Improving health in breast cancer survivors, a novel dietary approach

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Dietary education will occur monthly for 6 months at the Clinical Research Centre in Grafton (85 Park Road, Grafton). Both BC‐Med and Healthy Diet intervention will receive education (conducted by a Registered Dietitian and Dietetic student) and newsletters (sent by email). Face‐to‐face group education will occur once‐monthly, with the newsletter sent two weeks thereafter. Questionnaires will be administered and bloods taken at baseline, at completion of intervention (6 months) and 6 months post intervention (12 months). Body weight, a blood test and questionnaires will be measured at baseline, post intervention and follow‐up. Participants will be placed into one of three arms of a dietary intervention study. Each arm will consist of 15 women. Women on Arm 1 will be asked to adhere to a BC‐MED diet and will receive dietary support and education. The BC‐Med diet will consist of increasing the intake of olive oil, flaxseed oil, vegetables, fruit, legumes, fish, nuts, onions, leeks, garlic and turmeric while limiting the intake of red meat, butter, margarine, cream, carbonated drinks and pastries. The treatment diet will not restrict food volumes, just alter food types. Those placed in Arm 2 will be asked to adhere to a New Zealand healthy eating diet and will receive dietary support and education. The healthy eating diet will follow guidelines from the Nutrition Guidelines and will advocate fruit and vegetable consumption, low fat dairy, low fat meat, wholegrains and adequate hydration. The treatment diet will not restrict food volumes. An educational newsletter will be provided to the BC‐MED and healthy eating groups once a month during the intervention. The intervention period will be 6 months. Changes in gene expression levels will be calculated and used to determine the pathways and networks affected by the change in dietary intake. Study participants will be genotyped in order to account for some of the risk associated with hereditary factors and differences in response to the diet. Diet adherance will be determined via attendance at education sessions, and on analysis of the food diaries completed mid way through the intervention, and change in PREDIMED questionnaire. Participants in each group will be matched for receptor expression and histology, breast cancer grade and use of hormone therapy. Research will be conducted at the Clinical Research Centre at Grafton campus of The University of Auckland. CONDITION: Breast Cancer PRIMARY OUTCOME: Blood lipids (LDL‐chol, Total cholesterol). HbA1c (whole blood), assessed using ion exchange chromotography Weight. Measured on calibrated, ISAK accredited body weight scales in the clinical centre by an ISAK accredited anthropometrist. SECONDARY OUTCOME: C‐RP (serum sample) DNA damage (The comet assay) Dietary intake questionnaire (PREDIMED) Fatty acid profile (FAMES assay) Quality of life questionnaire (FACT‐B) INCLUSION CRITERIA: Those aged 50 or above, diagnosed with grade 1‐3 breast cancer and three or more months following active treatment and a body mass index (BMI) >25 will be enrolled. Participants can be on hormonal therapy. Participants will need to provide medical information regarding their breast cancer grade. We request participants provide receptor expression and use of hormone therapy, but those who wish to keep this information private will still be eligible.
Epistemonikos ID: 1d7a4c24bc7093dd4279180c57d7dd793c4bc5ae
First added on: Aug 25, 2024