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BRRIDE 2 - Breast Risk Reduction Intermittent Diet Evaluatio

Not Applicable
Completed
Conditions
Topic: Cancer
Subtopic: Breast Cancer
Disease: Breast
Cancer
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
Inclusion Criteria

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)

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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