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Pilot study to assess the effect of Brazil nuts on plasma selenium levels in healthy male volunteers aged 65 years and over

Pilot study to assess the effect of Brazil nuts on plasma selenium levels in 30 healthy male volunteers aged 65 years and over

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614001092684
Enrollment
30
Registered
2014-10-14
Start date
2014-11-03
Completion date
Unknown
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

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.

Interventions

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 oth

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.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Eligible participants include healthy, non-smoking men aged 65 years and older

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026