Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000276257
Ethics application status
Approved
Date submitted
13/02/2018
Date registered
22/02/2018
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparative randomised double blind study to evaluate the effect of Lutein supplementation on Macular Pigment Optical Density (MPOD) and blood Lutein levels in healthy adults over 16 weeks.
Scientific title
A comparative randomised double blind study to evaluate the effect of Lutein supplementation on Macular Pigment Optical Density (MPOD) and blood Lutein levels in healthy adults over 16 weeks.
Secondary ID [1] 293470 0
PHK-LUT18
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
eye health - Macular Pigment Optical Density (MPOD) 305661 0
Condition category
Condition code
Eye 304883 304883 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A. Standard FloraGLO Lutein 20mg / day – Proprietary Ingredient ID 12948
B. AquaCelle FloraGLO Lutein 5mg / day – ARTG L 277981
Randomisation 1:1

The investigational products are to be taken at breakfast time with water.

Approximately 62 adult male and female participants aged between 20 and 45 years will be recruited from
databases and public media outlets. Following preliminary screening via telephone, if eligible, potential participants
will attend the clinic for an information session and will be requested to provide their consent for inclusion in the
trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications,
weight and height assessment and medical history; this data will be used for the comprehensive screening and to
provide contextual data for the study. Blood lutein concentration will also be measured.
Participants will be given a list of foods to avoid during the study period. Participants will also
complete a food diary at baseline, week 8 and 16.
The specific foods participants must avoid during the study are:
• Spinach, kale, chard, collard greens, mustard greens, lettuce, spring onions, broccoli
• Coriander, basil, parsley
• Pistachio nuts
• More than 3 eggs per week
Participants will take the allocated product daily for 16 weeks and undertaken the same baseline
measures at weeks 4, 8, 12 and 16.
Macular Pigment Optical Density (MPOD) will be measured by the MPS II Macular Pigment Screener
(Elecktron Technology) (MPS II). MPS II is a computerised instrument for measuring MPOD. The
MPS II emits low intensity light of specific wavelengths at calibrated intensities. The test subject is
asked to look into the instrument at the stimulus light and asked to press a button when a light flicker
appears.
Intervention code [1] 299716 0
Treatment: Other
Comparator / control treatment
Standard FloraGLO Lutein
Control group
Active

Outcomes
Primary outcome [1] 304074 0
Macular Pigment Optical Density (MPOD) as measured by the MPSII Macular Lutein Pigment Screener
Timepoint [1] 304074 0
Baseline, week 4, 8, 12 and 16 (primary timepoint)
Secondary outcome [1] 340858 0
Blood Lutein concentration (plasma / serum)
Timepoint [1] 340858 0
Baseline, weeks 4, 8, 12 and 16
Secondary outcome [2] 340859 0
Gastrointestinal tolerance as measured using the Gastrointestinal tolerance questionnaire
Timepoint [2] 340859 0
Baseline, week 4, 8, 12 and 16
Secondary outcome [3] 343097 0
Food intake measured by food diary
Timepoint [3] 343097 0
Baseline, weeks 8 and 16
Secondary outcome [4] 343098 0
Weight and height to be used to calculate BMI
Timepoint [4] 343098 0
Baseline, weeks 4, 8, 12 and 16

Eligibility
Key inclusion criteria
• Men and women between the ages of 20 and 45 years
• Non-smoker (for 1 year)
• BMI 18.5-30.0
• No chronic diseases or gastrointestinal disturbances
• No prescription or over-the-counter drugs during the study (except oral contraceptive pill OCP), or vitamin or mineral supplements containing carotenoids/B-Carotene
• Agree to maintain current dietary habits throughout the duration of the study.
• MPOD values between 0.1-0.3
• No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haemotogical abnormalities that are uncontrolled.
• Participant’s full agreement and ability to consent to participation in the study
• Participant’s ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points.
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• A regular consumer (greater or equal to 2 servings/week) of lutein rich foods or lutein supplements
• Uncontrolled hypertension (>140/90 mm Hg)
• Diabetes mellitus
• Pregnancy (or planning to become pregnant) or lactation
• Diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn’s disease, cystic fibrosis
• Eye conditions, cataracts, glaucoma
• Reported participation in another trial 3 months before the start of the study
• Recent history (within 12 months) of substance abuse including alcohol
• Current smoker

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)
The potential participants are screened by the investigator for inclusion in the study. The eligible participants are enrolled by investigator and provided with a "Numbered Container" that is identical to all other containers and contains the same information on the label, except for the number. The investigator is blinded to the product randomized with the
numbered containers labelled prior to delivery to investigational site. Product allocated as participants are enrolled in sequential order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomized software
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298094 0
Commercial sector/Industry
Name [1] 298094 0
Pharmako Biotechnologies Pty Ltd
Country [1] 298094 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street
Newstead, QLD, 4006
Country
Australia
Secondary sponsor category [1] 297171 0
Commercial sector/Industry
Name [1] 297171 0
Pharmako Biotechnologies Pty Ltd
Address [1] 297171 0
36 Campbell Ave Cromer, NSW, AUS, 2099
Country [1] 297171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299114 0
Bellberry Ltd
Ethics committee address [1] 299114 0
Ethics committee country [1] 299114 0
Australia
Date submitted for ethics approval [1] 299114 0
03/11/2017
Approval date [1] 299114 0
22/12/2017
Ethics approval number [1] 299114 0

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

Contacts
Principal investigator
Name 79338 0
Dr David Briskey
Address 79338 0
RDC GLOBAL Pty Ltd
3B/76 Doggett St, Newstead, QLD 4006
Country 79338 0
Australia
Phone 79338 0
+61 421 784 077
Fax 79338 0
Email 79338 0
[email protected]
Contact person for public queries
Name 79339 0
Amanda Rao
Address 79339 0
RDC GLOBAL Pty Ltd
3B/76 Doggett St, Newstead, QLD 4006
Country 79339 0
Australia
Phone 79339 0
+61 414 488 559
Fax 79339 0
Email 79339 0
[email protected]
Contact person for scientific queries
Name 79340 0
Amanda Rao
Address 79340 0
RDC GLOBAL Pty Ltd
3B/76 Doggett St, Newstead, QLD 4006
Country 79340 0
Australia
Phone 79340 0
+61 414 488 559
Fax 79340 0
Email 79340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
136Ethical approval    374070-(Uploaded-06-11-2018-14-33-28)-Study-related document.pdf



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.