Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000806864
Enrollment
4
Registered
2012-08-01
Start date
2012-08-16
Completion date
2012-09-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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

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

Sponsors

Flinders Medical Centre
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years
Healthy volunteers
Yes

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026