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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
42
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.
St Mary's University
London, United Kingdom
Verbal Memory
Change in Memory scores from baseline to post-intervention, Rey Auditory Verbal Learning Test (RAVLT)
Time frame: From baseline to completion, up to 31 days
Working memory
Change in memory from baseline to completion using the Digit Span Test
Time frame: From baseline to completion, up to 31 days
Verbal Adaptation
Change in verbal adaptation from baseline to completion using the Stroop Test
Time frame: From baseline to completion, up to 31 days
Change in menopausal symptoms (quality of life)
Change in menopausal symptoms assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire.
Time frame: From baseline to completion, up to 31 days
Change in subjective memory function
Change in self-reported memory lapses measured using the Prospective and Retrospective Memory Questionnaire (PRMQ).
Time frame: From baseline to completion, up to 31 days
Dietary patterns
Dietary patterns assessed using a short Food Frequency Questionnaire to account for habitual nutrient intake that may influence outcomes.
Time frame: From baseline to completion, up to 31 days
Sleep patterns
Change in sleep duration, sleep quality, and number of night-time awakenings, recorded using daily sleep diaries over 7 consecutive days.
Time frame: Baseline (Week 0; 7-day recording period prior to intervention)End of intervention (Week 12; 7-day recording period)
Stress levels
Change in self-reported stress levels are integrated in self-reported questionnaire
Time frame: From baseline to completion, up to 31 days
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