Cereboost (American Ginseng Extract) and Brain Function

NCT ID: NCT07255755

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-01-31

Brief Summary

The study will assess the immediate, short-term benefits of a single dose of a supplement containing 200mg of Panax quinquefolius (American Ginseng) on cognition (brain function) in healthy young adults.

To understand the effect this product may have, the participants will complete a series of questionnaires and cognitive tests (tests of memory and brain function) at set intervals across a 6-hour period. Blood samples will also be collected to assess the impact of the study product on the participants.

Detailed Description

Lifestyle strategies such as nutritional interventions have received increased attention as they provide safe and effective solutions to improve cognitive performance. Ginseng, a popular herbal root extract obtained from plants of the Panax family, is widely regarded as a panacea in traditional medicine and has been used for centuries to treat mental and physical ailments and promote longevity. Ginseng contains a number of bioactives including flavonoids and other phenolic compounds, essential oils, and vitamins. However, the main bioactive ingredients in ginseng are purported to be ginsenosides including Rb1, Re, Rd, and F11. Among multiple species of ginseng, American ginseng (Panax quinquefolius) provides a particularly rich source of these ginsenoside when compared to other ginseng varieties, and emerging research suggests that supplementation with Panax quinquefolius may elicit cognitive enhancement effects.

Cereboost TM from Givaudan SA is a standardised extract of American ginseng and has been reported to exert such benefits. For example, following acute supplementation with 100 mg, 200 mg and 400 mg Cereboost TM, improvements on an immediate word recall task, a visuospatial working memory task, a choice reaction time task, a composite working memory factor, and a measure of subjective mood (i.e. calmness) were observed in healthy young adults (aged 18-40 years) during the six hours after consumption. Adding to these findings, a study of middle-aged adults (aged 40-60 years) observed similar acute benefits of 200 mg Cereboost TM on a composite working memory factor after three hours, although no changes in mood were observed in this older age group. More recently, improved working memory and attention during the immediate postprandial period (2-6 hours) in healthy young adults was reported following Cereboost TM 200mg intake.

We are interested in conducting a larger study (n=200) employing standardised methods to investigate the acute benefits of a single dose (200mg) of American ginseng (Cereboost TM) and focusing mainly on the Modified Attention Network Task (MANT) test as the primary outcome.

Conditions

Attention; Cognition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

A placebo capsule (containing maltodextrin)

Group Type: PLACEBO_COMPARATOR

Placebo product

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsules, identical in appearance to active treatment, but only containing maltodextrin

Study Product

Study product capsule containing 200mg American Ginseng extract (Cereboost TM)

Group Type: EXPERIMENTAL

American Ginseng extract

Intervention Type: DIETARY_SUPPLEMENT

Cereboost TM capsules delivering 200 mg of Panax quinquefolius extract standardised for ginsenosides (10-12%)

Interventions

American Ginseng extract

Cereboost TM capsules delivering 200 mg of Panax quinquefolius extract standardised for ginsenosides (10-12%)

Intervention Type: DIETARY_SUPPLEMENT

Placebo product

Placebo capsules, identical in appearance to active treatment, but only containing maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

To be eligible for inclusion, the Participant must fulfil all the following criteria:

1. Be able to give written informed consent.

2. Be between 18-40 years, inclusive.

3. Depression Anxiety and Stress Scale scores (DASS-21):

1. Depression ≤9

2. Anxiety ≤7

3. Stress ≤14

4. Willing to refrain from alcohol consumption 24-hours prior to assessment visits.

5. Willing to refrain from caffeine consumption (including but not limited to energy drinks, soda, coffee…) on the morning of the assessment visit.

6. Non-smokers and non-vapers

7. Willing to consume the Study Product (SP).

8. Willing to attend the study visit in an overnight fasted state, having followed a low-polyphenol diet for 48 h.

9. Fluent in written and spoken English

Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.

2. Has food allergies or other issues with foods that would preclude intake of the Study Products.

3. Not willing to consume gelatine from bovine/porcine source

4. Has a BMI ≤18.5 or ≥30kg/m2

5. Blood pressure >140/90 mmHg

6. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.

7. Excluded health conditions include:

1. Cognitive disorders in the past 12 months.

2. Current or past history of a major neuropsychiatric disorder, including: bipolar disorder, schizophrenia and schizotypal personality disorder

3. Current or past history of a major neurological condition.

4. Gastrointestinal disorders (e.g. IBS/IBD)

5. ADHD (attention deficit hyperactivity disorder)

6. Learning disabilities and difficulties

7. Current, uncorrected, vision or hearing impairment

8. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:

1. Anti-psychotics

2. Anti-coagulants (including Warfarin)

3. Anti-platelets (including Aspirin and Clopidogrel)

4. Sedatives

5. Monoamine Oxidase Inhibitors (MAOIs)

9. Taking any dietary supplements and unwilling to stop for two weeks prior to and for the duration of participation in the study

10. Current or history of drug or alcohol abuse

11. Current or history of: HIV, kidney disease, liver or biliary disorders, cancer, cardiovascular disease, pulmonary disease (chronic respiratory trouble)

12. Planned surgery within 2 weeks of their participation in the study

13. Do not agree to the GP being contacted about participation and screening results

14. Participated in any other cognitive trials within the last month

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Givaudan France Naturals

INDUSTRY

Sponsor Role: collaborator

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Vauzour, PhD

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Locations

Quadram Insitute Clinical Research Facility

Norwich, Norfolk, United Kingdom

Site Status: RECRUITING

University of East Anglia

Norwich, Norfolk, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

David Vauzour, PhD

Role: CONTACT

D.Vauzour@uea.ac.uk

+441603591732

Other Identifiers

IRAS355890

Identifier Type: OTHER

Identifier Source: secondary_id

R211952

Identifier Type: -

Identifier Source: org_study_id