PHAEO-FOUR: Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo group 4 capsules per day containing 275mg of Maltodextrin |
Dietary Supplement: Placebo
Participants will take placebo capsules during 3 months
|
| Experimental: BrainPhyt High dose 4 capsules per day containing 275mg of BrainPhyt |
Dietary Supplement: Brainphyt high dose
Participants will take BrainPhyt capsules during 3 months
|
Outcome Measures
Primary Outcome Measures
- Change in spatial Working Memory [From week 0 to week 12]
Mean Span Score in Corsi Blocks module of the COMPASS
Secondary Outcome Measures
- Change in spatial working memory [From week 0 to week 4]
Mean Span Score in Corsi Blocks module of the COMPASS
- Change in attention and vigilance [From week 0 to week 12]
Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS
- Change in attention and vigilance [From week 0 to week 4]
Mean reaction time and accuracy in Digit Vigilance Task module of the COMPASS
- Change in executive function [From week 0 to week 12]
Mean reaction time and accuracy in Stroop task module of the COMPASS
- Change in executive function [From week 0 to week 4]
Mean reaction time and accuracy in Stroop task module of the COMPASS
- Change in episodic memory [From week 0 to week 12]
Mean reaction time and accuracy in Stroop task module of the COMPASS
- Change in episodic memory [From week 0 to week 4]
Mean reaction time and accuracy in Stroop task module of the COMPASS
- Change in perceptual and cognitive skills [From week 0 to week 4]
Mean reaction time and accuracy in Neurotracker light reaction test
- Change in perceptual and cognitive skills [From week 0 to week 12]
Mean reaction time and accuracy in Neurotracker light reaction test
- Stress level [From week 0 to week 4]
Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress)
- Stress level [From week 0 to week 12]
Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress)
- Sleep quality [From week 0 to week 12]
Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality)
- Sleep quality [From week 0 to week 4]
Change in Leeds Sleep Evaluation questionnaire from 0 to 10 (low sleep quality)
- Mood state [From week 0 to week 4]
Change Bond-Lader Mood rating scale from 0 to 10 (low mood state)
- Mood state [From week 0 to week 12]
Change Bond-Lader Mood rating scale from 0 to 10 (low mood state)
- Inflammation IL-6 [from week 0 to week 12]
Change Interleukin-6 level (pg/ml)
- Inflammation IL-6 [from week 0 to week 4]
Change Interleukin-6 level (pg/ml)
Eligibility Criteria
Criteria
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.
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Body-mass index between 18.5 and 35.0 kg/m2
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Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
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Have age-associated memory impairment (AAMI) based on the following National Institute of Mental Health criteria, specified as scoring:
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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
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A score on the MAC-Q of ≥25.
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Is in general good health, as determined by the investigator
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Ability to comply and understand the cognitive function practice tests
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Willing to maintain their habitual diet and exercise routines.
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Willing to maintain consistent sleep duration the evening before study visits.
Exclusion Criteria:
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Use of medications or supplements known to alter cognitive function within past 2 weeks
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Abnormal clinical laboratory test that may affect study outcome.
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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
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History or presence of cancer, except nonmelanoma skin cancer
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Uncontrolled hypertension/diabetes
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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.
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History within previous 12 months of alcohol or substance abuse.
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History of heavy smoking (>1 pack/day) within past 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Exercise & Sport Nutrition Lab | College Station | Texas | United States | 77843-4253 |
Sponsors and Collaborators
- Microphyt
- Texas A&M University
Investigators
- Principal Investigator: Richard Kreider, PhD, Texas A&M University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB2021-1360F