Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt High Dose on Cognitive Function in Healthy Older Individuals

Conditions
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Age-associated Memory Impairment

Intervention / Treatment
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* Dietary Supplement: Brainphyt high dose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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: Absence of dementia as determined by a score of >24 on the Mini Mental State Examination (MMSE). ≤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. 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>4 capsules per day containing 275mg of Maltodextrin | Dietary Supplement: Placebo<br>* Participants will take placebo capsules during 3 months<br>|
| Experimental: BrainPhyt High dose<br>4 capsules per day containing 275mg of BrainPhyt | Dietary Supplement: Brainphyt high dose<br>* Participants will take BrainPhyt capsules during 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Microalgae, Cognitive function, inflammation