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

NCT ID: NCT07242430

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2026-08-01

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.

Conditions

Perimenopause; Perimenopausal Women; Perimenopause, Climacteric Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo capsule consumed for 84 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

12 week placebo supplement of 1 tablet per day

Multivitamin/mineral (1 Tablet)

Multivitamin/mineral supplement consumed for 84 days

Group Type: EXPERIMENTAL

Multivitamin/mineral supplement

Intervention Type: DIETARY_SUPPLEMENT

12 week supplementation of 1 tablet per day of multivitamin/mineral supplement

Interventions

Placebo

12 week placebo supplement of 1 tablet per day

Intervention Type: OTHER

Multivitamin/mineral supplement

12 week supplementation of 1 tablet per day of multivitamin/mineral supplement

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vitabiotics

UNKNOWN

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

School of Psychology, Northumbria University

Newcastle upon Tyne, , United Kingdom

Countries

United Kingdom

Central Contacts

Crystal Haskell-Ramsay

Role: CONTACT

crystal.haskell-ramsay@northumbria.ac.uk

+44 191 2274875

Facility Contacts

Crystal Haskell-Ramsay

Role: primary

crystal.haskell-ramsay@northumbria.ac.uk

+44 191 2274875

Fiona Dodd

Role: backup

f.dodd@northumbria.ac.uk

Other Identifiers

10806

Identifier Type: -

Identifier Source: org_study_id