12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being.

Effects of 12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Perimenopause; Perimenopause, Climacteric Syndrome; Perimenopausal Women
• Intervention / Treatment: Other: Placebo; Dietary supplement: Multivitamin/mineral supplement

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 Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Crystal Haskell-Ramsay; Phone Number: +44 191 2274875; Email: crystal.haskell-ramsay@northumbria.ac.uk

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 8ST
    • Recruiting
    • School of Psychology, Northumbria University
    • Contact: Crystal Haskell-Ramsay; Phone Number: +44 191 2274875; Email: crystal.haskell-ramsay@northumbria.ac.uk
    • Contact: Fiona Dodd; Email: f.dodd@northumbria.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsule consumed for 84 days	Other: Placebo; 12 week placebo supplement of 1 tablet per day
Experimental: Multivitamin/mineral (1 Tablet); Multivitamin/mineral supplement consumed for 84 days	Dietary supplement: Multivitamin/mineral supplement; 12 week supplementation of 1 tablet per day of multivitamin/mineral supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corsi blocks task score	Cognitive function - working memory task. Scored as level of difficulty reached (4 upwards), with a higher score indicating better performance.	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.	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.	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.	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.	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.	Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.
Numeric working memory % accuracy	Cognitive function - working memory task. Measured as a percentage, with a higher score indicating better performance.	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.	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.	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.	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.	Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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'.	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.	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.	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'.	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'.	Conducted at baseline (pre-dose), at 6 weeks post-dose, and at 12 weeks post-dose.

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Vitabiotics

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: memory; sleep; cognition; magnesium; perimenopause; psychological wellbeing
• Additional Relevant MeSH Terms: Geritol
• Other Study ID Numbers: 10806 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available 3 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Access Criteria: Fully accessible
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No