Condition category
Cancer
Date applied
16/10/2013
Date assigned
06/12/2013
Last edited
20/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We know that obesity is a significant health concern, and that obesity 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. Our aim 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 will attend weekly sessions with a Psychologist/Dietitian at University College London where they will receive a complete meal replacement plan and support. Participants will be 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). Blood samples will also be taken at baseline and 8 weeks At baseline and follow-up, they will also 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?
The study will take place between July 2013 and 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

Contact information

Type

Scientific

Primary contact

Prof Jane Wardle

ORCID ID

Contact details

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

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 controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colon cancer, Obesity

Intervention

We 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. We 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes