Actively Recruiting
Effects of 12-week Multi-vitamin/Mineral Supplementation on Perimenopause Symptoms, Cognition, Sleep, and Psychological Well-being: A Randomized Placebo-controlled Trial
Led by Northumbria University · Updated on 2026-05-29
58
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Northumbria University
Lead Sponsor
V
Vitabiotics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Perimenopause is a transition phase before menopause, marked by symptoms such as mood changes, anxiety, sleep problems, hot flushes, night sweats, fatigue, and cognitive challenges. These symptoms can significantly impact women's quality of life. Although awareness of menopause has grown, research on nutritional approaches to manage these symptoms remains limited. This study aims to evaluate the impact of a 12-week multi-vitamin/mineral and herbal supplement on perimenopause symptoms, memory, concentration, sleep, and psychological well-being compared to a placebo. Participants will be randomly assigned to one of two groups: one taking a placebo capsule daily for 84 days, and the other taking a multi-vitamin/mineral supplement daily for the same duration. The supplement includes herbal extracts and vitamins recommended by menopause societies. The study will compare the effects of these supplements on symptoms and cognitive function over the 12-week period. Throughout the study, participants will be assessed at the start, at 6 weeks, and at 12 weeks. Assessments include various memory and cognitive tests such as numeric and alphabetic working memory, 3-back task, word and picture recognition, as well as questionnaires on menopause quality of life, depression, anxiety, stress, mood, and sleep quality. The study monitors changes in these areas to understand the supplement's effects on perimenopausal women aged 40 to 60 years.
CONDITIONS
Brief Title
12-week Multi-vitamin/Mineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-assess as healthy
- Report experiencing troublesome perimenopause symptoms in the past 6 months
- Have not gone 12 months without menstruation (not post-menopausal)
- Female aged 40 to 60 years
You will not qualify if you...
- Post-menopausal (12 months with no periods)
- Pregnant, lactating, or seeking to become pregnant
- Nut allergy
- Taken antidepressant, antianxiety, or other medications likely to affect cognition or sleep in past 6 months
- Habitual multi-vitamin/mineral supplementation unless a 1-month washout period
- Menopause symptoms medically induced
- Receiving gender-affirming hormone therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take a daily multivitamin/mineral supplement or placebo for 12 weeks to assess effects on perimenopause symptoms, cognition, sleep, and psychological well-being.
3 visits (baseline, 6 weeks, and 12 weeks; in-person or remote assessments)
Trial Site Locations
Total: 1 location
1
School of Psychology, Northumbria University
Newcastle upon Tyne, United Kingdom, NE1 8ST
Actively Recruiting
Research Team
C
Crystal Haskell-Ramsay
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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