Effects of a multivitamin preparation on brain function.

Effects of 4 weeks supplementation with a multivitamin/mineral preparation on brain function in healthy volunteers assessed with Steady State Topography and fMRI during periods of mental effort: A randomized, double-blind, placebo controlled trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001043820

Enrollment

Registered

2012-10-02

Start date

2013-02-14

Completion date

2014-08-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of this pilot, exploratory study is to investigate the effects of 4 weeks supplementation with a multivitamin/mineral preparation on brain activity and nutritional status assessed via established functional imaging techniques and blood biomarkers of health in healthy volunteers. Participants will attend two testing sessions, one baseline and one after 4-weeks supplementation. During testing sessions participants will complete a series of common assessments including nutritional status and mood assessment. They will all undergo SST and a sub sample will go on to complete fMRI. Following baseline participants will be randomly assigned to one of two treatments: 1) Berocca Performance 2)Placebo (matched for appearance, taste and smell) Following 4-week daily supplementation with allocated treatment participants will return for their second testing day.

Interventions

Participant will be randomly assigned to one of the following treatments: 1)Berocca Performance (registered trademark) 2)Placebo: Matched for appearance, taste and smell. Treatments will be administered in the form of effervescent tablets. Participants will be instructed to take one tablet daily, before lunch, dissolved in a glass of water for a duration of 28 days. Each Berocca Performance tablet contains: Vitamin C 500mg Thiamine Monophosphoric acid ester chloride 18.54mg Riboflavin

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

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.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).

Outcome results