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

NCT07242430 | Not Yet Recruiting

• 1 other identifier: 10806
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Perimenopause; Perimenopausal Women; Perimenopause, Climacteric Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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.

• 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 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

Multivitamin/mineral (1 Tablet)

EXPERIMENTAL

Multivitamin/mineral supplement consumed for 84 days

Dietary Supplement: Multivitamin/mineral supplement

Interventions

Placebo OTHER

12 week placebo supplement of 1 tablet per day

Placebo

Multivitamin/mineral supplement DIETARY_SUPPLEMENT

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

Multivitamin/mineral (1 Tablet)

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 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.

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

Geritol

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: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 21, 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)