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

Sponsored by Swisse Wellness Pty Ltd

About this trial

Last updated 5 years ago

Study ID

MAST

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18-75 Years
40 to 65 Years
All
All

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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)