Cognitive ChangeNCT03579095
Investigating the Acute and Chronic Effects of an American Ginseng Root Extract on Cognition and Mood
A study testing Cereboost in people with Cognitive Change and Effects of Ginseng on Cognitive Function, run by University of Reading at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Effects of Ginseng on Cognitive Function
- What is being tested?
- Cereboost
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, between 18-30
Who cannot join
- Smoke
- Use medications that may affect the outcome
- Have any allergic reactions to ingredients in the capsules
- Have a BMI greater than or equal to 30
- Are vegetarian
- Taking any dietary supplements which they are unwilling to stop for the duration of the study
- Drink more than 2 alcoholic beverages per day on an average week
- Have participated in any other cognitive trials within the last month.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Psychology and Clinical Languages
Reading, RG2 9JR
About this study
Official title: Investigating the Acute and Chronic Effects of an American Ginseng Root Extract on Cognition and Mood.
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 (Cereboost™), 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 Cereboost™ on healthy participants. Significant results will have implications for investigating the neurocognitive effects in other populations, such as those with cognitive and memory problems.
Read the detailed description
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:
- Familiarisation/practice visit: Volunteers will attend the Nutritional Psychology unit at the University of Reading, where they will receive a detailed explanation on the study and will be asked to sign the informed consent form. Once consent has been given the inclusion/exclusion criteria will be checked and measures of age, height and weight will be taken. Participants will then be asked to fill out a food frequency questionnaire before completing training on the cognitive test battery. Participants will be given two food diaries, with each diary completed in the 48 hours before each test day to check habitual diet and ensure they followed low flavonoid protocol. Finally the PANAS - X will be administered to gain a measure of trait mood
- Test visits: On arrival of their first test day, participants will be randomly assigned to treatment (200 mg Cereboost™) or placebo condition. Each study day will begin at 9am with breakfast before completion of the computerized test battery to establish baseline performance. Participants will then take their allocated intervention and will be tested on the cognitive and mood battery at 2, 4 and 6 hours after consumption. A standard light lunch will be provided between the 2hr and 4 hr test points. On test visit 2, participants will have completed a 14 day course of their intervention and will be tested at the same time points at test visit 1, again receiving the intervention directly after the baseline test battery. Finally the PANAS - X will be administered again to gain a measure of trait mood following the 2 week intervention.
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.
- Being tested
- Cereboost, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CereboostDietary supplement
Also called American ginseng
200mg Cereboost and Maltodextrin capsules
PlaceboDietary supplement
200mg Maltodextrin capsules
| Study group | Role | What they receive |
|---|---|---|
| American ginseng | Experimental | 200mg Cereboost and Maltodextrin Receives: Dietary Supplement: Cereboost |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 Days
Secondary outcomes (6)
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.
Measured: 14 Days
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start4 May 2018
- Primary completion1 Aug 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between and within groups model
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex
- Responsible party
- Principal investigator, Prof Claire Williams, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579095
- Sponsor's protocol ID
- RDG-004
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2018
- Last updated
- 1 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8721940Scholey 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.
PubMed 20676609Ellis JM, Reddy P. Effects of Panax ginseng on quality of life. Ann Pharmacother. 2002 Mar;36(3):375-9. doi: 10.1345/aph.1A245.
PubMed 11895046Shin 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.
PubMed 27112419Ossoukhova 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.
PubMed 25778987Bell 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.
PubMed 34396468
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Acute and Chronic Effects of an American Ginseng Root Extract on Cognition and Mood.
- ClinicalTrials.gov ID
- NCT03579095
- Acronym / sponsor ID
- RDG-004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Naturex
- Study start
- 4 May 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (Cereboost™), 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 Cereboost™ on healthy participants. Significant results will have implications for investigating the neurocognitive effects in other populations, such as those with cognitive and memory problems.
Detailed description
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:
- Familiarisation/practice visit: Volunteers will attend the Nutritional Psychology unit at the University of Reading, where they will receive a detailed explanation on the study and will be asked to sign the informed consent form. Once consent has been given the inclusion/exclusion criteria will be checked and measures of age, height and weight will be taken. Participants will then be asked to fill out a food frequency questionnaire before completing training on the cognitive test battery. Participants will be given two food diaries, with each diary completed in the 48 hours before each test day to check habitual diet and ensure they followed low flavonoid protocol. Finally the PANAS - X will be administered to gain a measure of trait mood
- Test visits: On arrival of their first test day, participants will be randomly assigned to treatment (200 mg Cereboost™) or placebo condition. Each study day will begin at 9am with breakfast before completion of the computerized test battery to establish baseline performance. Participants will then take their allocated intervention and will be tested on the cognitive and mood battery at 2, 4 and 6 hours after consumption. A standard light lunch will be provided between the 2hr and 4 hr test points. On test visit 2, participants will have completed a 14 day course of their intervention and will be tested at the same time points at test visit 1, again receiving the intervention directly after the baseline test battery. Finally the PANAS - X will be administered again to gain a measure of trait mood following the 2 week intervention.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Between and within groups model
| Arm | Type | Receives |
|---|---|---|
| American ginseng | Experimental | Dietary Supplement: Cereboost200mg Cereboost and Maltodextrin |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, between 18-30
Key exclusion criteria (8 listed)
- Smoke
- Use medications that may affect the outcome
- Have any allergic reactions to ingredients in the capsules
- Have a BMI greater than or equal to 30
- Are vegetarian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CereboostAlso: American ginseng200mg Cereboost and Maltodextrin capsules | Dietary supplement | American ginseng |
| Placebo200mg Maltodextrin capsules | Dietary supplement | Placebo |
Primary outcome
Rapid Visual Information Processing task
Time frame: 14 Days
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.
6 secondary outcomes
Immediate word recall
Time frame: 14 Days
Corsi blocks task
Time frame: 14 Days
Modified Attention Network Task
Time frame: 14 Days
Task Switch Task
Time frame: 14 Days
Delayed word recall
Time frame: 14 Days
Mood
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Background: PubMed 8721940Sotaniemi 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.
- Background: PubMed 20676609Scholey 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.
- Background: PubMed 11895046Ellis JM, Reddy P. Effects of Panax ginseng on quality of life. Ann Pharmacother. 2002 Mar;36(3):375-9. doi: 10.1345/aph.1A245.
- Background: PubMed 27112419Shin 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.
- Background: PubMed 25778987Ossoukhova 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.
- Derived from this study: PubMed 34396468Bell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereboost in people with Cognitive Change and Effects of Ginseng on Cognitive Function, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Visual Information Processing task (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579095, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.