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Healthy AgingPHAEOSOL-THREENCT04832412

Effect of BrainPhyt, a Microalgae Based Ingredient on Cognitive Function in Healthy Older Subjects

A study testing BrainPhyt and 100 % Maltodextrin in people with Healthy Aging and Dietary Supplement, run by Microphyt at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In developed countries, the acceleration of the general population ageing has been widely described for decades, involving changes in public health policies. Among the health issues arising from this demographic change, the maintenance of cognitive function will be a major challenge in the next years, both in societal… Read more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Aging, Dietary Supplement, Fucoxanthin
What is being tested?
BrainPhyt and 100 % Maltodextrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteIreland
Study dates
1 Sep 2022to 20 May 2023
Phase
Interventional
Are there results?
None posted in the registry

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 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Be able to give written informed consent and to consume the investigational product daily for the duration of the study.
  • Healthy males and females aged ≥ 55 and ≤ 75 years old.
  • Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
  • Have age-related mild cognitive decline, defined as:
  • Absence of dementia as determined by a score of ≥24 on the Mini Mental State Examination (MMSE).
  • A score on the MAC-Q of ≥25.
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  • Have a self-reported memory complaint.
  • Have an AD8 Dementia Screening Score of <2 (normal cognition).
  • Have a Hospital Anxiety and Depression Scale (HADS) score of ≤7 for both anxiety and depression.
  • Is in general good health, as determined by the investigator
  • Ability to comply with study protocol and complete computerised cognitive testing.
  • Willing to maintain their habitual diet and exercise routines.
  • Willing to maintain consistent sleep duration the evening before study visits.

Who cannot join

  • Women who are pregnant, breastfeeding, or wish to become pregnant during the study.
  • Female participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
  • Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
  • Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
  • sexual partner(s) is/are exclusively female.
  • Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 1 week following the end of the study.
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  • Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.
  • Individuals with dementia or mild cognitive impairment defined as greater than or equal to one standard deviation below the mean for age-matched norms on a standardised memory test
  • Individuals taking the following supplements who are unwilling to undergo a 4-week washout period: Ginkgo biloba, Ginseng, Choline, Taurine, Huperizine A, Acetyl-L-Carnitine, DMAE (Dimethylaminoethanol), Lecithin, Phosphatidylcholine, Phosphatidylderine, DHEA (Dehydroepiandrosterene), Alpha lipoic acid, Bacopa (Brahmi), CDP-choline (Citicoline), Alpha-GPC, Green tea extract, L-Tyrosine, or L-Theanine
  • Chronic use of oral or injectable corticosteroids
  • Untreated psychotic or major depressive disorder
  • Uncontrolled hypertension/diabetes
  • A significant history of cardiovascular complaints (e.g., angina)
  • A significant neurological disease
  • Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study.
  • History within previous 12 months of alcohol or substance abuse.
  • History of heavy smoking (>1 pack/day) within past 3 months.
  • History of heavy caffeinated beverage consumption (>400 mg caffeine/day) within past 2 weeks.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Atlantia Clinical Food trial

    Cork

Other trials in Ireland

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt on Cognitive Function in Healthy Older Subjects

In developed countries, the acceleration of the general population ageing has been widely described for decades, involving changes in public health policies. Among the health issues arising from this demographic change, the maintenance of cognitive function will be a major challenge in the next years, both in societal and economic terms. In this regard, some pharmacological and behavioural (e.g. physical activity, social involvement, intellectually demanding activities) preventive approaches have been evaluated to improve cognitive function with ageing. Among them, dietary interventions showed a potential interest to prevent cognitive decline during ageing. In this sense, there is a growing interest to find ecological solutions and to meet major societal challenge the use of microalgae as molecule of interest sources is a recent promising approach. Marine environments harbour a huge biological diversity of microalgae that represents a large source of almost untapped bioactive compounds. This biodiversity comprises 200,000 to 2 million species with about 35,000 which are described and 15,000 maintained in culture collections. Microalgae are able to produce bioactive molecules, such as pigments, fatty acids, peptides and sterols. Some of these compounds are unique and specifically found in the marine environment and they could be increasingly used as natural bioactive products for targeted applications. Fucoxanthin is one of the major carotenoid found in microalgae well known for its neuroprotective effect but to our knowledge no human studies were realized.

Thus the objective is to evaluate, in healthy older adults, the effect of a 24-week period of daily supplementation of high and low BrainPhyt, doses on cognitive function parameters (Spatial Working Memory scores, Attention and vigilance, episodic memory, executive function), stress, mood, sleep quality and biomarkers.

Being tested
BrainPhyt, 100 % Maltodextrin
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrainPhytDietary supplement

    BrainPhyt low dose supplementation during 6 months

  • 100 % MaltodextrinDietary supplement

    100 % Maltodextrin

Study groups in NCT04832412
Study groupRoleWhat they receive
BrainPhyt Low doseExperimental2 capsules of 275mg BrainPhyt for 24 weeks
Receives: Dietary Supplement: BrainPhyt
PlaceboPlacebo comparator2 capsules of 275mg Maltodextrin
Receives: Dietary Supplement: 100 % Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spatial working memory

    Change in spatial working memory scores - COMPASS cognitive assessment system

    Measured: From week 0 to week 24

Secondary outcomes (19)

  1. Spatial working memory

    Change in spatial working memory scores - COMPASS cognitive assessment system

    Measured: From week 0 to week 12

  2. Attention and vigilance

    Change in spatial working memory scores - COMPASS cognitive assessment system

    Measured: From week 0 to week 24

  3. Attention and vigilance

    Change in spatial working memory scores - COMPASS cognitive assessment system (Choice reaction time and digit vigilance tasks)

    Measured: From week 0 to week 12

  4. Executive function

    Change in Executive function scores - COMPASS cognitive assessment system (Stroop task)

    Measured: From week 0 to week 24

  5. Executive function

    Change in Executive function scores - COMPASS cognitive assessment system (Stroop task)

    Measured: From week 0 to week 12

  6. Episodic memory

    Change in Episodic memory scores - COMPASS cognitive assessment system (Picture and word recognition tasks)

    Measured: From week 0 to week 12

  7. Episodic memory

    Change in Episodic memory scores - COMPASS cognitive assessment system (Picture and word recognition tasks)

    Measured: From week 0 to week 24

  8. Sleep quality

    Change in Leeds sleep evaluation questionnaire score

    Measured: From week 0 to week 24

  9. Sleep quality

    Change in Leeds sleep evaluation questionnaire score

    Measured: From week 0 to week 12

  10. Mood state

    Change in Bond-Lader Mood Rating scale score

    Measured: From week 0 to week 24

  11. Mood state

    Change in Bond-Lader Mood Rating scale score

    Measured: From week 0 to week 12

  12. Stress state

    Change in Cohen's Perceived stress scale score

    Measured: From week 0 to week 24

  13. Stress state

    Change in Cohen's Perceived stress scale score

    Measured: From week 0 to week 12

  14. Blood TNFa level (pg/ml)

    Change in blood TNFa compared to baseline

    Measured: From week 0 to week 12 and week 24

  15. Blood IFN level (pg/ml)

    Change in blood IFN compared to baseline

    Measured: From week 0 to week 12 and week 24

  16. Blood CRP level (pg/ml)

    Change in blood CRP compared to baseline

    Measured: From week 0 to week 12 and week 24

  17. Blood IL6 level (pg/ml)

    Change in blood IL6 compared to baseline

    Measured: From week 0 to week 12 and week 24

  18. Blood Insulin level (mUI/l)

    Change in blood Insulin compared to baseline

    Measured: From week 0 to week 12 and week 24

  19. Blood HbA1C level (%)

    Change in blood HbA1C compared to baseline

    Measured: From week 0 to week 12 and week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start1 Sep 2022
  3. Primary completion20 May 2023
  4. Study completion20 May 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04832412
Sponsor's protocol ID
AFCRO-126
Acronym
PHAEOSOL-THREE
Status last verified
Dec 2024
First submitted
2 Apr 2021
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Goodbody E, Maury J, Doolan A, DunnGalvin G, Kakilla C, Pradelles R, Dinan TG. Promising benefits of six-month Phaeodactylum tricornutum microalgae supplementation on cognitive function and inflammation in healthy older adults with age-associated memory impairment. Front Aging. 2025 Apr 30;6:1540115. doi: 10.3389/fragi.2025.1540115. eCollection 2025.

    PubMed 40370669

Questions about this trial

What is this clinical trial studying?

A study testing BrainPhyt and 100 % Maltodextrin in people with Healthy Aging and Dietary Supplement, run by Microphyt at 1 site in Ireland.

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 13 inclusion and 18 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: finished, as of the sponsor's last update on 17 Dec 2024. 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 Ireland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Spatial working memory (time frame: From week 0 to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04832412, which also lists 1 linked publication.

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 17 Dec 2024.

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