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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Changes in short term memory, as measured by the spatial working memory task from the Swinburne University Computerised Cognitive Assessment Battery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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)
- •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.
- •Understands and is willing and able to comply with all study procedures.
排除标准
- •Chronic health condition
- •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
- •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)
- •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
- •Any condition which may interfere with the subject's ability to perform assessments (e.g. claustrophobia for the MRI arm, dyslexia, colour blindness)
结局指标
主要结局
Changes in short term memory, as measured by the spatial working memory task from the Swinburne University Computerised Cognitive Assessment Battery.
时间窗: 12 weeks
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.
Changes in focus, as measured by the incongruent version of the stroop colour-word task from the Swinburne University Computerised Cognitive Assessment Battery
时间窗: 12 weeks
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
次要结局
- Neuroimaging(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)
- Profile of Mood States (PROMS)(12 weeks)
- Immediate/Delayed Recognition component of the Swinburne University Computerised Cognitive Battery (SUCCAB)(12 weeks)
- Serial Threes Subtraction component of the Cognitive Demand Battery(12 weeks)
- Serial Sevens Subtraction component of the Cognitive Demand Battery(12 weeks)
- Rapid Visual Information Processing component of the Cognitive Demand Battery(12 weeks)
- Perceived Stress Scale (PSS)(12 weeks)
- Choice reaction time component of the Swinburne University Computerised Cognitive Battery (SUCCAB)(12 weeks)
- Bond-Lader Visual Analogue Scales (VAS)(12 weeks)
- Prospective and Retrospective Memory Questionnaire (PRMQ)(12 weeks)
- Simple reaction time component of the Swinburne University Computerised Cognitive Aging Battery (SUCCAB)(12 weeks)
- The Depression, Anxiety and Stress Scale (DASS)(12 weeks)
- Stress, Anxiety, Mental Fatigue, Concentration and Mental Stamina Visual Analogue Mood Scales (VAMS)(12 weeks)
- State-Trait Anxiety Inventory - State Subscale (STAI-S)(12 weeks)
- Biomedical measures(12 weeks)
- Chalder Fatigue Scale (CFS)(12 weeks)
- Subjective Experience Survey(12 weeks)