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| Name | Class |
|---|---|
| Texas A&M University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | 4 capsules per day containing 275mg of Maltodextrin |
|
| BrainPhyt High dose | Experimental | 4 capsules per day containing 275mg of BrainPhyt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brainphyt high dose | Dietary Supplement | Participants will take BrainPhyt capsules during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in spatial Working Memory | Mean Span Score in Corsi Blocks module of the COMPASS | From week 0 to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spatial working memory | Mean Span Score in Corsi Blocks module of the COMPASS | From week 0 to week 4 |
| Change in attention and vigilance | Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Kreider, PhD | Texas A&M University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise & Sport Nutrition Lab | College Station | Texas | 77843-4253 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39275314 | Derived | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | Participants will take placebo capsules during 3 months |
|
| From week 0 to week 12 |
| Change in attention and vigilance | Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS | From week 0 to week 4 |
| Change in executive function | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 12 |
| Change in executive function | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 4 |
| Change in episodic memory | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 12 |
| Change in episodic memory | Mean reaction time and accuracy in Stroop task module of the COMPASS | From week 0 to week 4 |
| Change in perceptual and cognitive skills | Mean reaction time and accuracy in Neurotracker light reaction test | From week 0 to week 4 |
| Change in perceptual and cognitive skills | Mean reaction time and accuracy in Neurotracker light reaction test | From week 0 to week 12 |
| Stress level | Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress) | From week 0 to week 4 |
| Stress level | Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress) | From week 0 to week 12 |
| Sleep quality | Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality) | From week 0 to week 12 |
| Sleep quality | Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality) | From week 0 to week 4 |
| Mood state | Change Bond-Lader Mood rating scale from 0 to 10 (low mood state) | From week 0 to week 4 |
| Mood state | Change Bond-Lader Mood rating scale from 0 to 10 (low mood state) | From week 0 to week 12 |
| Inflammation IL-6 | Change Interleukin-6 level (pg/ml) | from week 0 to week 12 |
| Inflammation IL-6 | Change Interleukin-6 level (pg/ml) | from week 0 to week 4 |