Topic: Cancer
Conditions
Interventions
1. Daily energy restriction, A daily 25% energy restricted Mediterranean diet (~1500kcal/day) for seven days/week which includes healthy fats, protein foods, low fat dairy, fruit and vegetables and hi
~ 300g of lean protein foods e.g. lean meat, fish, eggs, tofu, quorn, textured vegetable protein, three portions of low fat dairy foods, five portions of low carbohydrate vegetables
one portion of low carbohydrate
Sponsors
University Hospital of South Manchester NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Image determined hepatic fat fraction and lipid types (MRS) 2. Insulin resistance using modelling of insulin, glucose and Cpeptide measurements during an Oral Glucose Tolerance Test (OGTT) All measured at baseline and after following diet for 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body mass and composition: total body fat, visceral and subcutaneous fat (MRS). 2. Intramyocellular fat fraction (MRS) a predictor of systemic insulin resistance 3. Pancreatic fat fraction and lipid types (MRS) 4. L3 skeletal muscle area using MR imaging – an indicator of sarcopenia and lean body mass 5. Markers of breast cancer risk. Inflammatory markers; IL6, adipokines: fasting adiponectin and leptin, IGF1 6. Fasting lipid profile. i.e. total low density lipoprotein (LDL) and high density lipoprotein (HDL) and triglceride linked to risk of breast cancer44 and cardiovascular disease 7. Resting energy expenditure (Fitmate GS portable desktop indirect calorimeter (Cosmed, Rome Italy) . We will also assess simple clinic body fat and fat free mass (bioelectrical impedence;Tanita 180) and anthropometric measurements (waist, hip and bust circumference) All measured at baseline and after following diet for 8 weeks. | — |
Countries
England, United Kingdom
Outcome results
None listed