A trial looking at diet for women with a family history of breast cancer (BRRIDE2)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is comparing 2 diets to help women who are at an increased risk of breast cancer to lose weight.
We know that being overweight can increase your risk of developing breast cancer. We also know that losing weight can reduce the risk. This trial is part of a programme to find the ideal diet to help people lose weight.
The trial team consider that an ideal diet
- Meets all your nutritional needs but is low enough in calories to help you lose weight
- Is easy to follow
- Helps you lose body fat, including fat from around the vital organs in your tummy (abdomen) but won’t affect your muscles
- Doesn’t affect the amount of calories your body burns each day (your metabolic rate)
In this trial, the researchers are comparing a diet of low calorie healthy eating every day, with an intermittent diet. The intermittent diet is a low 
and low calorie diet for 2 days in a row each week, and a healthy diet for the other 5 days.
The aim of the trial is to compare these 2 diets to find out which might be the ideal diet for women who are at an increased risk of developing breast cancer to lose weight.
Who can enter
You may be able to join this trial if you are a woman going to the Family History Clinic at the Genesis Breast Cancer Prevention Centre, University Hospital of South Manchester and all of the following apply. You
- Have a family history of breast cancer and have more than a 1 in 6 lifetime risk of developing breast cancer yourself (your doctor can tell you this)
- Have a
body mass index (BMI) of 30 to 45 and you have a body fat percentage of at least 40% (the trial team will work this out for you), or your waist is between 88 cm (34½ inches) and 140cm (55 inches) - Do less than 40 minutes of moderate exercise each week
- Are between 30 and 45 years old
- Are still having periods (you haven’t been through the
menopause yet)
You cannot join this trial if any of these apply. You
- Weigh more than 125kg (19½ stone)
- Are a smoker (you may be able to join the trial if you haven’t smoked or used nicotine replacement patches in the last 6 months)
- Are already successfully losing weight or are already on a diet that the trial team thinks may affect you taking part
- Drink more than 21 units of alcohol a week (your doctor will be able to advise you about this) or your doctor has any concerns about the amount of alcohol you drink
- Are depressed or have an eating disorder
- Have (or have had) cancer
- Have any other medical condition or mental health problem that the trial team thinks could affect you taking part
- Have taken certain drugs in the last 6 months (the trial team can advise you about this)
- Can’t have an MRI scan (for example if you have a pacemaker, metal clips or other metal in your body, or can’t be in a confined space)
- Are pregnant or planning to get pregnant in the next 5 months
- Are breastfeeding
Trial design
The trial team need 26 women to join this randomised trial. You are put into a 1 of 2 groups by a computer. You cannot choose which group you are in.
Women in group 1 have a low carbohydrate diet for 2 days in a row each week and a healthy Mediterranean diet for the remaining 5 days.
Women in group 2 have a low calorie healthy Mediterranean diet every day.
The researchers will explain your diet plan to you. The trial lasts for 8 weeks.
You record what you normally eat for a week before starting your diet plan and then continue recording what you eat for the 8 weeks of the trial. You can do this online or in a paper diary.
The trial team will ask you to fill out a questionnaire about your physical activity before you start your diet, at week 4 and week 8.
Hospital visits
You have an MRI scan at the start of the trial. You have it early in the morning at the Wolfson Centre. You cannot eat or drink anything (apart from water) after the meal you have the evening before. When you have the scan, you need to lie still for up to 45 minutes and you will be asked to hold your breath for periods of 10 seconds.
On the same day, you have a test that measures how your body reacts to sugar at the endocrine clinic at the Christie Hospital. This is a short walk away from the Wolfson Centre. This visit will take 5 hours in total.
A researcher will put a small plastic tube (cannula) into a vein in your arm. They will take 3 blood samples over 10 minutes. After this, you have a drink with a lot of sugar in it. The researcher will then take a blood sample every 30 minutes for 3 hours.
After your scan and the sugar test, the hospital will give you a complimentary meal at the hospital restaurant.
On another day later the same week, a member of the trial team at the Genesis Breast Cancer Prevention Centre will measure your weight, waist, hips and bust. The trial team will also do a test to measure the amount of calories your body uses (your metabolic rate). To do this you lie down in a room underneath a hood for 15 minutes. You cannot eat for 5 hours before having this test. This visit takes 2½ hours. You have the metabolic rate test and the measurements done again in week 8.
You have another MRI scan, and sugar test in week 7 and week 8.
Every 2 weeks you see the dietician at the Genesis Breast Cancer Prevention Centre. They will phone you during the week between each visit to see how you are going.
Side effects
Both the diet plans are safe and meet your nutritional needs.
We have more information about having an MRI scan.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Michelle Harvie
Supported by
Genesis Breast Cancer Prevention Appeal Ltd
NIHR Clinical Research Network: Cancer
Pancreatic Cancer UK
University Hospital of South Manchester (UHSM)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
