Clinical trial NCT03482063: The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood
Official title: The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood: The Memory + Focus Clinical Trial (MAST - Memory and Attention Supplement Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neurocognitive Function
Mood
Keywords: B vitamin
herbal supplement
attention
Lead sponsor: Swisse Wellness Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Swinburne University of Technology
First posted: 2018-03-29
Enrollment: 141
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, placebo-controlled, double-blind, parallel groups design
Primary purpose: SUPPORTIVE_CARE

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 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 phase II clinical trial, which will follow a randomised, placebo-controlled, double-blind, parallel groups design. One hundred and forty participants will complete a 12 week intervention, which will involve three testing visits to Swinburne University, as well as in-home mood assessments. Of these, 60 participants will also complete an MRI component. Participants will be randomly allocated to one of two groups; one receiving active supplementation of Swisse Ultiboost Memory + Focus, and the other receiving a placebo formulation.

Prior to participants being enrolled in the study a telephone screening interview will be completed, to reduce the likelihood of ineligible participants attending study visits. Eligible participants will complete three study visits; a Screening and Practice visit (V0), Baseline Visit (V1), and the Final Visit (V2). The participant's baseline visit (V1) will be scheduled within two weeks of their screening and practice visit (V0). The participant's final visit (V2) will be scheduled 12 weeks (± 3 days) from the baseline visit (V1). Therefore, it is anticipated that participation in the trial will last a maximum of 14 weeks.

For the 12 week supplementation period between their baseline (V1) and final (V2) visits, participants will be instructed to consume one tablet, twice a day, of either Swisse Ultiboost Memory + Focus or placebo, with a meal. Participants will be requested to abstain from the treatment on the day of their final visit.

Participants will also be required to complete online mood assessments in their home, twice a week for the duration of the 12 week supplementation period. Two laboratory assessment points will be measured, at baseline (V1) and at the final visit (V2). Twenty four in-home assessment points will be measured, twice a week during participation in the study.

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)

Primary outcomes:
measure: Changes in short term memory, as measured by the spatial working memory task from the Swinburne University Computerised Cognitive Assessment Battery.
timeFrame: 12 weeks
measure: Changes in focus, as measured by the incongruent version of the stroop colour-word task from the Swinburne University Computerised Cognitive Assessment Battery
timeFrame: 12 weeks
Secondary outcomes:
measure: Simple reaction time component of the Swinburne University Computerised Cognitive Aging Battery (SUCCAB)
timeFrame: 12 weeks
measure: Choice reaction time component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
timeFrame: 12 weeks
measure: Immediate/Delayed Recognition component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
timeFrame: 12 weeks
measure: Stroop Colour-Word component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
timeFrame: 12 weeks
measure: Contextual memory component of the Swinburne University Computerised Cognitive Battery (SUCCAB)
timeFrame: 12 weeks
measure: Serial Threes Subtraction component of the Cognitive Demand Battery
timeFrame: 12 weeks
measure: Serial Sevens Subtraction component of the Cognitive Demand Battery
timeFrame: 12 weeks
measure: Rapid Visual Information Processing component of the Cognitive Demand Battery
timeFrame: 12 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 12 weeks
measure: Profile of Mood States (PROMS)
timeFrame: 12 weeks
measure: The Depression, Anxiety and Stress Scale (DASS)
timeFrame: 12 weeks
measure: State-Trait Anxiety Inventory - State Subscale (STAI-S)
timeFrame: 12 weeks
measure: Bond-Lader Visual Analogue Scales (VAS)
timeFrame: 12 weeks
measure: Stress, Anxiety, Mental Fatigue, Concentration and Mental Stamina Visual Analogue Mood Scales (VAMS)
timeFrame: 12 weeks
measure: Prospective and Retrospective Memory Questionnaire (PRMQ)
timeFrame: 12 weeks
measure: Chalder Fatigue Scale (CFS)
timeFrame: 12 weeks
measure: Subjective Experience Survey
timeFrame: 12 weeks
measure: Biomedical measures
timeFrame: 12 weeks
measure: Neuroimaging
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hawthorn
country: Australia
facility: Swinburne University of Technology
state: Victoria
Study officials:
affiliation: Swinburne University
name: Andrew Pipingas
role: PRINCIPAL_INVESTIGATOR
References: