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

NCT03482063 | Completed Phase 2

• 1 other identifier: MAST
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Function; Mood

Keywords

B vitamin; herbal supplement; attention

Outcome Measures

Primary Outcomes (2)

• Changes in short term memory, as measured by the spatial working memory task from the Swinburne University Computerised Cognitive Assessment Battery.

  In each trial participants are presented with a 4x4 white grid on a black background, with six grid positions containing white squares. Participants are given 3 seconds to remember where the white squares are located. The grid became blank and a series of four white squares were sequentially displayed in various grid positions for 2-seconds each. Participants responded with a yes/no response to indicate whether each square matched a position that was originally filled. In total, participants complete 14 trials, each of which are separated by a blank screen displayed for 2-seconds. Each trial was set such that two out of the four locations in the response series corresponded to the original grid locations, and two did not. The task requires participants to hold spatial information in working memory.

  12 weeks

• Changes in focus, as measured by the incongruent version of the stroop colour-word task from the Swinburne University Computerised Cognitive Assessment Battery

  The test consists of congruent and incongruent trials blocks. Stimulus words are randomly presented (RED, BLUE, GREEN, YELLOW), printed in colours either congruent or incongruent with the written word. Participants are asked to respond by pressing one of four buttons corresponding to the colour of the print while ignoring the written word. The tasks are participant-paced, meaning that as soon as a participant responds to a word, they are presented with the next word. The incongruent trial will be used as a measure of selective attention as participants are required to selectively attend to the print colour of the written word, while inhibiting the automatic reading of the written word

  12 weeks

Secondary Outcomes (19)

• Simple reaction time component of the Swinburne University Computerised Cognitive Aging Battery (SUCCAB)

  12 weeks

• Choice reaction time component of the Swinburne University Computerised Cognitive Battery (SUCCAB)

  12 weeks

• Immediate/Delayed Recognition component of the Swinburne University Computerised Cognitive Battery (SUCCAB)

  12 weeks

• Stroop Colour-Word component of the Swinburne University Computerised Cognitive Battery (SUCCAB)

  12 weeks

• Contextual memory component of the Swinburne University Computerised Cognitive Battery (SUCCAB)

  12 weeks

Study Arms (2)

Swisse Ultiboost Memory + Focus

EXPERIMENTAL

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

Dietary Supplement: Swisse Ultiboost Memory + Focus

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Swisse Ultiboost Memory + Focus DIETARY_SUPPLEMENT

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.

Swisse Ultiboost Memory + Focus

Placebo OTHER

riboflavin (2.2mg)

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Swisse Wellness Pty Ltd: lead
• Swinburne University of Technology: collaborator

Study Sites (1)

Swinburne University of Technology

Hawthorn, Victoria, 3122, Australia

Location

Study Officials

• Andrew Pipingas

  Swinburne University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, placebo-controlled, double-blind, parallel groups design

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 29, 2018
• Study Start: June 18, 2018
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)