Cognition, Dietary Supplement, Healthy
Conditions
Keywords
Dietary Supplement, Cognition, Memory, Mental Stress, Wellbeing, Antioxidant, Astaxanthin, Grape Juice Extract
Brief summary
This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSoftgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E
2 softgels per day
DIETARY_SUPPLEMENTPlacebo
2 softgels per day
Sponsors
Clinical Research Australia
Pharmanex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Softgels with similar appearance
Intervention model description
Randomized, Prospective, Double Blind, Placebo-Controlled design
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in verbal learning and memory | Baseline and Week 12 | Determine if verbal learning and memory change using total score on Rey Auditory Verbal Learning test trials 1 to 5 |
| Change in episodic memory | Baseline and Week 12 | Determine change in episodic memory as measured by Rey Auditory Verbal Learning Test delayed recall and computerized location learning task |
| Change in Working memory by Corsi Block tasks | Baseline and Week 12 | Determine if working memory change by doing Corsi blocks task |
| Change in working memory | Baseline and Week 12 | Determine change in working memory as measured by the Numeric Working Memory Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the World Health Organization score | Baseline, Week 4, Week 8, Week 12 | Determine the change in the World Health Organization-5 (WHO-5) score |
| Change in oxidative stress marker | Baseline and Week 12 | Determine change in plasma malondialdehyde |
| Change in marker of inflammation in the plasma | Baseline and Week 12 | Determine the change in the plasma marker (interleukin-6-alpha concentrations |
| Change in plasma Brain-derived neurotropic factor concentrations | Baseline and Week 12 | Determine the change in plasma Brain-derived neurotropic factor concentrations |
| Change in Skin Carotenoid Score | Baseline and Week 12 | Determine the change in Skin Carotenoid Scores using Raman spectroscopy (BioPhotonic Scanner) |
| Change in plasma Tumor Necrosis Factor-alpha concentrations | Baseline and Week 12 | Determine change in plasma Tumor Necrosis Factor concentrations |
| Change in accuracy of attention | Baseline and Week 12 | Determine change inaccuracy of attention as measured by the choice reaction time and digit vigilance task (percent correct) |
| Change in the Everyday Memory | Baseline, Week 4, Week 8, Week 12 | Determine the change in the Everyday Memory Questionnaire total score |
| Change in the Perceived Stress score | Baseline, Week 4, Week 8, Week 12 | Determine the change in the Perceived Stress Questionnaire total score |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Surface Disease Index score | Baseline, Week 4, Week 8, Week 12 | Determine the change in Ocular Surface Disease Index score |
| Change in systolic blood pressure measurement (safety measure) | Baseline and Week 12 | Determine change in systolic blood pressure measurement using sphygmomanometer |
| Change in diastolic blood pressure measurement (safety measure) | Baseline and Week 12 | Determine change in diastolic blood pressure changes using sphygmomanometer |
Countries
Australia
Contacts
Primary ContactAdrian Lopresti, MD
Backup ContactStephen Smith
Outcome results
None listed