Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000062527
Ethics application status
Approved
Date submitted
8/01/2015
Date registered
23/01/2015
Date last updated
15/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled, crossover trial investigating the effects of two nutraceutical combination formulas on mental fatigue, mood and neurocognitive performance in healthy adults.
Scientific title
A randomised, double-blind, placebo-controlled, crossover trial investigating the effects of two nutraceutical combination formulas on mental fatigue, mood and neurocognitive performance in healthy adults.
Secondary ID [1] 285730 0
***
Universal Trial Number (UTN)
***
Trial acronym
***
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental fatigue
 293616 0
Cognitive function
 293950 0
Self-rated mood
 293951 0
Cerebral blood flow and oxygen metabolism
 293952 0
Brain biochemistry 293953 0
Condition category
Condition code
Diet and Nutrition 293902 293902 0 0
Other diet and nutrition disorders
Mental Health 293903 293903 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 293904 293904 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigational products will be administered once orally (with approximately 1 week wash-out between investigational products). Participants will consume a different treatment each testing day. Each product consists of a powdered drink mix, which is to be dissolved in 500ml of water prior to consumption.

The intervention will be consumed at the testing centre by healthy volunteers while under researcher supervision

The following products will be investigated:

ErgGo MOM contains:
Green tea extract (130mg including 13mg of caffeine)
Quercetin (100mg)
Enzogenol (50mg)
Magnesium (50mg)
L-Theanine (25mg)
Niacin (20mg)
Vitamin B6 (2mg)
Vitamin B12 (400mcg)
Maltodextrin plus stevia (sweetener) and natural flavour/colour
Citric Acid, Gum Acacia, Guar Gum, Xanthan Gum

ErgGo POP contains:
DMAE (dimethylaminoethanol, 200mg)
Green tea extract (130mg including 13mg of caffeine)
Quercetin (100mg)
Caffeine (87mg)
Enzogenol (50mg)
Magnesium (50mg)
L-Theanine (25mg)
Niacin (20mg)
Vitamin B6 (2mg)
Vitamin B12 (400mcg)
Maltodextrin plus stevia (sweetener) and natural flavour/colour
Citric Acid, Gum Acacia, Guar Gum, Xanthan Gum
Intervention code [1] 290686 0
Treatment: Drugs
Comparator / control treatment
Matched placebo contains:
Maltodextrin plus stevia (sweetener) and natural flavour/colour
Citric Acid, Gum Acacia, Guar Gum, Xanthan Gum
Control group
Placebo

Outcomes
Primary outcome [1] 293677 0
Effects of supplementation on mental fatigue assessed by measuring changes in self-reported mental fatigue induced by the completion of the Cognitive Demand Battery (a cognitively taxing battery of tasks)
Timepoint [1] 293677 0
45-85 minutes post dose at each of the three visits where a treatment is given
Secondary outcome [1] 311579 0
Effects of supplementation on cognitive function assessed by measuring performance on both the Cognitive Demand Battery and the Swinburne University Computerized Cognitive Assessment Battery (SUCCAB)
Timepoint [1] 311579 0
45-85 minutes post dose at each of the three visits where a treatment is given
Secondary outcome [2] 311580 0
Effects of supplementation on self-reported mood assessed by the Bond and Lader Visual Analogue Scale
Timepoint [2] 311580 0
45-85 minutes post dose at each of the three visits where a treatment is given
Secondary outcome [3] 311581 0
Effects of supplementation on brain function (functional brain activity, cerebral blood flow oxygen metabolism and brain biochemistry) assessed by Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopy (MRS)
Timepoint [3] 311581 0
90 minutes post dose at each of the three visits where a treatment is given

Eligibility
Key inclusion criteria
Healthy adults aged 20 to 50 years
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participant experiences or evidence of delirium, confusion, or other disturbance of consciousness.
Participant has any diagnosed illness or disorder affecting cognitive function or mood such as depression, anxiety, stroke or dementia.
Individuals currently taking prescription medication other than a contraceptive pill.
Any significant concurrent illness including any bleeding disorders, coronary heart disease, diabetes, gastrointestinal disorder.
Any known or suspected food allergies (this would cover all ingredients in the investigational product).
Participant has a recent history of (within 12 months of V1) or strong potential for alcohol or substance abuse.
Participant is a female, who is pregnant, planning to be pregnant during the study period, or lactating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation was performed by a person external to this study.

All treatments are presented in identically appearing plain packaging, differing only by a participant and visit number.

To assist with blinding, all treatments are matched for taste and appearance.

Eligible participants are assigned the next sequential participant/randomisation number in the format starting 001, 002.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
3-way Latin Square Design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
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Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
All statistical analyses will be conducted using IBM SPSS v21. The primary analyses will involve repeated measures ANOVA on ‘change from baseline’ data for each Cognitive Demand Battery (CDB) measure. At each cycle of the CDB, the scores will be compared across each of the three treatment groups using planned comparisons, correcting for multiple comparisons. Planned comparisons will compare each active treatment group with that of placebo. Similar statistical tests will be used to analyse the remaining outcomes. All tests of significance, unless otherwise stated, will be performed at alpha = 0.05, two-sided.

A sample of 24 participants is required to complete the crossover protocol. Assuming a medium effect size (d = 0.3), which is based on previous literature in this area, this number will give 80% power to detect a significant (p <0.05, two tailed) difference between treatments (G* Power v3.1). A sample of 30 participants (15 females and 15 males) will be recruited to account for participant withdrawal.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/01/2015
Actual
14/01/2015
Date of last participant enrolment
Anticipated
Actual
16/07/2015
Date of last data collection
Anticipated
Actual
13/08/2015
Sample size
Target
30
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9088 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 290514 0
Commercial sector/Industry
Name [1] 290514 0
LifeVantage Corporation
Country [1] 290514 0
United States of America
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Advanced Technologies Centre
Burwood Road
Hawthorn, 3122
VIC
Country
Australia
Secondary sponsor category [1] 289275 0
Commercial sector/Industry
Name [1] 289275 0
LifeVantage Corporation
Address [1] 289275 0
9785 S. Monroe Street Suite 300
Sandy, UT, 84070
USA
Country [1] 289275 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292013 0
Bellberry Human Research Ethics Committee (HREC)
Ethics committee address [1] 292013 0
129 Glen Osmond Road
Eastwood
South Australia
5063
Ethics committee country [1] 292013 0
Australia
Date submitted for ethics approval [1] 292013 0
Approval date [1] 292013 0
17/11/2014
Ethics approval number [1] 292013 0
Bellberry HREC 2014-07-422

Summary
Brief summary
The primary purpose of this study is to evaluate whether acute supplementation with either of two nutraceutical combination formulas (ErgGo Mom and ErgGo POP), relative to placebo, reduces self-rated mental fatigue associated with performing cognitively demanding tasks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53042 0
A/Prof Andrew Pipingas
Address 53042 0
Centre for Human Psychopharmacology
Swinburne University of Technology (SUT)
Advanced Technologies Centre
Burwood Road
Hawthorn
VIC 3122
Country 53042 0
Australia
Phone 53042 0
+61 03 9214 5215
Fax 53042 0
Email 53042 0
[email protected]
Contact person for public queries
Name 53043 0
Andrew Pipingas
Address 53043 0
Centre for Human Psychopharmacology
Swinburne University of Technology (SUT)
Advanced Technologies Centre
Burwood Road
Hawthorn
VIC 3122
Country 53043 0
Australia
Phone 53043 0
+61 03 9214 5215
Fax 53043 0
Email 53043 0
[email protected]
Contact person for scientific queries
Name 53044 0
Andrew Pipingas
Address 53044 0
Centre for Human Psychopharmacology
Swinburne University of Technology (SUT)
Advanced Technologies Centre
Burwood Road
Hawthorn, 3122
Country 53044 0
Australia
Phone 53044 0
+61 03 9214 5215
Fax 53044 0
Email 53044 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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