The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood

Launched by SWISSE WELLNESS PTY LTD · Mar 22, 2018

Keywords

ClinConnect Summary

This study will have two co-primary outcomes; one each to measure memory and focus. Short term memory will be measured by the spatial working memory task from the Swinburne University Computerised Cognitive Assessment Battery. Focus will be measured by the incongruent version of the stroop colour-word task from the Swinburne University Computerised Cognitive Assessment Battery. Through investigations of blood vitamin markers, biomarkers of inflammation and neuroimaging techniques, this study aims to provide insight to the mechanisms through which the supplement is acting.

This study is a p...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy males and females aged between 40 and 65 years
• • 2. Non-smokers
• • 3. English speaking
• • 4. Not currently being treated for anxiety, depression or psychiatric disorders (if treatment was \>2 years ago, can include)
• • 5. Not suffering from cognitive impairment
• • 6. No history of or currently suffering from neurological conditions (Epilepsy, Parkinsons, stroke, serious head trauma), cardiac diseases or diabetes requiring medication
• • 7. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs which might reasonably be expected to interfere with cognition or mood for 4 weeks prior to (and duration of) study, as defined by the exclusion list (Appendix 9)
• • 8. No health conditions that would affect absorption of food, including the following: food allergies, impaired kidney function , liver disease (Hepatitis C, cirrhosis) and/or gastrointestinal diseases (e.g. Inflammatory bowel disease (Ulcerative Colitis, Crohn's Disease), coeliac disease, peptic ulcers)
• • 9. Right handed (MRI component only)
• • 10. Not hypertensive (systolic \< 160 mm Hg and/or diastolic \< 100 mm Hg at rest)
• • 11. Not misusing substances
• • 12. Have internet access in the home
• • 13. Normal or corrected vision and normal colour vision
• • 14. Not currently participating, or has not participated in another study investigating a nutraceutical supplement within the past 4 weeks
• • 15. Not currently pregnant or lactating (for female participants of child bearing potential, the use of effective contraceptive method(s) for birth control for the duration of the study)
• • 16. Willing and able to provide written informed consent.
• • 17. Understands and is willing and able to comply with all study procedures.
• Exclusion Criteria:
• • 1. Chronic health condition
• • 2. Smoker
• • 3. Non-English speaking
• • 4. Treatment for anxiety, depression (Becks Depression Inventory score ≥20 to be confirmed at screening visit) or other psychiatric conditions within the past 2 years
• • 5. Suffering from cognitive impairment, dementia, Alzheimer's disease and/or a score of \<24 on the Mini-Mental State Examination (to be confirmed at screening visit)
• • 6. Neurological conditions (Epilepsy, Parkinsons, stroke, serious head trauma), cardiac diseases or diabetes requiring medication
• • 7. Use of concomitant medications and/or vitamin supplements that could have cognitive or mood effects in the 4 weeks preceding the baseline visit, as defined by the exclusion list (Appendix 9)
• • 8. Health conditions that would affect absorption of food, including the following: food allergies, impaired kidney function, liver disease (Hepatitis C, cirrhosis) and/or gastrointestinal diseases (e.g. Inflammatory bowel disease (Ulcerative Colitis, Crohn's Disease), coeliac disease, peptic ulcers)
• • 9. Left handed (MRI participants only)
• • 10. Blood pressure consistent with uncontrolled hypertension, (systolic \> 160 mm Hg and/or diastolic \> 100 mm Hg at rest)
• • 11. Alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week.
• • 12. Hypersensitivity to the investigational product or any of the active/inactive ingredients
• • 13. Currently taking Warfarin
• • 14. Currently participating, or has participated in another study investigating a nutraceutical supplement within the past 4 weeks
• • 15. People with metal implants, pacemaker or aneurism clip (MRI participants only)
• • 16. Currently pregnant or lactating
• • 17. Any condition which may interfere with the subject's ability to perform assessments (e.g. claustrophobia for the MRI arm, dyslexia, colour blindness)