Menopause Other
Conditions
Interventions
The participant receives Vitals+, a commercially available multivitamin supplement (Heights, Braincare Limited, London), at a dose of two capsules per day for 12 weeks. The supplement contains 12 vita
Sponsors
University of East Anglia
Eligibility
Sex/Gender
Female
Age
45 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Female aged 45–55 years 2. Perimenopausal (as defined by NICE Menopause guidelines 2024) for at least 2 years 3. Free from major neuropsychiatric conditions (e.g., depression), neurological conditions (e.g. multiple sclerosis), and gynaecological conditions (e.g., endometriosis) 4. Able to provide informed consent 5. Willing to undergo the full study protocol, including 32 clinic visits, MRI scanning, and biological sample collection
Exclusion criteria
Exclusion criteria: 1. Currently taking hormone replacement therapy (HRT) 2. Use of any nutritional supplements within the last 3 months 3. Consumption of more than 1 portion of oily fish per month AND red blood cell omega-3 index >6% 4. Consumption of more than 4 portions of fruit and vegetables per day 5. Consumption of more than 4 portions of B-vitamin fortified foods per week 6. Contraindication to MRI (e.g. metallic implants, pacemaker, cochlear implant, severe claustrophobia) 7. Postmenopausal (no menstrual cycle for =12 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognition measured using a validated neuropsychological battery covering verbal memory (Wechsler Memory Scale), verbal episodic memory (WMS-IV Logical Memory), working memory (Digit Span, WAIS-IV), verbal fluency and executive function (COWAT, Trail Making Test A and B, Hayling Sentence Completion), sustained attention (SART), and spatial navigation (Virtual Supermarket Test), delivered online and in person, at weekly during the 8-week pre-intervention baseline phase (weeks 1–8) and weekly during the 8-week post-intervention phase (weeks 21–28);Mental wellbeing measured using Profile of Mood States (POMS) at weekly during the 8-week pre-intervention baseline phase (weeks 1–8) and weekly during the 8-week post-intervention phase (weeks 21–28) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cerebral blood flow measured using MRI arterial spin labelling (ASL) at weeks 7 and 8 of each 8-week assessment phase (i.e. weeks 7, 8, 27 and 28);Brain neural activity measured using functional MRI (fMRI) at each of 32 clinic visits across weeks 1–8 (pre-intervention) and weeks 21–28 (post-intervention);Brain volume measured using MRI at weeks 7 and 8 of each 8-week assessment phase (weeks 7, 8, 27 and 28);Omega-3 index measured using gas chromatography at the beginning and end of each 8-week assessment phase (weeks 1, 8, 21 and 28) | — |
Countries
England, United Kingdom
Contacts
Public ContactAnne-Marie Minihane
Outcome results
None listed