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A study exploring the potential of selenium incorporated in dairy proteins to improve health and reduce the risk of colon cancer.

ABSTRACT: Interventions: The aim is to explore the potential of selenium incorporated in dairy proteins to improve bowel health and reduce the risk of colon cancer. Participants will include a special dairy product in their diet in which the dairy proteins have been naturally enriched with selenium. High selenium=100 micrograms per day, Placebo =1.5 micrograms selenium per day, in Milk protein concentrate prepared as a powdered food drink. Each intervention is 8 weeks in length with a 2 week wash-out between each phase. Markers of the health value of selenium will then be examined in samples of blood and samples taken from the lining of the bowel wall. The duration of the intervention will be 2 weeks baseline+ 8 weeks for each treatment phase (16wks) and 2 weeks wash out between treatment phases. Primary outcome(s): Level of plasma glutathione peroxidase (GSPx) taken at the beginning and end of each intervention[At the beginning and end of each treatment (Week 0 and week 8).] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Bio-availability

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

PROVIDER: 2452132 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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

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A study exploring the potential of selenium incorporated in dairy proteins to improve health and reduce the risk of colon cancer.

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