A study of the acute cognitive and neurocognitive effects of Panax Quinquefolius (American Ginseng) in middle aged volunteers.

Phase 3

Completed

• Conditions: Cognitive Function; Glucoregulatory Function; Alternative and Complementary Medicine - Other alternative and complementary medicine; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12610000849099
• Lead Sponsor: aturex

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-08
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Healthy non-smoking males and females aged between 40 and 60 years.
2. No history of anxiety, depression, psychiatric disorders confirmed using Depression Anxiety Stress Scale) or epilepsy
3. No history of / do not currently suffer from heart disease or high blood pressure or diabetes
4. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study
5. Not taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
6. No health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
7. Absence of pregnancy (confirmed using a pregnancy test)
8. Are willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
9. Are willing to provide small finger prick blood samples throughout the testing phases
10. Are not photosensitive (a sensitivity to visual stimuli, such as flashing lights, bright lights, light presented to full visual field, or static or moving patterns of light and dark stripes)
11. Absence of cognitive decline and a score > 24 on the mini mental state examination and within normal ranges on CDR battery
12. Understand the rating scales and computer tests (as judged by the study coordinator)
13. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial.
14. Have a fasting blood glucose <6.1mmol/l
15. Systolic blood pressure withing the normal range (91-139mmHg) and diastolic blood pressure within the normal range (61-89mmHg)

Exclusion Criteria

Smoker, hypersensitivity to investigational product, anxiety, depression, psychiatric disorder, epilepsy, heart disease, high blood pressure, diabetes, taking medications, health conditions that would effect food metabolism, pregnant/breast feeding, unable to commit to testing days, photo sensitive, not willing to provide finger prick blood samples, use of over the counter herbal supplements and dietary supplements 4 weeks prior to the study, history of head injury/stroke, alcoholism, clinically relevant abnormalities in medical history.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive functioning - measured using Cognitive Drug Research (CDR) battery and the Cognitive Demand Battery (CDB).[Baseline and 1, 3 and 6 hours Post-dose];Speed of information processing - measured by Steady State Topography (SST) latency.[6.5 hours post-dose]

Secondary Outcome Measures

Name	Time	Method
Mood measured using Bond-Lader Visual Analogue Scales, the State-Trait Anxiety Inventory (STAI) and the Profile of Mood States (POMS)[Baseline and 1, 3 and 6 hours post-dose]