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

NCT07814300 | Active Not Recruiting

• 1 other identifier: SMU_ETHICS_2025-26_305
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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. 1.-Does omega-3 supplementation improve memory and cognitive performance?
2. 2.\- Does omega-3 supplementation affect menopausal symptoms, stress, and perceived memory changes? 3- Are there any differences in sleep patterns during supplementation?

Conditions

Menopause

Outcome Measures

Primary Outcomes (3)

• Verbal Memory

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

  From baseline to completion, up to 31 days

• Working memory

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

  From baseline to completion, up to 31 days

• Verbal Adaptation

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

  From baseline to completion, up to 31 days

Secondary Outcomes (5)

• Change in menopausal symptoms (quality of life)

  From baseline to completion, up to 31 days

• Change in subjective memory function

  From baseline to completion, up to 31 days

• Dietary patterns

  From baseline to completion, up to 31 days

• Sleep patterns

  Baseline (Week 0; 7-day recording period prior to intervention)End of intervention (Week 12; 7-day recording period)

• Stress levels

  From baseline to completion, up to 31 days

Study Arms (2)

Algea Omega-3 supplements (950mg DHA, 350mg EPA) (Cytoplan Ltd- high strenght)

EXPERIMENTAL

Dietary Supplement: 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

Placebo (1000mg high oleic sunflower oil) (Phytoppharma.eu)

PLACEBO COMPARATOR

Dietary Supplement: 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

Interventions

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.

Algea Omega-3 supplements (950mg DHA, 350mg EPA) (Cytoplan Ltd- high strenght); Placebo (1000mg high oleic sunflower oil) (Phytoppharma.eu)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Participants must be female and experiencing perimenopause or menopause symptoms
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Mary's University, Twickenham: lead
• Cytoplan Ltd: collaborator

Study Sites (1)

St Mary's University

London, United Kingdom

Location

MeSH Terms

Interventions

Double-Blind Method

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: September 10, 2026
• Study Start: March 25, 2026
• Primary Completion: August 30, 2026
• Study Completion: October 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

GB (1)