BRRIDE 2 - Breast Risk Reduction Intermittent Diet Evaluation

ISRCTN	ISRCTN10803394
DOI	https://doi.org/10.1186/ISRCTN10803394
Secondary identifying numbers	18052

Submission date: 08/01/2015
Registration date: 12/01/2015
Last edited: 20/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/trials/a-trial-looking-diet-women-family-history-breast-cancer-brride2

Contact information

Dr Michelle Harvie
Scientific

University Hospital of south Manchester
Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Study information

Study design	Randomised; Interventional
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of the effect of intermittent energy restriction (IER) versus daily energy restriction (DER) on body fat stores and blood markers of cancer risk.
Study acronym	BRRIDE 2
Study hypothesis	Hypothesis: Excess fat is important in the risk and development of breast cancer. Fat stored within the liver has an effect on the control of blood sugar levels (insulin resistance)this is an important mediator of breast cancer risk. Excess fat also causes changes in sex hormone levels, and chronic inflammation that are important in breast cancer risk. Calorie restricted diets cause reductions in liver and abdominal fat and reduced insulin resistance and hence reduced cancer risk. Intermittent dieting is an increasingly popular method of dieting (2 day diet book, Harvie & Howell, Fast diet, Mosely & Spencer) which involves short spells of severe restriction and spells of normal intake. We have shown that intermittent dieting leads to a greater reduction in insulin resistance than daily dieting with comparable weight loss. We hypothesise that an intermittent energy restricted diet will lead to a greater reduction in liver fat compared to a daily energy restricted diet. This study will define the effects of intermittent compared to standard daily dieting on markers of cancer risk (insulin resistance, markers of inflammation) and inform the value of intermittent energy restriction as a potential cancer risk reduction strategy.
Ethics approval(s)	NRES Committee South Central - Oxford B, 20/08/2015, ref: 14/SC/1097
Condition	Topic: Cancer; Subtopic: Breast Cancer; Disease: Breast
Intervention	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 high fibre carbohydrates and allows up to 10 units of alcohol per week 2. Intermittent energy restriction, a low carbohydrate energy restricted diet (600 kcal, <50g carbohydrate, 50 g protein day) for two consecutive days followed by an ~1900 kcal mediterranean type diet for the remaining five days of the week. Each of the two low carbohydrate 600 kcal energy restricted days includes; ~ 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
Intervention type	Other
Primary outcome measure	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 outcome measures	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.
Overall study start date	05/01/2015
Overall study end date	30/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 26; UK Sample Size: 26
Participant 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)
Participant 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
Recruitment start date	05/01/2015
Recruitment end date	30/06/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospital of south Manchester

Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor information

University Hospital of South Manchester NHS Foundation Trust
Hospital/treatment centre

Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom

"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

Genesis Breast Cancer Prevention Appeal Ltd (UK)

No information available

Pancreatic Cancer UK

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	To be confirmed at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

20/08/2020: The intention to publish date has been added.
08/08/2017: No publications found in PubMed, verifying study status with principal investigator.