An interventional study of Placebo and Multivitamin/mineral supplement in Perimenopause, Perimenopausal Women and Perimenopause, Climacteric Syndrome, sponsored by Northumbria University. Active, not recruiting at 1 site in United Kingdom. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Northumbria University · Not applicable, Interventional, and Other
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.
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.
Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo capsule consumed for 84 days
Other: Placebo
Multivitamin/mineral supplement consumed for 84 days
Dietary Supplement: Multivitamin/mineral supplement
12 week placebo supplement of 1 tablet per day
12 week supplementation of 1 tablet per day of multivitamin/mineral supplement
Numeric working memory % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Numeric working memory reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
3-back % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
3-Back reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Corsi blocks task score
Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Alphabetic working memory task % accuracy
Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Alphabetic working memory reaction time
Cognitive function - working memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Word recognition % accuracy
Cognitive function - episodic memory. Measured as a percentage, with a higher score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Word recognition reaction time
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Picture recognition % accuracy
Cognitive function - episodic memory task. Measured as a percentage, with a higher score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Picture recognition reaction time
Cognitive function - episodic memory task. Measured as reaction time (in milliseconds), with a lower score indicating better performance.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
The Menopause-Specific Quality of Life Questionnaire (Hilditch, 1996)
Assesses the effect of menopausal symptoms on quality of life in four domains: vasomotor, psychosocial, physical, and sexual; as well as providing a total score. The questionnaire has 29 items, each item is a symptom of menopause, the participants rate each symptom between 0 (not at all bothered) to 6 (bothered all the time.) The vasomotor symptoms include items such as 'hot flushes' and 'sweating'; psychological symptoms include 'accomplishing less than I used to' and 'poor memory'; physical symptoms include 'difficulty sleeping' and 'weight gain'; sexual symptoms include 'vaginal dryness' and 'avoiding intimacy'. A conversion score is created for each of the 4 domains: vasomotor; psychosocial; physical; sexual; as well as a total score. Each score ranges from 1 -8, with higher scores indicating greater problems.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Centre for Epidemiologic Studies Depression Scale (Radlof, 1997)
This is an established questionnaire used to measure symptoms associated with depression. The questionnaire has 20 items, including 'my sleep is restless', 'I felt depressed' and 'I felt lonely'. The participants rate the symptom on a scale between \<1 day and 5 to 7 days, the 4 scale points are: Rarely or none of the time (less than 1 day); Some or a little of the time (1-2 days); Occasionally or a moderate amount of time (3-4 days); Most or all of the time (5-7 days). The possible range of scores is between 0 to 60, higher scores indicate more presence of symptomatology. The scoring of positive items is reversed.
Time frame: 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)
The state-trait anxiety inventory will be used to measure anxiety levels, specifically trait anxiety. It consists of 20 items and the scale ranges from 1 to 4: 1 = almost never, 2 = sometimes, 3 = often and 4 = almost always. The nine positive items will be reversed for scoring, items 21, 23, 26, 27, 30, 33, 34, 36 and 39. The possible range of scores is 20 to 80, higher scores indicate higher levels of trait anxiety within the participant. Examples of items within the questionnaire include: 'I feel like a failure' and 'I feel secure'.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
The Perceived Stress Scale (Cohen et al., 1983)
This established questionnaire will be used to measure the perception of stress. Each of the ten items are rated on a scale between 0 (never) to 4 (very often.) The five scale points are 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often. The four positive items will be reversed for scoring, items 4, 5, 7 and 8. The questionnaire item examples include 'In the last month, how often have you been upset because of something that happened unexpectedly?' and 'In the last month, how often have you felt that you were unable to control the important things in your life?'. The possible range of scores is between 0 to 40, higher scores indicate high participant perceived stress.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Visual Analogue Mood Scales (VAMS)
This is a series of mood scales. Each scale is a line anchored at either side by an adjective describing a mood. Participants must click at a point on the scale that represents how they are feeling at that point in time. There are 18 scales in total, each scored out of 100. From these scales three composite scores are calculated describing feelings of 'Alertness', 'Stress' and 'Tranquillity', which are also presented as a score out of 100.
Time frame: 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)
The PROMIS-SRI will be used to measure sleep related impairment. The questionnaire contains 8 items, and participants are required to answer in relation to their sleep within the past 7 days. Each item is rated on a scale from 1-5. The items are then summed to create a single value (range 8-40), with higher scores indicating higher levels of sleep disturbance. Examples of items within the questionnaire include: 'I felt alert when I woke up' and 'I had a hard time getting things done because I was sleepy'.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Sleep Disturbance (PROMIS-SD) (Yu et al., 2011)
The PROMIS-SD will be used to measure sleep disturbance. The questionnaire contains 8 items, and participants are required to answer in relation to their sleep within the past 7 days. Each item is rated on a scale from 1-5. The items are then summed to create a single value (range 8-40), with higher scores indicating higher levels of sleep disturbance. Examples of items within the questionnaire include: 'my sleep was restless' and 'I had difficulty falling asleep'.
Time frame: Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Plan to share: Yes — An anonymised dataset will be shared on this platform within the results section. Any information which may identify individual participants will be removed from the dataset before it is shared. Data will be shared in accordance with FAIR (findable, accessible, interoperable, reusable) principles. Participants will consent to the data being shared in this way.
Supporting information: Study protocol, Sap, Icf
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Northumbria University