Effects of 12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Northumbria University
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- 3-back % accuracy
Study Overview
Brief Summary
Perimenopause is a stage of transition into menopause that is marked by menopausal symptoms while menstruation is still taking place. Perimenopause symptoms include mood changes, anxiety, sleep disruptions, hot flushes, night sweats, fatigue, and cognitive challenges. The frequency and severity of these symptoms can seriously impair women's quality of life. Even if the public's awareness on menopause has increased, there are still a lot of unanswered questions. A connection between nutrition and menopause management has been proposed in earlier research. However, there is limited research in this field, and women frequently turn to social media for supplement recommendations in order to deal with menopause-related issues.
Vitamins and minerals such as vitamin D and calcium are recommended by the European Menopause and Andropause Society and there is limited evidence to suggests that soy and herbals may have a beneficial effect on menopausal symptoms, but more research is needed.
The aim of this study is to investigate the effects of 12-weeks multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being.
Detailed Description
Perimenopause is the stage of a woman's life when she has not yet gone a full year without her period but is still undergoing changes due to changing hormones. It often occurs in our 40s, but some women may experience it sooner. It is a normal aspect of aging. While each person experiences symptoms differently, some common ones include irregular periods, hot flushes, night sweats, mood swings, difficulty sleeping, decreased libido, vaginal dryness, memory and concentration problems, joint and muscle aches, fatigue, headaches, and changes in skin or hair.
Hormone replacement therapy (HRT), which is available through general practitioners and comes in a variety of forms, is currently the first line of treatment for menopause symptoms. However, some people might decide against using HRT because of adverse effects or because it's inappropriate for them for other reasons.
Supplement companies are starting to market to women who are increasingly using social media to seek advice on how to manage their symptoms by making claims that their products can lessen menopausal symptoms.
Although there is evidence linking nutrition to menopause, there are limited research on the subject, especially when it comes to perimenopause. The European Menopause and Andropause Society recommends vitamins and minerals including calcium and vitamin D. There is also some evidence that soy and herbal remedies like sage, green tea, and ashwaganda may help with menopausal symptoms, but more research is required.
The aim of this study is to investigate the effects of a multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being when taken for 3 months. These effects will be compared to the effects of an inert placebo taken over the same time frame.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- •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 multi-vitamin/mineral 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.
Arms & Interventions
Placebo
Placebo capsule consumed for 84 days
Intervention: Placebo (Other)
Multivitamin/mineral (1 Tablet)
Multivitamin/mineral supplement consumed for 84 days
Intervention: Multivitamin/mineral supplement (Dietary Supplement)
Outcomes
Primary Outcomes
3-back % accuracy
Time Frame: 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 % accuracy
Time Frame: 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.
Corsi blocks task score
Time Frame: 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
Time Frame: 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 reaction time
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Numeric working memory reaction time
Time Frame: 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 reaction time
Time Frame: 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.
Secondary Outcomes
- 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.)