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| Name | Class |
|---|---|
| Abbott Nutrition | INDUSTRY |
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The purpose of this study is to study effects of a four months lutein supplementation (in form of a lutein fortified nutritional beverage) on general learning and memory performance as well as on acute stress-induced changes in learning and memory performance in chronically stressed males and females using 2 different lutein doses in comparison to a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional beverage fortified with 6mg lutein/day | Experimental |
| |
| Nutritional beverage fortified with 12mg lutein/day | Experimental |
| |
| Nutritional beverage fortified with 0mg lutein/day | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional beverage fortified with 6mg lutein/day | Dietary Supplement | 2 beverages (each containing 3mg lutein) per day (total of 6mg lutein/day) for a total of 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Memory (Paired Associates Learning (PAL / CANTAB)) | Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total error adjusted) from baseline measurement to 2 months | Day 0 (baseline) - day 57 |
| Visual Memory (Paired Associates Learning (PAL / CANTAB)) | Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total error adjusted) from baseline measurement to 4 months | Day 0 (baseline) - day 113 |
| Visual Memory (Verbal Recognition Memory (VRM /CANTAB)) | Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total number of words correct on immediate recall (the sum of the two free recall trials immediately after each presentation) and delayed recall (the number of correctly recalled words after a delay of approximately 30 min)) from baseline measurement to 2 months | Day 0 (baseline) - day 57 |
| Visual Memory (Verbal Recognition Memory (VRM /CANTAB)) | Visual Memory Task on a computer. Outcome measurements: Change of accuracy (total number of words correct on immediate recall (the sum of the two free recall trials immediately after each presentation) and delayed recall (the number of correctly recalled words after a delay of approximately 30 min)) from baseline measurement to 4 months | Day 0 (baseline) - day 113 |
| Executive Function (Spatial Working Memory (SWM / CANTAB)) | Executive Memory Task on a computer. Outcome measurements: Change of accuracy (the total number of between search errors at 4-, 6- and 8-box stages and the strategy score) from baseline measurement to 2 months | Day 0 (baseline) - day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Memory after TSST (Paired Associates Learning (PAL / CANTAB)) | Visual Memory PAL will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy (total error adjusted) from before to after TSST. | Day 113 |
| Visual Memory after TSST (Verbal Recognition Memory (VRM /CANTAB)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Clemens, MD | DAaCRO GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DAaCRO GmbH | Trier | Trier | D-54296 | Germany |
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| Nutritional beverage fortified with 12mg lutein/day | Dietary Supplement | 2 beverages (each containing 6mg lutein) per day (total 12mg lutein/day) for a total of 4 months |
|
| Nutritional beverage fortified with 12mg lutein/day | Dietary Supplement | 2 beverages (each containing 0mg lutein) per day (total 0mg lutein/day) for a total of 4 months |
|
| Executive Function (Spatial Working Memory (SWM / CANTAB)) |
Executive Memory Task on a computer. Outcome measurements: Change of accuracy (the total number of between search errors at 4-, 6- and 8-box stages and the strategy score) from baseline measurement to 4 months |
| Day 0 (baseline) - day 113 |
| Executive Function (Spatial Span (SSP / CANTAB)) | Executive Memory Task on a computer. Outcome measurements: Change of accuracy (Span length forwards) from baseline measurement to 2 months | Day 0 (baseline) - day 57 |
| Executive Function (Spatial Span (SSP / CANTAB)) | Executive Memory Task on a computer. Outcome measurements: Change of accuracy (Span length forwards) from baseline measurement to 4 months | Day 0 (baseline) - day 113 |
| Attention and Concentration (Reaction Time (RTI / CANTAB)) | Attention and Concentration Task on a computer. Outcome measurements: Change of reaction time from baseline measurement to 2 months | Day 0 (baseline) - day 57 |
| Attention and Concentration (Reaction Time (RTI / CANTAB)) | Attention and Concentration Task on a computer. Outcome measurements: Change of reaction time from baseline measurement to 4 months | Day 0 (baseline) - day 113 |
| Attention and Concentration (Rapid Visual Information Processing (RVP / CANTAB)) | Attention and Concentration Task on a computer. Outcome measurements: Change of target sensitivity and response latency from baseline measurement to 2 months | Day 0 (baseline) - day 57 |
| Attention and Concentration (Rapid Visual Information Processing (RVP / CANTAB)) | Attention and Concentration Task on a computer. Outcome measurements: Change of target sensitivity and response latency from baseline measurement to 4 months | Day 0 (baseline) - day 113 |
| Verbal Fluency: Regensburg Verbal Fluency Test (RWT) | Verbal Fluency Task on a computer. Outcome measurements: Change of accuracy (amount of correct answers, breaches of rules, repetitions and total errors) from baseline measurement to 2 months | Day 0 (baseline) - day 57 |
| Verbal Fluency: Regensburg Verbal Fluency Test (RWT) | Verbal Fluency Task on a computer. Outcome measurements: Change of accuracy (amount of correct answers, breaches of rules, repetitions and total errors) from baseline measurement to 4 months | Day 0 (baseline) - day 113 |
Visual Memory VRM will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy from before to after TSST. |
| Day 113 |
| Executive Function after TSST (Spatial Working Memory (SWM / CANTAB)) | Executive Function SWM will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy from before to after TSST. | Day 113 |
| Executive Function after TSST (Spatial Span (SSP / CANTAB)) | Executive Function SSP will be tested before and after an acute social stress test (Trier Social Stress Test (TSST)). Outcome measure: Difference in accuracy from before to after TSST. | Day 113 |
| Mood (Visual Analog Scale (VAS)) | Mood will be assessed by VAS. Outcome variables on: alertness, calmness and contentment. Changes of these parameters from baseline day to day 57 and from before to after cognitive test batteries on test days as described above. | Day 0 (baseline) to day 57 |
| Mood (Visual Analog Scale (VAS)) | Mood will be assessed by VAS. Outcome variables on: alertness, calmness and contentment. Changes of these parameters from baseline day to day 113 and from before to after cognitive test batteries on test days as described above. | Day 0 (baseline) to day 113 |
| Stress (Perceived Stress Scale (PSS)) | Changes on stress levels will be assessed by PSS. Outcome variables: changes of how unpredictable, uncontrollable, and overloaded subjects perceive their lives. | Day 0 (baseline) to day 57 |
| Stress (Perceived Stress Scale (PSS)) | Changes on stress levels will be assessed by PSS. Outcome variables: changes of how unpredictable, uncontrollable, and overloaded subjects perceive their lives. | Day 0 (baseline) to day 113 |
| Anxiety (State-Trait-Anxiety Inventory (STAI)) | Changes on personal sensed anxiety levels will be assessed by the STAI questionnaire. Outcome variables: changes of state or trait anxiety scale from before TSST to after the TSST on day 113. | Day 113 |
| Erythrocyte and serum lutein levels | Changes in erythrocyte and serum lutein levels will be assessed between baseline and day 113. | Day 0 (baseline) to day 113 |