Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001092684
Ethics application status
Approved
Date submitted
4/10/2014
Date registered
14/10/2014
Date last updated
14/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to assess the effect of Brazil nuts on plasma selenium levels in healthy male volunteers aged 65 years and over
Scientific title
Pilot study to assess the effect of Brazil nuts on plasma selenium levels in 30 healthy male volunteers aged 65 years and over
Secondary ID [1] 285415 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy male volunteers aged 65 years and older. The health condition for which the intervention may be indicated is prostate cancer. 293162 0
Condition category
Condition code
Cancer 293435 293435 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a dose ranging feasibility study. Participants will be assigned to 1 of 3 groups and asked to consume 2, 5 or 10 Brazil nuts, daily for 30 days. At baseline volunteers wil complete a questionnaire on dietary habits, supplement use, and demographic details. Height will be measured at baseline and weight will be measured at baseline and endpoint. Volunteers will be asked to avoid selenium enriched foods (e.g. fish, liver, kidney, and additional Brazil nuts) during the study period, but otherwise they will be asked to continue eating as normal. A 24-hour dietary recall and food frequency questionnaire will be used to verify the types of foods consumed at baseline and endpoint of the study period. Confounding factors will be accounted for.
The Brazil nut (Bertholletia excelsa) is the best source of selenium, a trace element and mineral that is nutritionally essential for human health. Concentration varies between 8 and 83 micrograms/g. Brazil nuts provide a rich natural source of selenium, however limited studies have investigated the bioavailability of selenium in humans.
This pilot study will aid to inform a second pilot study. Pilot study 2 will be in men with advanced prostate cancer (n=20). The study timeframe and Brazil nut dosage will be determined from pilot study 1. The objective is to look at biomarkers of progression observed in prostate cancer. Pilot study 2 will be registered with ANZCTR in the near future.
Intervention code [1] 290332 0
Other interventions
Comparator / control treatment
The three different dose groups are being compared, i.e. 2 vs. 5 vs. 10 Brazil nuts daily for 30 days
Control group
Dose comparison

Outcomes
Primary outcome [1] 293259 0
The change in mean selenium response from baseline to 30 days
Timepoint [1] 293259 0
A blood sample (60 mL of whole blood) will be collected on 3 occasions: at baseline (day 0), midpoint (day 15) and endpoint (day 30) of the intervention. Plasma selenium levels will be assessed.
Secondary outcome [1] 310688 0
Nutritional biomarkers: plasma and whole blood GPx
Timepoint [1] 310688 0
The primary outcome blood sample will also be used to measure the secondary outcomes. A blood sample (60 mL of whole blood) will be collected on 3 occasions: at baseline (day 0), midpoint (day 15) and endpoint (day 30) of the intervention.
Secondary outcome [2] 310827 0
Selenoprotein P
Timepoint [2] 310827 0
The primary outcome blood sample will also be used to measure the secondary outcomes. A blood sample (60 mL of whole blood) will be collected on 3 occasions: at baseline (day 0), midpoint (day 15) and endpoint (day 30) of the intervention.
Secondary outcome [3] 310828 0
Inflammatory marker: C-reactive protein (CRP)
Timepoint [3] 310828 0
The primary outcome blood sample will also be used to measure the secondary outcomes. A blood sample (60 mL of whole blood) will be collected on 3 occasions: at baseline (day 0), midpoint (day 15) and endpoint (day 30) of the intervention.

Eligibility
Key inclusion criteria
Eligible participants include healthy, non-smoking men aged 65 years and older
Minimum age
65 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Ineligible participants include the presence of nut-allergies and the regular use of a selenium supplement and not willing to discontinue use during the research study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The subjects will be studied consecutively and allocated to one of the three arms in a non-randomised fashion. The first 10 volunteers (Group 1) will receive 2 Brazil nuts daily for 30 days, the following 10 volunteers (Group 2) will receive 5 Brazil nuts daily for 30 days and the last group of 10 volunteers (Group 3) will receive 10 Brazil nuts daily for 30 days.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The statistical methods used for the study objectives/hypotheses (e.g. t-test, chi-squared, multivariate modelling) will be sufficiently detailed. A statistician will be consulted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290020 0
Charities/Societies/Foundations
Name [1] 290020 0
Clinical Oncological Society of Australia (COSA)
Funded under the ImoGEX-PC-LycTM Grant
Country [1] 290020 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Centre for Dietetics Research (C-DIET-R)
School of Human Movement Studies (B#26)
Cnr Blair Drive and Union Road
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 288708 0
None
Name [1] 288708 0
Address [1] 288708 0
Country [1] 288708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291727 0
The University of Queensland Institutional Human Research Ethics Approval
Ethics committee address [1] 291727 0
The University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 291727 0
Australia
Date submitted for ethics approval [1] 291727 0
Approval date [1] 291727 0
21/08/2014
Ethics approval number [1] 291727 0
2014000872

Summary
Brief summary
The purpose of this study is to investigate the efficacy of Brazil nuts in increasing selenium status in healthy males aged 65 years and older, as this is the average age of prostate cancer diagnosis in Australia.

Who is it for?
You may be eligible to join this study if you are a healthy, non-smoking male aged 65 years or older, who does not have any nut allergies, and does not regularly use a selenium supplement.

Study design:
Participants in this study will be assigned to 1 of 3 groups and asked to consume 2, 5, or 10 Brazil nuts daily for 30 days. At baseline volunteers will complete a questionnaire on dietary habits, supplement use, and demographic details. Height and weight will also be measured. Volunteers will be asked to avoid selenium enriched foods (e.g. fish, liver, kidney, and additional Brazil nuts) during the study period, but otherwise they will be asked to continue eating as normal. A 24-hour dietary recall and food frequency questionnaire will be used to verify the types of foods consumed at baseline and endpoint of the study period. Participants will also be required to give blood samples at the end of the 30 day study period in order to evaluate blood levels of selenium and other nutritional markers.

The Brazil nut (Bertholletia excelsa) is the best source of selenium, a trace element and mineral that is nutritionally essential for human health. This antioxidant is the focus of significant recent research in prostate cancer, as it is proposed that selenium may reduce tumour growth and cancer progression. The data from this study will be explored to inform future nutrition intervention studies in men with advanced prostate cancer.
Trial website
TBA
Trial related presentations / publications
Nil at present
Public notes

Contacts
Principal investigator
Name 51762 0
Mrs Vanessa Getliffe
Address 51762 0
PhD Candidate
Centre for Dietetics Research (C-DIET-R)
School of Human Movement Studies (26B)
The University of Queensland
Cnr Blair Drive and Union Road
St Lucia Qld 4072
Country 51762 0
Australia
Phone 51762 0
(+61) 7 3365 6669
Fax 51762 0
(+61) 7 3365 6877
Email 51762 0
v.getliffe@uq.edu.au
Contact person for public queries
Name 51763 0
Mrs Vanessa Getliffe
Address 51763 0
PhD Candidate
Centre for Dietetics Research (C-DIET-R)
School of Human Movement Studies (26B)
The University of Queensland
Cnr Blair Drive and Union Road
St Lucia Qld 4072
Country 51763 0
Australia
Phone 51763 0
(+61) 7 3365 6669
Fax 51763 0
(+61) 7 3365 6877
Email 51763 0
v.getliffe@uq.edu.au
Contact person for scientific queries
Name 51764 0
Dr Olivia Wright
Address 51764 0
The University of Queesland
School of Human Movement Studies building (26B)
Room 407, Level 4
St Lucia Qld 4072
Country 51764 0
Australia
Phone 51764 0
(+61) 7 3365 6669
Fax 51764 0
(+61) 7 3365 6877
Email 51764 0
o.wright@uq.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

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