Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Family history of breast cancer (lifetime risk >1 in 6) 2. Body mass index 24?35 kg/ m2 3. Aged between 35 and 45 years 2. Regular menstrual cycles (not perimenopausal). 3. Breast density >30% determined by mammogram (to ensure epithelium is obtained in core biopsy) 5. Sedentary (<20 minutes moderate activity twice/ week) to avoid any confounding effects of exercise 6. Able to record diet diaries 7. Normal mammogram in the last 2 years
Exclusion criteria
Exclusion criteria: 1. Already successfully dieting or losing weight 2. Long term medical condition which may affect white cell function; i.e. autoimmune, inflammatory, allergy 3. Consumption of diets or supplements high in phytoestrogens 4. Previous use of tamoxifen or other selective oestrogen receptor modulators 5. Current use of anticoagulant or anti-platelet drugs including regular aspirin 6. Previous diagnosis of breast cancer or other cancers except non-melanoma skin cancer or cervical intra-epithelial neoplasia 7. Previous atypical ductal hyperplasia or Atypical Lobular Hyperplasia 8. Pregnant or planning a pregnancy in the next few months 9. Irregular menstrual cycles with the possibility of perimenopausal status 10. Use of hormonal oral contraceptives or progesterone only contraceptives (Intra-uterine system (?Mirena?), injectable or implantable progesterones) currently or in the past 6 months. 11. Serious co-morbidity that would in the opinion of the investigator confound the results of the study or put the patient at risk, such as diabetes mellitus, ischaemic heart disease, thyroid disease 12. Psychiatric morbidity (eating disorders, depression or alcoholism) 13. Previous breast enhancement or breast reduction surgery 14. Received inoculations or donated blood within 2 months of the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression of genes which produce the fat synthesis protein (Stearoyl-CoA desaturase) in breast cells of women after 1 month of a 2 day/week very low calorie diet. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Expression of 19 other proteins which process fat and carbohydrate in breast tissue and may be linked to breast cancer risk 2. Expression of proteins which process fat and carbohydrate in white blood cells 3. Hormones, proteins and fats and other products of metabolism in blood and urine | — |
Countries
United Kingdom