12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being

NCT ID: NCT07235878

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2026-08-01

Brief Summary

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.

Detailed Description

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.

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 2 capsules per day

375mg magnesium hydroxide

Magnesium hydroxide capsule consumed for 84 days

Group Type: EXPERIMENTAL

Magnesium hydroxide 375mg

Intervention Type: DIETARY_SUPPLEMENT

12 week supplementation of 2 capsules per day of Magnesium hydroxide

Interventions

Placebo

12 week placebo supplement of 2 capsules per day

Intervention Type: OTHER

Magnesium hydroxide 375mg

12 week supplementation of 2 capsules per day of Magnesium hydroxide

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 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.

• 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

10251

Identifier Type: -

Identifier Source: org_study_id