Plain English Summary
Background and study aims
Obesity is a significant health concern and is associated with an increased risk of developing certain types of cancer. However, less is known about how obesity and cancer are linked, and there is little evidence that standard dietary methods of weight loss reduce cancer risk. The aim of this study is to explore the effects of diet-induced weight loss on biomarkers for colorectal cancer risk.
Who can participate?
Men and women, aged 18-60, non-smokers, fluent in English, with body mass index BMI ≥30
What does the study involve?
Participants attend weekly sessions with a Psychologist/Dietitian at University College London where they receive a complete meal replacement plan and support. Participants are asked to have a flexible sigmoidoscopy (a procedure used to see inside the sigmoid colon and rectum) to obtain colon tissue samples from their colon at baseline and follow-up (8 weeks). At the start of the study and after 8 weeks, participants complete a questionnaire on psychological wellbeing and eating habits, have a blood test, and have their body measurements taken (height, weight, body fat, waist and hip circumference).
What are the possible benefits and risks of participating?
If the diet is adhered to, participants will lose weight and they should benefit from the effects of weight loss. In addition, they will be provided with the tools to manage their lifestyle in the longer term to help them successfully maintain the weight loss. Participants will be under the care of a specialist in obesity medicine while on the meal replacement programme. As with all medical procedures there are risks involved, however they are small. The flexible sigmoidoscopy will be carried out by a Consultant Colorectal Surgeon at University College London with a great deal of experience and who is equipped to deal with any issues should they arise. Perforation through the bowel wall or bleeding from biopsy sites are the main risks, but both complications are very rare and only happen in about 1 in every 1,500 examinations. If these occur the Surgeon is experienced in dealing with them. A small proportion of participants may experience anxiety or mild discomfort during the procedure. Experienced medical professionals will monitor participants throughout. Participants will also be provided with feedback on the flexible sigmoidoscopy results. All participants will have their travel expenses reimbursed.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
July 2013 to July 2014
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr Rebecca Beeken
r.beeken@ucl.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
A14133
Study information
Scientific title
Intervening to reduce colorectal cancer risk (INTERCEPT-C): a feasibility study to explore the impact of diet-induced weight loss on biomarkers for colorectal cancer
Acronym
Study hypothesis
Diet-induced weight loss will be associated with changes in the serum and tissue markers related to colorectal cancer risk.
Ethics approval
NRES Committee London, Harrow, 07/03/2013
Study design
Non-randomised single arm exploratory interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Colon cancer, obesity
Intervention
The trialists have designed a weight loss intervention that combines an low calorie diet (LCD~800 calories per day) using the Cambridge Weight Plan products with additional behaviour change techniques from the Shape Up weight management programme developed by the charity Weight Concern. The trialists believe this combined approach will help maximise sustained weight loss and participant well-being. Participants will be on the complete meal replacement programme for 8 weeks this will be followed by 4 weeks in which real food is re-introduced alongside the meal replacement products. Participants will get support and advice on behaviour change on a weekly basis from a Research Psychologist/Dietitian at UCL. Participants will also be weighed at these appointments.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The following tissue and serum samples will be analysed to measure changes in the levels of cancer-related molecular risk markers:
1. Serum insulin, glucose, total IGFI, IGFBP3, leptin, adiponectin and CRP.
2. Colon epithelial cell mRNA levels (as a measure of gene expression) of insulin/IGF/mTOR and adipokine/inflammatory signaling pathways
3. Colon epithelial cell protein levels of activated (phosphorylated) components of the insulin/IGF/mTOR and inflammatory signalling pathways
Measured at baseline and 8 week follow up.
Secondary outcome measures
1. Weight
2. Waist and hip circumference
3. Body mass index
4. Body fat (estimated using a Tanita Body Fat Scale)
5. Blood pressure
6. General health (General Health Questionnaire; GHQ28,Goldberg & Hillier, 1979)
7. Self-esteem (Rosenberg Self Esteem; RSE Scale, Rosenberg, 1965)
8. Body dissatisfaction (Body Shape Questionnaire; BSQ, Evans & Dolan, 1993)
9. Cognitive restraint over eating, disinhibited eating, and susceptibility to hunger (ThreeFactor Eating Questionnaire; TFEQ, Stunkard & Messick, 1985)
10. Binge eating (Binge Eating Scale; BES, Gormally, Black, Daston, & Rardin, 1982)
11. Depression (Centre for Epidemiologic Studies Depression Scale; CESD, Devins, Orme, Costello, & Binik, 1998)
Measured at baseline and 8 week follow up.
Overall trial start date
15/07/2013
Overall trial end date
14/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Body mass index (BMI) ≥30
2. Aged 18-60
3. Non-smoker
4. Fluent in English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. History of major depression
2. History of cardiovascular disease (CVD)
3. Pregnant
4. Taking medication prescribed by a general practitioner over the past month (excluding oral contraceptives)
5. Diabetic
6. Has a disease of the liver, kidney, heart, lung, blood or skin
7. Has had intestinal surgery
8. History of malabsorption
9. Regularly use drugs with anti-inflammatory or antidiabetogenic properties
10. Previous diagnosis of cancer
11. Known food allergies (including lactose intolerance)
Recruitment start date
15/07/2013
Recruitment end date
14/07/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK); Ref: A14133
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Cambridge Weight Plan (UK) are providing the meal replacement products for the study
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list