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

Not Applicable

Completed

• Conditions: bowel cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12612000806864
• Lead Sponsor: Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
If supplementation of 6 Brazil nuts/day increases plasma Selenium (Se) levels<br><br>A blood sample (5mls of whole blood taken on 2 occasions) will be collected at baseline and after intervention, testing for plasma Selenium levels[Blood samples collected at commencement of intervention (week 0) and at end of intervention (wk 4)]

Secondary Outcome Measures

Name	Time	Method
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. <br>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 <br>prevention.<br><br>To assess the results of the Selenium levels after taking the 6 brazil nuts during the intervention period[4 weeks]