MenopauseNCT07814300
DBPCT Effects of Omega-3 FA on Memory and Cognition in Peri- and Menopausal Women
A study of Menopause, run by St. Mary's University, Twickenham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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:
- -Does omega-3 supplementation improve memory and cognitive performance?
- - 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.
- Conditions
- Menopause
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Algae Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal WomenDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Algea Omega-3 supplements (950mg DHA, 350mg EPA) (Cytoplan Ltd- high strenght) | Experimental | Not described Receives: 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 | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Memory
Change in Memory scores from baseline to post-intervention, Rey Auditory Verbal Learning Test (RAVLT)
Measured: From baseline to completion, up to 31 days
Working memory
Change in memory from baseline to completion using the Digit Span Test
Measured: From baseline to completion, up to 31 days
Verbal Adaptation
Change in verbal adaptation from baseline to completion using the Stroop Test
Measured: From baseline to completion, up to 31 days
Secondary outcomes (5)
Change in menopausal symptoms (quality of life)
Change in menopausal symptoms assessed using the Menopause-Specific Quality of Life (MENQOL) questionnaire.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: From baseline to completion, up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start25 Mar 2026
- Primary completion30 Aug 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Mary's University, Twickenham
- Sponsor type
- University, hospital or other
- Collaborators
- Cytoplan Ltd
- Responsible party
- Principal investigator, Magali Chohan, St. Mary's University, Twickenham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814300
- Sponsor's protocol ID
- SMU_ETHICS_2025-26_305
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07814300
- Acronym / sponsor ID
- SMU_ETHICS_2025-26_305
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- St. Mary's University, TwickenhamUniversity, hospital or other
- Collaborators
- Cytoplan Ltd
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- -Does omega-3 supplementation improve memory and cognitive performance?
- - 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Algae Omega-3 Fatty Acids on Memory and Cognition in Perimenopausal and Menopausal WomenThe 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. | Dietary supplement | Algea Omega-3 supplements (950mg DHA, 350mg EPA) (Cytoplan Ltd- high strenght), Placebo (1000mg high oleic sunflower oil) (Phytoppharma.eu) |
Primary outcome
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)
Working memory
Time frame: From baseline to completion, up to 31 days
Change in memory from baseline to completion using the Digit Span Test
Verbal Adaptation
Time frame: From baseline to completion, up to 31 days
Change in verbal adaptation from baseline to completion using the Stroop Test
5 secondary outcomes
Change in menopausal symptoms (quality of life)
Time frame: From baseline to completion, up to 31 days
Change in subjective memory function
Time frame: From baseline to completion, up to 31 days
Dietary patterns
Time frame: From baseline to completion, up to 31 days
Sleep patterns
Time frame: Baseline (Week 0; 7-day recording period prior to intervention)End of intervention (Week 12; 7-day recording period)
Stress levels
Time frame: From baseline to completion, up to 31 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Menopause
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Menopause, run by St. Mary's University, Twickenham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Memory (time frame: From baseline to completion, up to 31 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.