None listed
Conditions
Brief summary
The aim of this study is to investigate the effects of 4 weeks of supplementation with a multivitamin and mineral preparation on brain activity and health as measured by cognitive function, mood, and nutritional status. The study will recruit healthy adults, aged 18-40 years, who 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, mood and cognitive assessment. A sub-sample will go on to complete an MRI assessment to explore changes in brain activity. The trial will test the predictions that 28-days treatment with the active multivitamin/mineral intervention will result in improved mood, increased functional brain activity, and improved cognitive performance under cognitive demand, when compared to those receiving placebo.
Interventions
Participants 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, dissolved in a glass of water (approx 200 ml) for a duration of 28 days. Treatment adherence will be monitored by the use of a compliance log which participants will take home with them and record
Participants 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, dissolved in a glass of water (approx 200 ml) for a duration of 28 days. Treatment adherence will be monitored by the use of a compliance log which participants will take home with them and record the time at which they take their tablet every day. If for some reason they miss a dose, they will be instructed to make a note of this in the log. In addition to the compliance log, participants will also be required to return all unused tablets at the completion of the study so that the experimenter can confirm that the number of tablets they have taken is in agreement with their log. The count of returned treatments will be used for compliance where these measures disagree. Each daily dose of Active treatment (Berocca Performance) 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
Sponsors
Swinburne University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
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 and MRI 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 MRI condition, only right handed participants will be recruited 5. Female subjects of childbearing age using an acceptable form of contraception (including hormonal methods (eg. oral contraceptive, hormonal implants), barrier methods (eg. male or female condom, diaphragm) or abstinence). 6. Fluent in spoken and written English
Exclusion criteria
1. History, or current diagnosis, of anxiety, depression, other psychiatric disorders, or dementia. 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 reasonably expected to affect the outcomes of the trial or interact with investigational products (routine medications to treat benign conditions, such as antibiotics to treat acne, are permissible) 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. History of serious head trauma, epilepsy or other neurological condition 6. Renal function problems, Hypercalcaemia; Hypermagnesemia, Severe hypercalciuria, phenylketonuria (autosomal metabolic disorder) 7. Currently pregnant or lactating 8. Participation in another trial within 30 days prior to the start of the study. 9. Hypersensitivity to the investigational product or any of the active/inactive ingredients 10. Any condition which may interfere with the subject’s ability to perform assessments (e.g. claustrophobia for the MRI arm, dyslexia). 11. People with metal implants (for MRI component only) 12. Left handed participants (for MRI component only). 13. Excessive alcohol consumption consistent with harmful or hazardous drinking, or alcohol use disorder
Outcome results
None listed