The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood
Condition: Neurocognitive Function; Mood
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Swisse Ultiboost Memory + Focus; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): B vitamins help energy release, help with metabolism of food into energy, assist energy production and vitality.
Vitamin B5 helps support normal mental performance. Brahmi, Ginkgo, Vitamin B12 and B3 help support brain function. Ginkgo helps maintain healthy circulation and delivery of oxygenated blood to the brain.
Brahmi supports memory function and recall. Vitamin B5, B6 are important for adrenal function, assist adrenal glands during stress periods.
Vitamin B2, B3, B5, B6, B12 help relieve tiredness and fatigue.; riboflavin (2.2mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, placebo-controlled, double-blind, parallel groups design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: B vitamin; herbal supplement; attention