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Active, not recruiting

NCT Number: NCT07814300

DBPCT Effects of Omega-3 FA on Memory and Cognition in Peri- and Menopausal Women

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Menopause

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's University

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Algae Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal Women

Dietary Supplement

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.

Primary outcomes

  1. Verbal Memory

    Time frame: From baseline to completion, up to 31 days

    Change in Memory scores from baseline to post-intervention, Rey Auditory Verbal Learning Test (RAVLT)

  2. Working memory

    Time frame: From baseline to completion, up to 31 days

    Change in memory from baseline to completion using the Digit Span Test

  3. Verbal Adaptation

    Time frame: From baseline to completion, up to 31 days

    Change in verbal adaptation from baseline to completion using the Stroop Test

Secondary outcomes

  1. Change in menopausal symptoms (quality of life)

    Time frame: From baseline to completion, up to 31 days

    Change in menopausal symptoms assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire.

  2. Change in subjective memory function

    Time frame: From baseline to completion, up to 31 days

    Change in self-reported memory lapses measured using the Prospective and Retrospective Memory Questionnaire (PRMQ).

  3. Dietary patterns

    Time frame: 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.

  4. Sleep patterns

    Time frame: 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.

  5. Stress levels

    Time frame: From baseline to completion, up to 31 days

    Change in self-reported stress levels are integrated in self-reported questionnaire

Sponsors and collaborators

Lead sponsor

St. Mary's University, Twickenham

Other

Collaborators

  • Cytoplan Ltd

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal Women

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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