Nutritional Supplement's Effects on Cognition

Study Overview
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Brief Summary
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This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.

Detailed Description
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The objective of this prospective, placebo controlled, double-blinded, parallel-group study is to examine the effects of dietary supplement containing grape juice extract, astaxanthin, and vitamin E over 12 week consumption on cognitive performance and self report results based on questionnaires. Furthermore, an evaluation of general well-being, mood, markers of oxidative stress, neurogenesis (BDNF), eye health, skin health, skin carotenoid concentrations, and safety measurements will be assessed.

Official Title
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An Examination Into the Effects of a Nutraceutical Supplement on Cognition, Stress, and Eye and Skin Health in Adults With Self-reported Cognitive Complaints: a Randomised, Double-blind, Placebo-controlled Trial

Conditions
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Healthy, Dietary Supplement, Cognition

Intervention / Treatment
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* Dietary Supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health Individuals Residing in independent living accommodations Subjective report of memory or attention problems by answering 'yes' to the following questions: Do you have problems with your memory, attention, or concentration? Non-smoker Body Mass Index (BMI) between 18-35 kg/m2 No plan to commence new treatments over the study period Understand, willing and able to comply with all study procedures Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the study Exclusion Criteria: Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer's Association (NIA/AA) criteria A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M) Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/malignancy Diagnosis of a psychiatric disease (other than mild-to moderate depression of anxiety) and/or neurological condition/disease (e.g. Parkinson's, Alzheimer's disease) History of paralysis, stroke or seizures or head injury (with loss of consciousness) Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibiters, or steroid medications. Taking vitamins or herbal supplements that are reasonably expected to influence study measures In the last 6 month, commenced or changed the dose of nutritional and/or herbal supplements that may impact on treatment outcome Alcohol intake greater than 14 standard drinks per week Current or 12-month history of illicit drug abuse Pregnant women, women who are Brest feeding, or women who intend to fall pregnant Any significant surgeries over the last year Planned major lifestyle change in the next 3 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Prospective, Double Blind, Placebo-Controlled design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Softgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E | Dietary Supplement: Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E<br>* 2 softgels per day<br>* Other names: Astaxanthin, Grape Juice Extract, All Natural Vitamin E;|
| Placebo Comparator: Placebo<br>Softgel containing: Olive Oil and Sunflower Lecithin | Dietary Supplement: Placebo<br>* 2 softgels per day<br>* Other names: Olive oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in working memory | Determine change in working memory as measured by the Numeric Working Memory Test | Baseline and Week 12 | 
| Change in Working memory by Corsi Block tasks | Determine if working memory change by doing Corsi blocks task | Baseline and Week 12 | 
| Change in verbal learning and memory | Determine if verbal learning and memory change using total score on Rey Auditory Verbal Learning test trials 1 to 5 | Baseline and Week 12 | 
| Change in episodic memory | Determine change in episodic memory as measured by Rey Auditory Verbal Learning Test delayed recall and computerized location learning task | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in accuracy of attention | Determine change inaccuracy of attention as measured by the choice reaction time and digit vigilance task (percent correct) | Baseline and Week 12 | 
| Change in the Everyday Memory | Determine the change in the Everyday Memory Questionnaire total score | Baseline, Week 4, Week 8, Week 12 | 
| Change in the Perceived Stress score | Determine the change in the Perceived Stress Questionnaire total score | Baseline, Week 4, Week 8, Week 12 | 
| Change in the World Health Organization score | Determine the change in the World Health Organization-5 (WHO-5) score | Baseline, Week 4, Week 8, Week 12 | 
| Change in oxidative stress marker | Determine change in plasma malondialdehyde | Baseline and Week 12 | 
| Change in plasma Tumor Necrosis Factor-alpha concentrations | Determine change in plasma Tumor Necrosis Factor concentrations | Baseline and Week 12 | 
| Change in marker of inflammation in the plasma | Determine the change in the plasma marker (interleukin-6-alpha concentrations | Baseline and Week 12 | 
| Change in plasma Brain-derived neurotropic factor concentrations | Determine the change in plasma Brain-derived neurotropic factor concentrations | Baseline and Week 12 | 
| Change in Skin Carotenoid Score | Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner) | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary Supplement, Cognition, Memory, Mental Stress, Wellbeing, Antioxidant, Astaxanthin, Grape Juice Extract