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

Northumbria University

Status: Not yet enrolling

Conditions: Perimenopausal Women; Perimenopause, Climacteric Syndrome; Perimenopause

Treatments: Other: Placebo; Dietary Supplement: Multivitamin/mineral supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07242430

10806 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Perimenopause is the stage of a woman's life when she has not yet gone a full year without her period but is still undergoing changes due to changing hormones. It often occurs in our 40s, but some women may experience it sooner. It is a normal aspect of aging. While each person experiences symptoms differently, some common ones include irregular periods, hot flushes, night sweats, mood swings, difficulty sleeping, decreased libido, vaginal dryness, memory and concentration problems, joint and muscle aches, fatigue, headaches, and changes in skin or hair.

Hormone replacement therapy (HRT), which is available through general practitioners and comes in a variety of forms, is currently the first line of treatment for menopause symptoms. However, some people might decide against using HRT because of adverse effects or because it's inappropriate for them for other reasons.

Supplement companies are starting to market to women who are increasingly using social media to seek advice on how to manage their symptoms by making claims that their products can lessen menopausal symptoms.

Although there is evidence linking nutrition to menopause, there are limited research on the subject, especially when it comes to perimenopause. The European Menopause and Andropause Society recommends vitamins and minerals including calcium and vitamin D. There is also some evidence that soy and herbal remedies like sage, green tea, and ashwaganda may help with menopausal symptoms, but more research is required.

The aim of this study is to investigate the effects of a multi-vitamin/mineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being when taken for 3 months. These effects will be compared to the effects of an inert placebo taken over the same time frame.

Enrollment: 58 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsule consumed for 84 days

Treatment:

Other: Placebo

Multivitamin/mineral (1 Tablet)

Experimental group

Description:

Multivitamin/mineral supplement consumed for 84 days

Treatment:

Dietary Supplement: Multivitamin/mineral supplement