None listed
Conditions
Brief summary
The objective of the study is to determine the acute neurocognitive effects of a dose of Panax quinquefolius in healthy middle aged volunteers. The Cognitive Drug Research (CDR) computerized assessment battery will be used to evaluate effects of Ginseng on attention, working memory and secondary memory. Mood will also be assessed. Several paper and pencil questionnaires will also be completed which are designed to evaluate state and trait feelings of anxiety and depression and also to asses any symptomatology associated with the extract. Furthermore the neurophysiological effects will be measured using high spatial resolution electrical brain recordings measured by the Steady State Probe Topography technique (SSPT)
Interventions
Single dose of 200mg Panax Quinquefolius ( 11.65% saponin content; Rb1 (5.68%), Re (2.05%), Rc (1.86%), Rd (1.47%), Rb2 (.029%), Rg1 (.027%)) administered orally (capsule form). Participants have a 1 week wash-out between the active treatment and placebo.
Sponsors
Naturex
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
Yes
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.
Outcome results
None listed