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Trial registered on ANZCTR

Registration number

ACTRN12612000806864

Ethics application status

Approved

Date submitted

30/07/2012

Date registered

1/08/2012

Date last updated

14/07/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Pilot study to assess the effect of Brazil nuts on plasma selenium levels

Scientific title

Pilot study to assess the effect of Brazil nuts on plasma selenium levels in four healthy participants over 25 years of age

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

bowel cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will take 6 brazil nuts a day for four weeks.
This four week intervention will be preceded by a 4 week run-in / wash out phase
participants will be advised to exclude any selenium rich foods or green tea during the study

This Pilot study will confirm the amount of Brazil Nuts we will use in the study comparing with green tea. This follow up study (Effects of combining Selenium (Se) and green tea on biomarkers for colorectal cancer prevention in human subjects). will be registered with ANZCTR in the near future'

At the initial interview dietary advice will be given. This will give an understanding of the nature of the volunteers diet and the likely influence of Se to the diet and suitability to become involved in the study
(if intolerant to nuts volunteers will not participate in the study)
We will ask participants not to consume, whenever possible, throughout the study:-
Any selenium supplement
Any selenium enriched foods, such as nuts, sea food (such as tuna or octopus)

The Brazil nut is a large nut that comes from the castanheiro de para tree in Brazil's rainforests. Each serving of about six to eight nuts contains 4 g of protein and 7 grams each of monosaturated and polysaturated fat.
Brazil nuts (Berholletia excelas, family Lecythidaceae) are the richest known food source of selenium, with mean concentrations reported in the literature between 8-83 micrograms Se/g
6 Brazil nuts daily provides 48 micrograms Se/day - 53 micrograms Se/day

Intervention code [1]

Prevention

Comparator / control treatment

not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

If supplementation of 6 Brazil nuts/day increases plasma Selenium (Se) levels

A blood sample (5mls of whole blood taken on 2 occasions) will be collected at baseline and after intervention, testing for plasma Selenium levels

Timepoint [1]

Blood samples collected at commencement of intervention (week 0) and at end of intervention (wk 4)

Secondary outcome [1]

The results generated from this pilot study will help determine if 6 Brazil nuts daily is feasible for human consumption, and if this dose of Brazil nuts significanly increases plasma Se levels.
If so, we will conduct the human intenvention study to determine if a combination of Brazil nuts with green tea extract will benefit human health, including colon cancer
prevention.

To assess the results of the Selenium levels after taking the 6 brazil nuts during the intervention period

Timepoint [1]

4 weeks

Eligibility

Key inclusion criteria

Healthy, with no active bowel disease, or
With no previous history of adenoma removal
With plasma Se at or below 106 micro g/dL. (to ensure that people with a high background Se status for whatever reason are not included in the study)

Minimum age

25 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Evidence of any active mucosal bowel disease, eg colitis, or of malabsorption
Previous bowel surgery (excluding polypectomy)
Any allergy or intolerance to nuts

Study design

Purpose of the study

Prevention

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

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/08/2012

Actual

16/08/2012

Date of last participant enrolment

Anticipated

13/09/2012

Actual

13/09/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

1 Flinders Drive
Bedford Park
5042
South Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee.

Ethics committee address [1]

Flinders Medical Centre,
Flinders Drive
Bedford Park 
SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/06/2012

Approval date [1]

17/07/2012

Ethics approval number [1]

1/12/0278

Summary

Brief summary

Selenium (Se) - an essential trace micronutrient, and green tea - the most common beverage consumed worldwide, have numerous biological properties that may protect against various cancers, including colorectal cancer (CRC). Despite promising results in preclinical settings, current clinical trial data are not convincing enough to allow general recommendation for using Se or green tea as an effective agent for chemoprevention of cancer in humans. 

This is a pilot study on the possible effects of Selenium (Se) in preventing bowel cancer in healthy individuals. 3 or 4 of our staff members will take part in this trial, prior to the launch of a full study once results have been gathered from this pilot study. 

Who is it for? 

This pilot study on Brazil nuts will be performed on 3 or 4 of our staff. They will take 6 Brazil nuts daily (which will provide 48 micrograms Se/day) for 4 weeks. Their blood samples (on 2 occasions) will be collected at the baseline and after intervention. We believe this pilot study will provide important information as to how many Brazil nuts will be required per day to increase plasma Se levels, as we expand the research into an upcoming, full study.

Background Information

There is growing evidence that a combination of dietary agents may synergistically or additively improve the chemopreventive efficacy than any single dietary agent. Our previous studies in mouse CRC model have shown that Se activate apoptosis (Cancer Res. 2008 June 15;68(12):4938-44), whereas green tea up-regulates DNA repair enzyme. Our recent animal studies have further shown that combining Se and green tea is more effective in suppressing colorectal oncogenesis than either Se or green tea alone, and is associated with regulation of genetic and epigenetic biomarkers implicated in colonic carcinogenesis (submitted to Clinical Cancer Research). 

Se and green tea are particularly interesting as a combination not only because they can be co-administered in the diet but also because they have potentially complementary mechanisms of action. We now plan to expand our study to human subjects and determine if a combination dietary supplementation of Se and green tea provides greater health benefits than can be achieved from a single dietary agent of Se or green tea by regulating molecular biomarkers. 

We have used selenium-enriched milk protein as the Se source in our previous human trials (Br J Nutr 2011 Aug;106(4):572-82). It was our intention to continue using dairy Se product for our upcoming human trial. Unfortunately, the production and supply of selenium-enriched milk protein has been stopped by Tatura Milk Industries (VIC, Australia). We have to seek an alternative Se source from food, and have decided to use Brazil nuts because it is the richest known food source of Se. A previous randomized controlled human trial has shown that 2 Brazil nuts per day (provided 53micrograms Se/day) is as effective for increasing plasma Se status as 100 micrograms Seasselenomethionine during 12 weeks of intervention, reaching maximum plasma Se levels at 6 weeks (Am J ClinNutr 2008;87:379-3840). Se concentration in Brazil nuts (supplied from Charlesworth, Australia) has recently been analysed by National Measurement Institute (Australia Government, VIC), the average Se concentration in Brazil nuts is relatively low (2.7 micrograms Se/g) compared to that of the report by Thomson et al, where the Se concentration is 6.4 micrograms Se/g (Am J ClinNutr 2008;87:379-3840).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Graeme Young

Address

Flinders Centre for Innovation in Cancer
Flinders University
Bedford Park SA

Country

Australia

Phone

+61 8 8404 2841

Fax

[email protected]

Contact person for public queries

Name

Jane Upton

Address

Department of Gastroenterology
Flinders Medical Centre
1 Flinders Drive
Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82046071

Fax

61 8 82046330

[email protected]

Contact person for scientific queries

Name

Dr Ying HU

Address

Department of Gastroenterology
Flinders Medical Centre
1 Flinders Drive
Bedford Park
SA 5042

Country

Australia

Phone

+61 8 82045170

Fax

[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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Documents added automatically

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