BRRIDE 2 - Breast Risk Reduction Intermittent Diet Evaluatio
- Conditions
- Topic: CancerSubtopic: Breast CancerDisease: BreastCancer
- Registration Number
- ISRCTN10803394
- Lead Sponsor
- niversity Hospital of South Manchester NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 26
1. Family history of breast cancer (lifetime risk >1 in 6)
2. Premenopausal aged >30-45 years
3. Body mass index 30-45 kg/m2.
4. Nonsmoker
5. Sedentary (< 40 minutes moderate exercise per week)
1. Contradindication to MR imaging (e.g pacemaker, weight greater than 125kg)
2. Already successfully losing weight.
3. Pregnant or planning pregnancy over next 5 months
4. Currently Breast feeding
5. Eating disorder, depression or alcoholism
6. Alcohol intake greater than 10g of ethanol (10 units) per week
7. Comorbidity that affects liver fat stores i.e. NonAlcoholic Fatty Liver Disease, diabetes, viral hepatitis, fibrosis, Human Immunodeficiency Virus, coeliac disease
8. Drug use current or within the past 6 months affecting liver fat content i.e. insulin, oral contraceptives, tamoxifen, statins, amiodarone, methotrexate, corticosteroids
9. Previous or current history of cancer
10. Following an incompatible therapeutic diet
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method