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

Swisse Wellness

Status and phase: Completed; Phase 2

Conditions: Neurocognitive Function; Mood

Treatments: Other: Placebo; Dietary Supplement: Swisse Ultiboost Memory + Focus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03482063

MAST

Details and patient eligibility

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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141 participants in 2 patient groups, including a placebo group

Swisse Ultiboost Memory + Focus

Experimental group

Description:

two tablets daily, one tablet during or immediately after breakfast, and one tablet during or immediately after lunch, for the duration of the trial period

Treatment:

Dietary Supplement: Swisse Ultiboost Memory + Focus

Placebo

Placebo Comparator group

Description:

two tablets daily, one tablet during or immediately after breakfast, and one tablet during or immediately after lunch, for the duration of the trial period

Treatment:

Other: Placebo