Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000698370
Ethics application status
Approved
Date submitted
9/05/2017
Date registered
16/05/2017
Date last updated
12/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effects of Ionix Supreme on stress, mood, energy and anxiety.
Scientific title
Examining the effects of Ionix Supreme on stress, mood, energy and anxiety in healthy younger adults.
Secondary ID [1] 291149 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 302003 0
Cognitive performance 302004 0
Anxiety 303265 0
Condition category
Condition code
Alternative and Complementary Medicine 301645 301645 0 0
Other alternative and complementary medicine
Mental Health 302687 302687 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 302688 302688 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ionix Supreme liquid
Oral liquid, 60mL daily for 4 weeks
Medicinal ingredients include (per 30ml)
Chinese Wolfberry 100 mg
Betaine hydrochloride 20mg
Velvet-bean 30 mg
Methylsulfonylmethane, synthetic 20mg
Maca 10 mg
Shilajeet 20mg
DL-alpha-Lipoic acid 25mg
Siberian-ginseng 25 mg
Ashwagandha 30 mg
Schisandra 15 mg
Tribulus 20 mg
Bacopa 25mg
Chebulic myrobalan 25mg
Roseroot 30mg
Indian-gooseberry 25mg
Niacinamide 13mg
Vitamin B6 6mg
Zinc 5mg
Vitamin B2 4mg
Ginger 5mg
Vitamin b12 120mcg
Yellow rhododendron 25mg

Non-medicinal ingredients:
Kiwi fruit extract, watermelon juice, Hibiscus flower, Silica, alfalfa extract, Blueberry extract, Stevia leaf, DL-malic acid, apple flavour, apple juice, sodium chloride, Water, molasses, potassium sorbate, potassium sorbate, sodium citrate

Compliance will be measured by measurement of returned liquid and by a treatment taking log
Intervention code [1] 297130 0
Treatment: Other
Comparator / control treatment
Placebo liquid
Oral liquid, 60mL daily for 4 weeks

Placebo is matched for taste and colour. It contains:
Stevia leaf, DL-malic acid, apple flavor, apple juice, sodium chloride, Water, molasses, potassium sorbate, potassium sorbate, sodium citrate
Control group
Placebo

Outcomes
Primary outcome [1] 301384 0
Perceived Stress
Measured using the Perceived Stress Scale
Timepoint [1] 301384 0
Baseline, week 1, week 2, week 3 and week 4 (post-treatment intervention)
Secondary outcome [1] 332518 0
Changes on the Profile of Mood states (POMS)
Timepoint [1] 332518 0
Baseline, week 1, week 2, week 3 and week 4 (post-treatment intervention)
Secondary outcome [2] 332519 0
Effects on Cognition
Measured by Purple multitasking framework
Timepoint [2] 332519 0
Baseline and week 4 (post-treatment intervention)
Secondary outcome [3] 332520 0
Effects on biochemical measures from blood samples.
Oxidative stress markers (F2 Isoprostanes, High Sensitivity C-Reactive Protein (HsCRP) and Fibrinogen).
Timepoint [3] 332520 0
Baseline and week 4 (post-treatment intervention)
Secondary outcome [4] 334608 0
Brain Imaging.
A sub-group will complete functional MRI task and MRS scan
Functional MRI scans will measure changes in the bold response during the RVIP and n-back tasks.
Timepoint [4] 334608 0
Baseline and week 4 (post-treatment intervention)
Secondary outcome [5] 334717 0
Changes on the General Health Questionnaire (GHQ)
Timepoint [5] 334717 0
Baseline, week 1, week 2, week 3 and week 4 (post-treatment intervention)
Secondary outcome [6] 334718 0
Changes on the workplace stress questionnaire
Timepoint [6] 334718 0
Baseline, week 1, week 2, week 3 and week 4 (post-treatment intervention)
Secondary outcome [7] 334719 0
Changes in subjective stress, measured on the State Trait Anxiety Inventory - State version (STAI-S), after completing the cognitive tasks
Timepoint [7] 334719 0
baseline and week 4 (post-treatment intervention)
Secondary outcome [8] 334720 0
changes in subjective mood and stress after completing the cognitive tasks, measured by the Bond-Lader Visual analogue scales.
Timepoint [8] 334720 0
baseline and week 4 (post-treatment intervention)
Secondary outcome [9] 334721 0
Changes in cognition measured by CogTrack
Timepoint [9] 334721 0
Baseline and week 4 (post-treatment intervention)
Secondary outcome [10] 334722 0
Changes in blood vitamin status
measured by Vitamin B6, B12 and Red Cell Folate
Timepoint [10] 334722 0
Baseline and week 4 (post-treatment intervention)
Secondary outcome [11] 334723 0
Assessment of blood safety parameters
Measured by Kidney and Liver function tests
Timepoint [11] 334723 0
Baseline and week 4 (post-treatment intervention)
Secondary outcome [12] 334724 0
Stress hormone measurement
Measured in saliva cortisol
Timepoint [12] 334724 0
Baseline and week 4 (post-treatment intervention)
Secondary outcome [13] 334725 0
Brain Imaging
A sub-group will complete functional MRI task and MRS scan
Assessment of the biochemical changes in the brain due to the intervention - measured by Magnetic Resonance Spectroscopy (MRS)
Timepoint [13] 334725 0
Baseline and week 4 (post-treatment intervention)

Eligibility
Key inclusion criteria
Fluent in written and spoken English
In good general health
Normal or corrected to normal vision
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoker
Diabetes, cardiovascular disease, epilepsy, Parkinson's Disease,
Dementia, stroke or other neurological conditions,
depression/anxiety or other psychiatric conditions in the last 2 years,
endocrine, gastrointestinal or bleeding disorders.
Alcohol abuse (past/present)
If female, not currently pregnant or lactating
Use of antidepressant or anti-anxiety medications
Use of high dose anti-coagulant medications
Use of vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort or other cognitive enhancing dietary or herbal supplement in the 4 weeks preceding the baseline study visit

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment bottles only identified by treatment code. Code is held by a third party.
Randomisation conducted by personnel who had no other involvement in the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randmisation
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2017
Actual
27/09/2017
Date of last participant enrolment
Anticipated
Actual
17/07/2018
Date of last data collection
Anticipated
Actual
10/08/2018
Sample size
Target
78
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15512 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 295585 0
Commercial sector/Industry
Name [1] 295585 0
Isagenix Worldwide LLC
Country [1] 295585 0
United States of America
Primary sponsor type
University
Name
Swinburne University of Technology, Centre for Human Psychopharmacology
Address
427-451 Burwood Rd,
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 294416 0
None
Name [1] 294416 0
Address [1] 294416 0
Country [1] 294416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296907 0
Bellberry Limited
Ethics committee address [1] 296907 0
Ethics committee country [1] 296907 0
Australia
Date submitted for ethics approval [1] 296907 0
03/03/2017
Approval date [1] 296907 0
20/06/2017
Ethics approval number [1] 296907 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72398 0
A/Prof Luke Downey
Address 72398 0
Centre for Human Psychopharmacology
Swinburne University of technology
427-451 Burwood Rd
Hawthorn VIC 3122
Country 72398 0
Australia
Phone 72398 0
+61 3 92145781
Fax 72398 0
Email 72398 0
[email protected]
Contact person for public queries
Name 72399 0
Luke Downey
Address 72399 0
Centre for Human Psychopharmacology
Swinburne University of Technology
427-451 Burwood Rd
Hawthorn VIC 3122
Country 72399 0
Australia
Phone 72399 0
+61 3 92145781
Fax 72399 0
Email 72399 0
[email protected]
Contact person for scientific queries
Name 72400 0
Luke Downey
Address 72400 0
Centre for Human Psychopharmacology
Swinburne University of Technology
427-451 Burwood Rd
Hawthorn VIC 3122
Country 72400 0
Australia
Phone 72400 0
+61 3 92145781
Fax 72400 0
Email 72400 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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