Dataset Information

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

ABSTRACT: 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 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 Primary outcome(s): 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[Blood samples collected at commencement of intervention (week 0) and at end of intervention (wk 4)] Study Design: Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety

DISEASE(S): Bowel Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2458510 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: 30 healthy volunteers (>50yrs) at-risk for CRC by virtue of age and /or other standard risk factors will be recruited to participate in a randomised, three cohort dietary intervention study. with a parallel design to test the effects of Se and green tea alone and in combination on molecular biomarkers for CRC prevention in the normal rectal epithelial cells. They will be instructed to maintain their usual diet during the study but to avoid supplementation with any green tea-related food or drink (limited to <3 cups of black tea per day), and Se-rich foods such as octopus, crab and tuna, liver and kidney or additional Brazil nuts or other nuts (except those Brazil nuts and green tea extract prescribed by us). The study will consist of dietary intervention period of 6 weeks, preceded by a run in period of 4 weeks. The volunteers will be randomised (randomisation will be computer generated) into one of three groups of 10, receiving 1) Se, supplied as Brazil nuts (6 Brazil nuts daily will provide 48micrograms Se/day); 2) Green tea, supplied as a green tea extract capsule (4 capsules daily will provide 800mg EGCG/day); and 3) Se + green tea (6 Brazil nuts daily + 4 green tea extract capsules daily (will provide 48micrograms Se/day and 800mg EGCG/day). Six Brazil nuts has been chosen because the average Se concentration (2.7 micrograms Se/g) in Brazil nuts (supplied from Charlesworth, Australia) is relatively low compared to that of the report by Thomson et al, where the Se concentration is 6.4micrograms Se/g, and average weight for one nut is 4g, 2 nuts provided 53 micrograms Se/day (Am J Clin Nutr 2008;87:379-3840). Since the average weight of one Brazil nut (supplied from Charlesworth, Australia) is 3g, 6 Brazil nuts daily will provide 48microgra Primary outcome(s): Effects of combination diet (Se + green tea) on biomarkers of Wnt pathway (catenin), inflammation (COX-2) and DNA repair (MGMT) in rectal epithelium. Rectal biopsies will be collected and examined by RT-PCR and immunohistochemistry for the expression of these biomarkers at gene and protein levels[Commencement of Intervention (Baseline), End of intervention (6 weeks) ] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

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

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