Menopause
Conditions
Brief summary
The goal of this clinical trial is to learn if daily omega-3 supplementation improves memory and cognitive function in perimenopausal and menopausal women aged 40-60 years. It will also assess whether omega-3 supplements influence menopausal symptoms, stress levels, and sleep patterns. The main questions it aims to answer are: 1. -Does omega-3 supplementation improve memory and cognitive performance? 2. \- Does omega-3 supplementation affect menopausal symptoms, stress, and perceived memory changes? 3- Are there any differences in sleep patterns during supplementation? Researchers will compare omega-3 supplements to a placebo to see if omega-3 improves memory and cognition.
Interventions
DIETARY_SUPPLEMENTA Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Algae Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal Women
The intervention consists of daily supplementation with a DHA-dominant omega-3 algae based formulation (approximately 950 mg DHA and 350 mg EPA) for 12 weeks. This dose (\>1 g/day) is selected based on evidence suggesting higher omega-3 intake is required to influence cognitive outcomes. The study targets perimenopausal and menopausal women aged 40-60 years, a population experiencing hormonally related cognitive changes. The comparator is a matched placebo (high oleic refined sunflower oil, 1000 mg), selected for its inert fatty acid profile and absence of DHA/EPA. Capsules are identical in appearance and dosing to maintain blinding. The DHA-focused formulation, specific population, and combined cognitive, questionnaire, and sleep assessments distinguish this intervention from other omega-3 studies.
Sponsors
St. Mary's University, Twickenham
Cytoplan Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Be female and aged between 40-60 years * Be experiencing perimenopause or menopause * Access to reliable internet connection and a device to complete online questionnaires and cognitive assessments * Be prepared to take a daily omega-3 supplement or placebo for 12 weeks * Be prepared to complete pre- and post- intervention testing and questionnaires * Speak English fluently to confirm they can complete cognitive tests to the best of their ability
Exclusion criteria
* Have diagnosed psychiatric or neurological condition (dementia, extreme depression, schizophrenia, bipolar disorder) which could affect cognitive function * Not currently be taking omega-3 supplements or regularly consuming fatty fish (1 portion per/week) * Be using hormone replacement therapy (HRT) * Have severe dietary restrictions * Have a history of stroke, cardiovascular disease or diabetes, as these conditions influence cognitive health * Are unable to commit to both baseline and follow-up tests after the 12-week period * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Memory | From baseline to completion, up to 31 days | Change in Memory scores from baseline to post-intervention, Rey Auditory Verbal Learning Test (RAVLT) |
| Working memory | From baseline to completion, up to 31 days | Change in memory from baseline to completion using the Digit Span Test |
| Verbal Adaptation | From baseline to completion, up to 31 days | Change in verbal adaptation from baseline to completion using the Stroop Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in menopausal symptoms (quality of life) | From baseline to completion, up to 31 days | Change in menopausal symptoms assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire. |
| Change in subjective memory function | From baseline to completion, up to 31 days | Change in self-reported memory lapses measured using the Prospective and Retrospective Memory Questionnaire (PRMQ). |
| Dietary patterns | From baseline to completion, up to 31 days | Dietary patterns assessed using a short Food Frequency Questionnaire to account for habitual nutrient intake that may influence outcomes. |
| Sleep patterns | Baseline (Week 0; 7-day recording period prior to intervention)End of intervention (Week 12; 7-day recording period) | Change in sleep duration, sleep quality, and number of night-time awakenings, recorded using daily sleep diaries over 7 consecutive days. |
| Stress levels | From baseline to completion, up to 31 days | Change in self-reported stress levels are integrated in self-reported questionnaire |
Countries
United Kingdom
Outcome results
None listed