INTERCEPT-C: weight loss and colorectal cancer risk

ISRCTN	ISRCTN35702367
DOI	https://doi.org/10.1186/ISRCTN35702367
Secondary identifying numbers	A14133

Submission date: 16/10/2013
Registration date: 06/12/2013
Last edited: 22/01/2019

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Jane Wardle
Scientific

University College London
Health Behaviour Research Centre
Department of Epidemiology and Public Health
1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Study information

Study design	Non-randomised single arm exploratory interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study objectives	Diet-induced weight loss will be associated with changes in the serum and tissue markers related to colorectal cancer risk.
Ethics approval(s)	NRES Committee London, Harrow, 07/03/2013
Health condition(s) or problem(s) studied	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
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 study start date	15/07/2013
Completion date	14/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	1. Body mass index (BMI) ≥30 2. Aged 18-60 3. Non-smoker 4. Fluent in English
Key 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)
Date of first enrolment	15/07/2013
Date of final enrolment	14/07/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London

London
WC1E 6BT
United Kingdom

Sponsor information

University College London (UK)
University/education

c/o David Wilson
Research Support Centre
1st Floor, Maple House Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK (UK); Ref: A14133
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Cambridge Weight Plan (UK) are providing the meal replacement products for the study

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2017	22/01/2019	Yes	No

Editorial Notes

22/01/2019: Publication reference added
06/02/2017: No publications found, verifying study status with principal investigator.