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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorNorthumbria University

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Placebo
  • Multivitamin/mineral supplement

Treatment groups

58 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Northumbria University

Lead sponsor

Vitabiotics

Collaborator