Acute effects of multi-vitamin/mineral preparations on brain imaging during periods of mental effort

Phase 4

Completed

• Conditions: Cognitive function; Mental Health - Studies of normal psychology, cognitive function and behaviour; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12612001116819
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive performance on Spatial Working Memory, Continuous performance, and Cognitive Demand Battery[Baseline and 30 mins post dose]

Secondary Outcome Measures

Name	Time	Method
Steady State Topography latency and amplitude[30 mins post dose];Mood (alert, calm, content, stress, fatigue, tiredness) using Profile of Mood States (POMS), State-Trait Anxiety Inventory, Bond Lader and Stress and Fatigue Visual Analogue Mood Scales (VAMS)[Baseline and 30 mins post dose];fMRI brain imaging (and performance on RVIP and Inspection Time tasks)[30 mins post dose]