Effects of a multivitamin preparation on brain function.

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 56

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.For participants in the fMRI condition, only right handed participants will be recruited
5.Female subjects of childbearing age using an acceptable form of contraception
6.Fluent in spoken and written English

Exclusion Criteria

1. History of or currently suffering from anxiety, depression, psychiatric disorders.
2. History of / currently suffering from heart disease, high blood pressure or diabetes
3. Taking any medication, herbal extracts, vitamin supplements or illicit drugs within 4 weeks prior to (and duration of) study (except for routine medications to treat benign conditions, such as antibiotics to treat acne), or excessive consumption of caffeine or alcohol in this period, 4. 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)
5. Epilepsy/Photosensitive or unable to look at flashing lights
6. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder)
7. Currently pregnant or lactating
8. Left handed participants (for fMRI component only). 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.
9. People with metal implants (for fMRI component only)
10. Vital signs out of the normal range (blood pressure, pulse rate, body temperature)
11. History of head trauma
12. Hypersensitivity to the investigational product or any of the active/inactive ingredients
13. Participation in another trial within 30 days prior to the start of the study.
14. Any condition which may interfere with the subject’s ability to perform assessments (e.g. claustrophobia for the fMRI arm, dyslexia, limb deformity).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional brain activity changes associated with supplementation (SST latency and amplitude, as well as fMRI BOLD response).[Baseline and day 28; following daily supplementation with Berocca or Placebo]

Secondary Outcome Measures

Name	Time	Method
Cognitive performance as assessed by the following tasks:<br>A-X Continuous Performance Task<br>Spatial Working Memory<br>Rapid Visual Information Processing<br>Inspection Time[Baseline and day 28; following daily supplementation with Berocca or Placebo];Mood as assessed by the following questionnaires:<br>Profile of Mood States (POMS)<br>State-Trait Anxiety Inventory<br>Perceived Stress Scale (PSS)<br>Bond-Lader Visual Analog Mood Scales<br>Stress, Fatigue and Energy Visual Analogue Scales (VAS)[Pre-SST and Post-SST at Baseline and day 28.]