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Effects of a herbal supplement on cognition and social behaviour in healthy adults.

Neurocognitive effects of a multiherbal, polyphenol rich supplement for cognition and prosocial behaviour in healthy adults: a randomised controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001331921
Acronym
HrBI2
Enrollment
60
Registered
2020-12-10
Start date
2021-04-08
Completion date
2021-11-09
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Evidence from scientifc studies demonstrate positive effects of ingredients Ginseng (Cereboost), Bacopa and Coffee fruit extract as isolated components, on various mechanisms that impact cognitive performance and mood. For example, Ginseng and Gingko have been shown to enhance cognitive performance after acute dosing whilst Bacopa has been shown to have effects primarily with chronic dosing. To date however, the effect of these combined ingredients on cognition, behaviour and brain functioning as a result of chronic dosing has not been evaluated. The study involves a four-week supplementation period followed by a two-week washout period. Measures of cognitive performance, behaviour, and BDNF levels are undertaken at baseline (presupplementation), postsupplementation (week 4) and at the end of the washout period (week 6) to assess potential supplementation effects on cognitive performance and functioning. This research seeks to understand any changes in cognitive performance and brain activation patterns using standardized cognitive tasks and a non-invasive functional near infrared spectroscopy (fNIRS), measured both before and after taking the active or placebo supplement.

Interventions

A 6 week, double blinded, placebo-controlled between conditions (active and placebo supplementation) intervention, which includes 4 weeks of supplementation followed by 2-weeks washout. Participants consume a single, 2 tablet dose (500 mg) daily for 4 weeks of the either the active supplement (herbal combination of Bacopa 300mg, Ginseng 100mg and Coffee fruit extract 100mg) or placebo (microcrystalline cellulose 581mg), followed by 2 weeks (14 days ) of no supplement. Participants will complete

A 6 week, double blinded, placebo-controlled between conditions (active and placebo supplementation) intervention, which includes 4 weeks of supplementation followed by 2-weeks washout. Participants consume a single, 2 tablet dose (500 mg) daily for 4 weeks of the either the active supplement (herbal combination of Bacopa 300mg, Ginseng 100mg and Coffee fruit extract 100mg) or placebo (microcrystalline cellulose 581mg), followed by 2 weeks (14 days ) of no supplement. Participants will complete three testing points, pre intervention, post supplementation and post wash-out. Adherence will be measured through participant self report and by checking remaining supplement tablets at the post intervention testing session.

Sponsors

Central Queensland University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy adults aged 35- 65 years, without major medical conditions, such as diabetes, cardiovascular disease, acute or terminal illness; BMI below 35, moderate alcohol consumption, no medication changes for the management of health conditions within last 6 weeks, no current or recent history of taking medications for mood disorders and/or previous history of neurological conditions as these conditions have been shown to be related to impaired cognitive performance.

Exclusion criteria

Pre-existing medical conditions, including diabetes, cardiovascular disease, medication changes for the management of health conditions within last 6 weeks, current or recent history of taking medications for mood disorders and/or previous history of neurological conditions.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026