Status:
COMPLETED
The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood
Lead Sponsor:
Swisse Wellness Pty Ltd
Collaborating Sponsors:
Swinburne University of Technology
Conditions:
Neurocognitive Function
Mood
Eligibility:
All Genders
40-65 years
Phase:
PHASE2
Brief Summary
The aim of the present study is to evaluate chronic supplementation with Swisse Ultiboost Memory + Focus over a 12 week period on memory in individuals with optimal and sub-optimal nutrient profiles.
Detailed Description
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 Cog...
Eligibility Criteria
Inclusion
- Healthy males and females aged between 40 and 65 years
- Non-smokers
- English speaking
- Not currently being treated for anxiety, depression or psychiatric disorders (if treatment was \>2 years ago, can include)
- Not suffering from cognitive impairment
- No history of or currently suffering from neurological conditions (Epilepsy, Parkinsons, stroke, serious head trauma), cardiac diseases or diabetes requiring medication
- 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)
- 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)
- Right handed (MRI component only)
- Not hypertensive (systolic \< 160 mm Hg and/or diastolic \< 100 mm Hg at rest)
- Not misusing substances
- Have internet access in the home
- Normal or corrected vision and normal colour vision
- Not currently participating, or has not participated in another study investigating a nutraceutical supplement within the past 4 weeks
- 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)
- Willing and able to provide written informed consent.
- Understands and is willing and able to comply with all study procedures.
Exclusion
- Chronic health condition
- Smoker
- Non-English speaking
- Treatment for anxiety, depression (Becks Depression Inventory score ≥20 to be confirmed at screening visit) or other psychiatric conditions within the past 2 years
- 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)
- Neurological conditions (Epilepsy, Parkinsons, stroke, serious head trauma), cardiac diseases or diabetes requiring medication
- 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)
- 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)
- Left handed (MRI participants only)
- Blood pressure consistent with uncontrolled hypertension, (systolic \> 160 mm Hg and/or diastolic \> 100 mm Hg at rest)
- Alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week.
- Hypersensitivity to the investigational product or any of the active/inactive ingredients
- Currently taking Warfarin
- Currently participating, or has participated in another study investigating a nutraceutical supplement within the past 4 weeks
- People with metal implants, pacemaker or aneurism clip (MRI participants only)
- Currently pregnant or lactating
- Any condition which may interfere with the subject's ability to perform assessments (e.g. claustrophobia for the MRI arm, dyslexia, colour blindness)
Key Trial Info
Start Date :
June 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2020
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT03482063
Start Date
June 18 2018
End Date
January 9 2020
Last Update
March 18 2020
Active Locations (1)
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1
Swinburne University of Technology
Hawthorn, Victoria, Australia, 3122