None listed
Conditions
Brief summary
Multivitamin and multi-mineral supplementation has been shown to enhance cognitive functions. Previous study has suggested the reduction in fatigue and improve cognitive function following a 9-weeks supplementation while another study indicates improved cognitive function after 16- week supplementation. In another study acute multivitamin supplementation has also produce positive effect in contentment and cognitive task performance in adults. In addition, multivitamin supplementation for 12 weeks in children has improved cognitive performance. These studies suggested improved mood and cognitive functions/performance through supplementation even in the absence of vitamin deficiency by improving brain health. This study is undertaken to investigate the effect of a multivitamin and multi-mineral supplementation with high dose of B vitamins on neural connectivity, oxidative stress metabolism and cognitive performance after a 24 weeks of multivitamin and multi-mineral supplementation (Executive B Stress Formula from Blackmores, Australia). Hypothesis: The 24 weeks supplementation of a high-dose-B-vitamin multivitamin is expected to improve neural connectivity, oxidative metabolism and cognitive performance in healthy adults.
Interventions
Group 1: Executive B Stress, Blackmores, Australia containing Passiflora Incarnata herbal extract; Two oral tablets per day. Each tablet contains 56.6 mg Vitamin B1, 10 mg Vitamin B2, 100 mg Vitamin B3, 25.53 mg Vitamin B6, 250 mg Vitamin C, 30 IU Vitamin E, 75 mg Vitamin B5, 254.11 mg Magnesium phosphate pentahydrate, 30 mcg Vitamin B12, 50 mcg Biotin, 200 mcg Folic acid, 25 mg Choline bitartrate, 25 mg Inositol, 18.67 mg Zinc oxide, 75 mg Potassium sulphate, 100 mg dried Passiflora incarnata h
Group 1: Executive B Stress, Blackmores, Australia containing Passiflora Incarnata herbal extract; Two oral tablets per day. Each tablet contains 56.6 mg Vitamin B1, 10 mg Vitamin B2, 100 mg Vitamin B3, 25.53 mg Vitamin B6, 250 mg Vitamin C, 30 IU Vitamin E, 75 mg Vitamin B5, 254.11 mg Magnesium phosphate pentahydrate, 30 mcg Vitamin B12, 50 mcg Biotin, 200 mcg Folic acid, 25 mg Choline bitartrate, 25 mg Inositol, 18.67 mg Zinc oxide, 75 mg Potassium sulphate, 100 mg dried Passiflora incarnata herbal extract. Group 2: Executive B Stress, Blackmores, Australia without Passiflora Incarnata herbal extract; Two oral tablets per day. Each tablet contains 56.6 mg Vitamin B1, 10 mg Vitamin B2, 100 mg Vitamin B3, 25.53 mg Vitamin B6, 250 mg Vitamin C, 30 IU Vitamin E, 75 mg Vitamin B5, 254.11 mg Magnesium phosphate pentahydrate, 30 mcg Vitamin B12, 50 mcg Biotin, 200 mcg Folic acid, 25 mg Choline bitartrate, 25 mg Inositol, 18.67 mg Zinc oxide, 75 mg Potassium sulphate.
Sponsors
Taylor's University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy non-smoking males and females aged between 30 and 55 years • Not heavy consumers of alcohol (i.e., females consumed < 14 standard drinks per week, males consumed < 28 standard drinks per week) • No history of psychiatric disorders including clinical depression, anxiety or epilepsy • No history of / do not currently suffer from heart disease or high blood pressure or diabetes • Free from cognitive and memory impairment and does not suffer from any neurological disorders • Not taking any form of vitamin, mineral, herbal supplement, medications or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) the study such as multivitamins, B vitamins, Ginkgo biloba, antioxidants or other supplements • Not 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 • No clinically relevant abnormalities in their medical history that would render them ineligible for MRI • Not pregnant or possibility of being pregnant
Exclusion criteria
• Gluten intolerance • Having claustrophobia (fear of constrained space) • History of head injury/stroke • Evidence or history of any clinically significant (in the judgment of the investigator) renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, within the last 5 years • Clinically relevant abnormalities in their medical history that would render them ineligible for MRI • Currently taking Warfarin • Having metallic implants and other abnormalities in their medical history that would render them ineligible for MRI
Outcome results
None listed