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

NCT07235878 | Not Yet Recruiting

• 1 other identifier: 10251
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Perimenopause; Perimenopausal Women; Perimenopause, Climacteric Syndrome

Keywords

perimenopause; cognition; psychological wellbeing; sleep; magnesium; memory

Outcome Measures

Primary Outcomes (11)

• Numeric 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.

• Numeric working memory task 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 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.

• 3-Back task 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.

• 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.

• Alphabetic working memory task 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.

• 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.

Secondary Outcomes (7)

• 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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule consumed for 84 days

Other: Placebo

375mg magnesium hydroxide

EXPERIMENTAL

Magnesium hydroxide capsule consumed for 84 days

Dietary Supplement: Magnesium hydroxide 375mg

Interventions

Placebo OTHER

12 week placebo supplement of 2 capsules per day

Placebo

Magnesium hydroxide 375mg DIETARY_SUPPLEMENT

12 week supplementation of 2 capsules per day of Magnesium hydroxide

375mg magnesium hydroxide

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead
• Vitabiotics: collaborator

Study Sites (1)

School of Psychology, Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Interventions

Magnesium Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Magnesium Compounds

Central Study Contacts

Crystal Haskell-Ramsay

CONTACT

+44 191 2274875; crystal.haskell-ramsay@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active vs. placebo

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 19, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Fully accessible

Locations

GB (1)