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Breast Risk Reduction Intermittent Diet Evaluation (BRRIDE) study

The Breast Risk Reduction Intermittent Diet Evaluation (BRRIDE) study: The effect of an intermittent very low calories diet on gene expression in breast cells and surrogate blood markers of risk amongst women at increased risk of breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN77916487
Enrollment
25
Registered
2012-07-31
Start date
2010-02-11
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

25 subjects will be asked to follow a two day IER diet for 1 month which involves a 70% restriction (~600kcal/ day) for 2 days week and ~1850 kcal for 5 days/week. The non very low calorie diet (VLC

Sponsors

University Hospital of South Manchester (UHSM) NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 13, 2026