Age-associated Memory ImpairmentPHAEO-FOURNCT05759910
Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
A study testing Brainphyt high dose in people with Age-associated Memory Impairment, run by Microphyt at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline. Read more about this study
- Who is it for?
- Ages 55 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-associated Memory Impairment
- What is being tested?
- Brainphyt high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- 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.
- Body-mass index between 18.5 and 35.0 kg/m2
- Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
- Have age-associated memory impairment (AAMI) based on the following National Institute of Mental Health criteria, specified as scoring:
- Absence of dementia as determined by a score of >24 on the Mini Mental State Examination (MMSE).
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- ≤29 or ≤9 on the VPA I and II portions of the Wechsler Memory Scale IV, respectively
- A score on the MAC-Q of ≥25.
- Is in general good health, as determined by the investigator
- Ability to comply and understand the cognitive function practice tests
- Willing to maintain their habitual diet and exercise routines.
- Willing to maintain consistent sleep duration the evening before study visits.
Who cannot join
- Use of medications or supplements known to alter cognitive function within past 2 weeks
- Abnormal clinical laboratory test that may affect study outcome.
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurological disorders (including sleep disorders, head injuries, Alzheimer's disease, Parkinson's disease, stroke, inflammatory brain disease
- History or presence of cancer, except nonmelanoma skin cancer
- Uncontrolled hypertension/diabetes
- History of depression within past 24 months or use of psychotropic medications within 1 month of screening
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise & Sport Nutrition Lab
College Station, Texas, 77843-4253
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
The purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline.
In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.
- Conditions
- Age-associated Memory Impairment
- Being tested
- Brainphyt high dose, Placebo
- Keywords
- Elderly, Microalgae, Cognitive function, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brainphyt high doseDietary supplement
Participants will take BrainPhyt capsules during 3 months
PlaceboDietary supplement
Participants will take placebo capsules during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | 4 capsules per day containing 275mg of Maltodextrin Receives: Dietary Supplement: Placebo |
| BrainPhyt High dose | Experimental | 4 capsules per day containing 275mg of BrainPhyt Receives: Dietary Supplement: Brainphyt high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spatial Working Memory
Mean Span Score in Corsi Blocks module of the COMPASS
Measured: From week 0 to week 12
Secondary outcomes (17)
Change in spatial working memory
Mean Span Score in Corsi Blocks module of the COMPASS
Measured: From week 0 to week 4
Change in attention and vigilance
Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS
Measured: From week 0 to week 12
Change in attention and vigilance
Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS
Measured: From week 0 to week 4
Change in executive function
Mean reaction time and accuracy in Stroop task module of the COMPASS
Measured: From week 0 to week 12
Change in executive function
Mean reaction time and accuracy in Stroop task module of the COMPASS
Measured: From week 0 to week 4
Change in episodic memory
Mean reaction time and accuracy in Stroop task module of the COMPASS
Measured: From week 0 to week 12
Change in episodic memory
Mean reaction time and accuracy in Stroop task module of the COMPASS
Measured: From week 0 to week 4
Change in perceptual and cognitive skills
Mean reaction time and accuracy in Neurotracker light reaction test
Measured: From week 0 to week 4
Change in perceptual and cognitive skills
Mean reaction time and accuracy in Neurotracker light reaction test
Measured: From week 0 to week 12
Stress level
Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress)
Measured: From week 0 to week 4
Stress level
Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress)
Measured: From week 0 to week 12
Sleep quality
Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality)
Measured: From week 0 to week 12
Sleep quality
Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality)
Measured: From week 0 to week 4
Mood state
Change Bond-Lader Mood rating scale from 0 to 10 (low mood state)
Measured: From week 0 to week 4
Mood state
Change Bond-Lader Mood rating scale from 0 to 10 (low mood state)
Measured: From week 0 to week 12
Inflammation IL-6
Change Interleukin-6 level (pg/ml)
Measured: from week 0 to week 12
Inflammation IL-6
Change Interleukin-6 level (pg/ml)
Measured: from week 0 to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 May 2022
- Primary completion1 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-associated Memory ImpairmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microphyt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Richard Kreider, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759910
- Sponsor's protocol ID
- IRB2021-1360F
- Acronym
- PHAEO-FOUR
- Status last verified
- Nov 2023
- First submitted
- 23 Feb 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoo C, Maury J, Gonzalez DE, Ko J, Xing D, Jenkins V, Dickerson B, Leonard M, Estes L, Johnson S, Chun J, Broeckel J, Pradelles R, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Supplementation with a Microalgae Extract from Phaeodactylum tricornutum Containing Fucoxanthin on Cognition and Markers of Health in Older Individuals with Perceptions of Cognitive Decline. Nutrients. 2024 Sep 5;16(17):2999. doi: 10.3390/nu16172999.
PubMed 39275314
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
- ClinicalTrials.gov ID
- NCT05759910
- Acronym / sponsor ID
- PHAEO-FOUR / IRB2021-1360F
- Conditions
- Age-associated Memory Impairment
- Keywords
- Elderly, Microalgae, Cognitive function, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MicrophytIndustry (pharma, biotech, devices)
- Collaborators
- Texas A&M University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 8 Mar 2023 (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 purpose of this study is to evaluate if BrainPhyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline.
In a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest Brainphyt supplement or Placebo for 12 weeks. Cognitive function battery will be realized after 4 and 12 weeks of supplementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Placebo4 capsules per day containing 275mg of Maltodextrin |
| BrainPhyt High dose | Experimental | Dietary Supplement: Brainphyt high dose4 capsules per day containing 275mg of BrainPhyt |
Who may qualify
- Ages
- 55 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
- Body-mass index between 18.5 and 35.0 kg/m2
- Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
- Have age-associated memory impairment (AAMI) based on the following National Institute of Mental Health criteria, specified as scoring:
Key exclusion criteria (9 listed)
- Use of medications or supplements known to alter cognitive function within past 2 weeks
- Abnormal clinical laboratory test that may affect study outcome.
- History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurological disorders (including sleep disorders, head injuries, Alzheimer's disease, Parkinson's disease, stroke, inflammatory brain disease
- History or presence of cancer, except nonmelanoma skin cancer
- Uncontrolled hypertension/diabetes
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 |
|---|---|---|
| Brainphyt high doseParticipants will take BrainPhyt capsules during 3 months | Dietary supplement | BrainPhyt High dose |
| PlaceboParticipants will take placebo capsules during 3 months | Dietary supplement | Placebo group |
Primary outcome
Change in spatial Working Memory
Time frame: From week 0 to week 12
Mean Span Score in Corsi Blocks module of the COMPASS
17 secondary outcomes
Change in spatial working memory
Time frame: From week 0 to week 4
Change in attention and vigilance
Time frame: From week 0 to week 12
Change in attention and vigilance
Time frame: From week 0 to week 4
Change in executive function
Time frame: From week 0 to week 12
Change in executive function
Time frame: From week 0 to week 4
Change in episodic memory
Time frame: From week 0 to week 12
Change in episodic memory
Time frame: From week 0 to week 4
Change in perceptual and cognitive skills
Time frame: From week 0 to week 4
Change in perceptual and cognitive skills
Time frame: From week 0 to week 12
Stress level
Time frame: From week 0 to week 4
Stress level
Time frame: From week 0 to week 12
Sleep quality
Time frame: From week 0 to week 12
Sleep quality
Time frame: From week 0 to week 4
Mood state
Time frame: From week 0 to week 4
Mood state
Time frame: From week 0 to week 12
Inflammation IL-6
Time frame: from week 0 to week 12
Inflammation IL-6
Time frame: from week 0 to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 39275314Yoo C, Maury J, Gonzalez DE, Ko J, Xing D, Jenkins V, Dickerson B, Leonard M, Estes L, Johnson S, Chun J, Broeckel J, Pradelles R, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Supplementation with a Microalgae Extract from Phaeodactylum tricornutum Containing Fucoxanthin on Cognition and Markers of Health in Older Individuals with Perceptions of Cognitive Decline. Nutrients. 2024 Sep 5;16(17):2999. doi: 10.3390/nu16172999.
- Individual participant dataSharing planned: No
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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.
Richard Kreider, PhD principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brainphyt high dose in people with Age-associated Memory Impairment, run by Microphyt at 1 site in United States.
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 12 inclusion and 9 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 8 Nov 2023. 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 States. 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?
Change in spatial Working Memory (time frame: From week 0 to week 12). 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 NCT05759910, 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 8 Nov 2023.