None listed
Conditions
Brief summary
This study will follow a randomized, double blind, placebo-controlled, cross over design. 20 participants will complete the study, of which 15 will take part in the SST/CDB part and 5 participants will take part in the fMRI component with the RVIP and inspection time tasks. For the 15 participant group, they will attend 3 testing days and will first do baseline testing of the CDB, followed by treatment administration and post dose testing of all tasks at 30min post dose (post dose testing will consist of CDB and SST. For the fMRI group, participants will consume their allocated treatment and undergo the cognitive tasks in the fMRI scanner 30mins post dose.
Interventions
Participants will be given a treatment (drink) pre-prepared by the investigator. Each treatment will consist of one effervescent tablet mixed with water as per the manufacturer’s recommended dosage. Investigational products will be administered once orally (with approximately 1 week wash-out between investigational products).
The 3 treatments are:
- Berocca Performance (Registered Trademark)
- Berocca Boost (Registered Trademark)
- Placebo (matched for taste and appearance)
Each Berocca Perfor
Participants will be given a treatment (drink) pre-prepared by the investigator. Each treatment will consist of one effervescent tablet mixed with water as per the manufacturer’s recommended dosage. Investigational products will be administered once orally (with approximately 1 week wash-out between investigational products). The 3 treatments are: - Berocca Performance (Registered Trademark) - Berocca Boost (Registered Trademark) - Placebo (matched for taste and appearance) Each Berocca Performance tablet (effervescent) contains: Vitamin C 500mg Thiamine Monophosphoric acid ester chloride 18.54mg Riboflavin (Vitamin B2) 15mg Nicotinamide (B3/niacin) 50mg Vitamin B5 23mg Vitamin B6 10mg Vitamin B12 0.01mg Folic Acid (Vitamin B9) 0.4mg Biotin (Vitamin B7) 0.15mg Calcium 100mg Magnesium 100mg Zinc 10mg Each Berocca Boost tablet (effervescent) contains: Vitamin B1 1.40mg Vitamin B2 1.60mg Nicotinamide 18mg Pantothenic Acid 6mg Vitamin B6 2mg Folic Acid 200ug Vitamin B12 1ug Biotin 150ug Vitamin C 60mg Calcium 100mg Magnesium 100mg Zinc 9.50mg Guarana (containing 40mg of caffeine) 222.2mg All participants will be randomized to one cell of a Latin Square representing one of the following treatment orders: 1. PLACEBO => BEROCCA PERFORMANCE => BEROCCA BOOST 2. PLACEBO => BEROCCA BOOST => BEROCCA PERFORMANCE 3. BEROCCA PERFORMANCE => BEROCCA BOOST => PLACEBO 4. BEROCCA PERFORMANCE => PLACEBO => BEROCCA BOOST 5. BEROCCA BOOST => PLACEBO=> BEROCCA PERFORMANCE 6. BEROCCA BOOST =>BEROCCA PERFORMANCE => PLACEBO
Sponsors
Swinburne University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, non-smoking, males and females aged 18-40 2. Are comfortable with computers, EEG (not photosensitive or sensitive to flashing lights) and fMRI and willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol. 3. Provide a personally signed and dated informed consent indicating that the participant has been informed of all pertinent aspects of the trial. 4. Must be right-handed
Exclusion criteria
1. History of anxiety, depression, psychiatric disorders. 2. Currently suffering from/ or have history of heart disease or high blood pressure or diabetes 3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study 4. 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 5. 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) 6. Epilepsy/Photosensitive or unable to look at flashing lights 7. Left handed participants. This is for ease of analysis looking at the fMRI. There are hemispheric differences in terms of structure between right and left handed individuals that prove to be problematic when analysing the output. Given that this investigation will employ a method where participants need to press buttons as a response (in turn involving the motor cortex), it is wise to use an all right handed population. 8. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder), 9. Currently pregnant or lactating 10. People with metal implants (for MRI component)
Outcome results
None listed