % accuracy
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance.
Word recognition reaction time
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Picture recognition % accuracy
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory task. Measured as a percentage, with a higher score indicating better performance.
Picture recognition reaction time
时间窗: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
次要结局
- The Menopause-Specific Quality of Life Questionnaire (Hilditch, 1996)(Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.)
- Centre for Epidemiologic Studies Depression Scale (Radlof, 1997)(Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.)
- The State-Trait Anxiety Inventory, TRAIT subscale (Spielberger, 1983)(Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.)
- The Perceived Stress Scale (Cohen et al., 1983)(Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.)
- Visual Analogue Mood Scales (VAMS)(Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.)
- Sleep Related Impairment (PROMIS-SRI) (Yu et al., 2011)(Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.)
- Sleep Disturbance (PROMIS-SD) (Yu et al., 2011)(Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.)