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| Name | Class |
|---|---|
| Naturex | OTHER |
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Ginseng refers to the extract of any slow growing perennial plant with a fleshy root, deriving from the Panax genus of the Araliaceae family. Ginseng root has been used as an intervention for the treatment of diabetes (Sotaniemi, Haapakoski & Rautio, 1995), boosting cognitive function (Scholey et al., 2010) and improving mental health (Ellis & Reddy, 2002). The most commonly used ginseng is Panax ginseng (Asia) and Panax quinquefolius (America). Ginsensosides are considered the core phytochemical compounds that contribute to the alleged beneficial effects of ginseng. In particular, ginsenosides Rb1 and Rg1 have been isolated and investigated for effects on cognitive function (Shin et al., 2016).
Scholey et al. (2010) was one of the first studies to provide support for a beneficial cognitive effect from American ginseng (Cereboostâ„¢), with better performance on working memory in healthy young adults. Improvements were most profound for a single dose of 200 mg on working memory tasks, specifically immediate word recall and numeric working memory speed. Cereboost also increased self-rated calmness compared to placebo, suggesting ginseng can enhance aspects of mood. Similarly, Ossoukhova et al. (2015) compared a single 200mg dose to placebo to investigate whether beneficial cognitive effects extend to a middle-aged cohort. Here, Cereboost significantly improved performance on the Cognitive Drug Research (CDR) working memory factor, specifically improving spatial working memory at three hours post dose.
Further study is required to evaluate ginseng specific effects with a standardized extract of P. quinquefolius, such as Cereboostâ„¢ on healthy participants. Significant results will have implications for investigating the neurocognitive effects in other populations, such as those with cognitive and memory problems.
The study comprises of a familiarisation visit and then two test days. The test days are separated by a 2 week interval during which time participants will be asked to consume a daily capsule for 14 days which will contain either an American ginseng root extract (200 mg Cereboost and Maltodextrin) or an identical placebo that does not contain any of the active ingredient. Participants will be asked to restrict their intake of certain foods for 48 hours before test days and intake of alcohol and caffeinated drinks for 24 hours prior. All participants will be required to fast overnight prior to each of the study days. Participants may withdraw at any time without giving any reason. In addition, a participant will be withdrawn from the study if they request discontinuation, exhibit a serious adverse event to any component of the test product, the participant significantly violates the exclusion or inclusion criteria, an illness emerges and/or opinion is that withdrawal is appropriate.
An outline of each session is as follows:
The computerized cognitive battery will include tests which are known to be sensitive to nutritional manipulations (Lamport, 2012) and will last no more than 45 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| American ginseng | Experimental | 200mg Cereboost and Maltodextrin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cereboost | Dietary Supplement | 200mg Cereboost and Maltodextrin capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rapid Visual Information Processing task | This task will assess attention processes. In this task a series of digits are presented one at a time on the screen, in quick succession at a rate of 100/min. The participant must examine the continuous series for a sequence of three consecutive even or three consecutive odd digits. The participant must respond once they have detected a sequence string by pressing the space bar as quickly as possible. Up to 8 correct target strings will be presented in each minute, and the task will last approximately 6 minutes. The task will be scored for accuracy. | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate word recall | Using the methodology outlined in Scholey et al., (2010), participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to type as many of these words as possible, with the resulting score recorded as a percentage of accuracy. | 14 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Psychology and Clinical Languages | Reading | RG2 9JR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8721940 | Background | Sotaniemi EA, Haapakoski E, Rautio A. Ginseng therapy in non-insulin-dependent diabetic patients. Diabetes Care. 1995 Oct;18(10):1373-5. doi: 10.2337/diacare.18.10.1373. | |
| 20676609 | Background | Scholey A, Ossoukhova A, Owen L, Ibarra A, Pipingas A, He K, Roller M, Stough C. Effects of American ginseng (Panax quinquefolius) on neurocognitive function: an acute, randomised, double-blind, placebo-controlled, crossover study. Psychopharmacology (Berl). 2010 Oct;212(3):345-56. doi: 10.1007/s00213-010-1964-y. Epub 2010 Jul 31. |
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| ID | Term |
|---|---|
| C000615592 | Cereboost |
| C000713447 | Asian ginseng |
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Between and within groups model
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Double-blind
| Placebo | Dietary Supplement | 200mg Maltodextrin capsules |
|
| Corsi blocks task |
This task examines visuospatial memory. Nine identical squares are fixed in a random arrangement on a screen. Participants observe spatial sequences of between two and nine blocks. Four versions of each sequence length presented during the task. The task is to reproduce the sequence, immediately after each presentation by pressing the relevant squares on the screen. The dependent variable is the number of blocks pointed out in the correct order. A novel sequence will be presented on each occasion, the order of which will be counterbalanced across participants. |
| 14 Days |
| Modified Attention Network Task | This task examines execution function, attention and inhibition. In this task, participants have to respond to a centrally presented arrow, pointing to the left or the right by pressing the corresponding key on the keyboard. The central arrow is flanked by arrows that point in the same (congruent) or opposite (incongruent) direction. In order to perform the task effectively, participants have to ignore the flanking arrows. Previous studies have found that participants show larger latencies and more errors on incongruent trials when compared with congruent trials due to the conflicting interference of the incongruently facing arrows. The response latencies to congruent trials reflect processing speed, while the amount of interference during incongruent trials indicates susceptibility to interference. | 14 Days |
| Task Switch Task | This task measures executive function and attention. Participants view a circle with 8 equally spaced radii 2 of which form a bold bisecting line. Numbers are chosen randomly from a set of 1-4 & 6-9 and displayed sequentially in a clockwise direction. A response of higher or lower than 5 is made for trials below the bold line, and even or odd for numbers above the line. General measures of accuracy and response time along with specific measures of switching cost for the first trial after each task change are acquired. | 14 Days |
| Delayed word recall | Approximately 35 minutes after the immediate word recall task, participants will be allowed 60seconds to write down as many items they can remember from the immediate word recall test. | 14 Days |
| Mood | The Positive and Negative Affect Scale (PANAS - N) will be used to examine mood states at the start and end of the cognitive task battery. It is regarded as a reliable measure for non-clinical populations (Crawford et al, 2004). Participants are asked to rate the extent to which they experienced each out of 20 emotions on a 5-point Likert scale ranging from "very slightly" to "very much". Half of the presented emotion words concern negative affect (distressed, upset, guilty, ashamed, hostile, irritable, nervous, jittery, scared, afraid), the other half positive affect (interested, alert, attentive, excited, enthusiastic, inspired, proud, determined, strong, active). Additionally, the PANAS - X will be used to measure trait mood. | 14 Days |
| 11895046 | Background | Ellis JM, Reddy P. Effects of Panax ginseng on quality of life. Ann Pharmacother. 2002 Mar;36(3):375-9. doi: 10.1345/aph.1A245. |
| 27112419 | Background | Shin K, Guo H, Cha Y, Ban YH, Seo da W, Choi Y, Kim TS, Lee SP, Kim JC, Choi EK, Yon JM, Kim YB. Cereboost, an American ginseng extract, improves cognitive function via up-regulation of choline acetyltransferase expression and neuroprotection. Regul Toxicol Pharmacol. 2016 Jul;78:53-8. doi: 10.1016/j.yrtph.2016.04.006. Epub 2016 Apr 22. |
| 25778987 | Background | Ossoukhova A, Owen L, Savage K, Meyer M, Ibarra A, Roller M, Pipingas A, Wesnes K, Scholey A. Improved working memory performance following administration of a single dose of American ginseng (Panax quinquefolius L.) to healthy middle-age adults. Hum Psychopharmacol. 2015 Mar;30(2):108-22. doi: 10.1002/hup.2463. |
| 34396468 | Derived | Bell L, Whyte A, Duysburgh C, Marzorati M, Van den Abbeele P, Le Cozannet R, Fanca-Berthon P, Fromentin E, Williams C. A randomized, placebo-controlled trial investigating the acute and chronic benefits of American Ginseng (Cereboost(R)) on mood and cognition in healthy young adults, including in vitro investigation of gut microbiota changes as a possible mechanism of action. Eur J Nutr. 2022 Feb;61(1):413-428. doi: 10.1007/s00394-021-02654-5. Epub 2021 Aug 15. |