Age-associated Memory Impairment
Conditions
Keywords
Elderly, Microalgae, Cognitive function, inflammation
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.
Interventions
DIETARY_SUPPLEMENTBrainphyt high dose
Participants will take BrainPhyt capsules during 3 months
DIETARY_SUPPLEMENTPlacebo
Participants will take placebo capsules during 3 months
Sponsors
Texas A&M University
Microphyt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 55 Years
Healthy volunteers
Yes
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: 1. Absence of dementia as determined by a score of \>24 on the Mini Mental State Examination (MMSE). 2. ≤29 or ≤9 on the VPA I and II portions of the Wechsler Memory Scale IV, respectively 3. 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spatial Working Memory | From week 0 to week 12 | Mean Span Score in Corsi Blocks module of the COMPASS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 executive function | 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 12 | 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 spatial working memory | From week 0 to week 4 | Mean Span Score in Corsi Blocks module of the COMPASS |
| Sleep quality | From week 0 to week 12 | 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) |
| Inflammation IL-6 | from week 0 to week 12 | Change Interleukin-6 level (pg/ml) |
| Stress level | From week 0 to week 4 | Change in Cohen's Perceived Stress Scale from 0 to 40 (high stress) |
Countries
United States
Outcome results
None listed