RecruitingNot ApplicableNCT07242430

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


Sponsor

Northumbria University

Enrollment

58 participants

Start Date

Apr 7, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 40 YearsMax Age: 60 Years

Inclusion Criteria2

  • 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 Criteria7

  • 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.

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Interventions

OTHERPlacebo

12 week placebo supplement of 1 tablet per day

DIETARY_SUPPLEMENTMultivitamin/mineral supplement

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


Locations(1)

School of Psychology, Northumbria University

Newcastle upon Tyne, United Kingdom

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NCT07242430


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