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| Name | Class |
|---|---|
| Clinical Research Australia | OTHER |
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This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Softgel containing: Astaxanthin, Grape Juice Extract, and All Natural Vitamin E |
|
| Placebo | Placebo Comparator | Softgel containing: Olive Oil and Sunflower Lecithin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Softgel Cognitive Formulation containing Astaxanthin, Grape Juice Extract and All Natural Vitamin E | Dietary Supplement | 2 softgels per day |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Surface Disease Index score | Determine the change in Ocular Surface Disease Index score | Baseline, Week 4, Week 8, Week 12 |
| Change in diastolic blood pressure measurement (safety measure) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adrian Lopresti, MD | Contact | 61-8-9448-7376 | adrian@clinicalresearch.com.au | |
| Stephen Smith | Contact | 61-8-9448-7376 | stephen@clinicalresearch.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Adrian Lopresti, MD | Clinical Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Australia | Recruiting | Duncraig | Western Austrailia | 6023 | Australia |
No plan to share individual participant data. Will only report summary data i.e. means by responses to specific variables.
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C005948 | astaxanthine |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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Randomized, Prospective, Double Blind, Placebo-Controlled design
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Softgels with similar appearance
| Placebo | Dietary Supplement | 2 softgels per day |
|
|
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 |
Determine change in diastolic blood pressure changes using sphygmomanometer
| Baseline and Week 12 |
| Change in systolic blood pressure measurement (safety measure) | Determine change in systolic blood pressure measurement using sphygmomanometer | Baseline and Week 12 |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |