Investigating the Acute and Chronic Effects of an American Ginseng Root Extract on Cognition and Mood

NCT03579095 | Completed

• 1 other identifier: RDG-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cognitive Change; Effects of Ginseng on Cognitive Function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Immediate word recall

  14 Days

• Corsi blocks task

  14 Days

• Modified Attention Network Task

  14 Days

• Task Switch Task

  14 Days

• Delayed word recall

  14 Days

Study Arms (2)

American ginseng

EXPERIMENTAL

200mg Cereboost and Maltodextrin

Dietary Supplement: Cereboost

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Cereboost DIETARY_SUPPLEMENT

200mg Cereboost and Maltodextrin capsules

Also known as: American ginseng

American ginseng

Placebo DIETARY_SUPPLEMENT

200mg Maltodextrin capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy, between 18-30

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: lead
• Naturex: collaborator

Study Sites (1)

School of Psychology and Clinical Languages

Reading, RG2 9JR, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 8721940 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.

  PMID: 20676609 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.

  PMID: 11895046 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.

  PMID: 27112419 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.

  PMID: 25778987 BACKGROUND

• 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.

  PMID: 34396468 DERIVED

MeSH Terms

Interventions

Cereboost; Asian ginseng

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Neuroscience

Model Details: Between and within groups model

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: May 4, 2018
• Primary Completion: August 1, 2018
• Study Completion: June 1, 2019
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)