Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000462684
Ethics application status
Approved
Date submitted
24/04/2014
Date registered
2/05/2014
Date last updated
14/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Glycomax 'Trademark' lactoferrin and bovine whey immunoglobulin-rich fraction on gene expression patterns in healthy adults: a double-blind placebo-controlled randomised clinical trial
Scientific title
In healthy adults do Glycomax 'Trademark' lactoferrin and bovine whey immunoglobulin-rich fraction supplements influence gene expression patterns?
Secondary ID [1] 284166 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Function in Healthy Adults 291262 0
Condition category
Condition code
Inflammatory and Immune System 291607 291607 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplementation for 28 days with oral supplements once daily from one of six possible treatments
Arm 1: Lactoferrin 200mg
Arm 2: Whey Ig-rich Fraction 200mg
Arm 3: Whey Ig-rich Fraction 800mg
Arm 4: Lactoferrin 200mg + Whey Ig-rich fraction 200mg
Arm 5: Lactoferrin 200mg + Whey Ig-rich faction 800mg
Arm 6: Placebo

Compliance will be encouraged with a daily checklist and monitored by supplement return at the end of the intervention period.
Intervention code [1] 288866 0
Treatment: Other
Comparator / control treatment
Placebo (mannitol and calcium carbonate based tablets)
Control group
Placebo

Outcomes
Primary outcome [1] 291551 0
Change in whole genome gene expression patterns (determined using expression arrays) in response to the intervention.
Timepoint [1] 291551 0
Intervention period is 28 days.
Primary endpoints will be determined at day 28.
Secondary outcome [1] 307054 0
Self-reported illness symptoms reported via the Wisconsin Upper Respiratory Symptom Survey-11
Timepoint [1] 307054 0
Day 28

Eligibility
Key inclusion criteria
For inclusion into the study, participants are required to be:
aged between 18-55 years;
in current good health;
have Body Mass Index (BMI) <30 kg/m2
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from participation if they:
are lactose intolerant;
consume of fish oil, probiotics, prebiotics, whey protein supplements during the trial period;
require insulin use (for treatment of diabetes);
have a history of liver, kidney or thyroid disease;
use anti-inflammatory or immune-modulating medications; have heavy alcohol consumption (according to the CDC definitions);
are pregnant or intending to become pregnant during the trial period;
have had high level of radiation exposure over the preceding 12 months

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)
Subjects will be randomly allocated to one of six treatment groups using simple block randomization. Groups will be coded numerically and the allocation code concealed from the research team in sealed envelopes for the duration of the trail.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Given the multiple treatment arms in this trial, simple block randomisation will be used for subject allocation. This involves ordering the six treatment groups in a series of randomly sequenced repeating blocks. Consecutively recruited participants are then allocated to a group based on the sequence of the current block.
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
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
7/07/2014
Date of last participant enrolment
Anticipated
Actual
28/04/2015
Date of last data collection
Anticipated
Actual
26/05/2015
Sample size
Target
120
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288798 0
Commercial sector/Industry
Name [1] 288798 0
Probiotec Pharma Pty Ltd
Country [1] 288798 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Gold Coast Campus
University Drive
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 287493 0
None
Name [1] 287493 0
Address [1] 287493 0
Country [1] 287493 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290641 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 290641 0
Ethics committee country [1] 290641 0
Australia
Date submitted for ethics approval [1] 290641 0
Approval date [1] 290641 0
12/02/2014
Ethics approval number [1] 290641 0
MED/32/13/HREC

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

Contacts
Principal investigator
Name 46558 0
Prof Allan Cripps
Address 46558 0
Griffith University
Gold Coast Campus
PVCH (G40 Level 8)
Parklands Drive
Southport
QLD 4222
Country 46558 0
Australia
Phone 46558 0
+6 17 5678 0795
Fax 46558 0
Email 46558 0
allan.cripps@griffith.edu.au
Contact person for public queries
Name 46559 0
Nicholas West
Address 46559 0
Griffith University
Gold Coast Campus
G40_9.17
Parklands Drive
Southport
QLD 4222
Country 46559 0
Australia
Phone 46559 0
+6 17 5678 0899
Fax 46559 0
Email 46559 0
n.west@griffith.edu.au
Contact person for scientific queries
Name 46560 0
Amanda Cox
Address 46560 0
Griffith University
Gold Coast Campus
G40_9.17
Parklands Drive
Southport
QLD 4222
Country 46560 0
Australia
Phone 46560 0
+6 17 5678 0898
Fax 46560 0
Email 46560 0
a.cox@griffith.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.