INTERCEPT-C: weight loss and colorectal cancer risk

Completed

• Conditions: Colon cancer, obesity; Cancer; Malignant neoplasm of colon

• Registration Number: ISRCTN35702367
• Lead Sponsor: niversity College London (UK)

Brief Summary

1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/29086510 (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-06
• Study Completion: 2014-07-14
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Body mass index (BMI) =30
2. Aged 18-60
3. Non-smoker
4. Fluent in English

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The following tissue and serum samples will be analysed to measure changes in the levels of cancer-related molecular risk markers:<br> 1. Serum insulin, glucose, total IGFI, IGFBP3, leptin, adiponectin and CRP.<br> 2. Colon epithelial cell mRNA levels (as a measure of gene expression) of insulin/IGF/mTOR and adipokine/inflammatory signaling pathways<br> 3. Colon epithelial cell protein levels of activated (phosphorylated) components of the insulin/IGF/mTOR and inflammatory signalling pathways<br> Measured at baseline and 8 week follow up.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Weight<br> 2. Waist and hip circumference<br> 3. Body mass index<br> 4. Body fat (estimated using a Tanita Body Fat Scale)<br> 5. Blood pressure<br> 6. General health (General Health Questionnaire; GHQ28,Goldberg & Hillier, 1979)<br> 7. Self-esteem (Rosenberg Self Esteem; RSE Scale, Rosenberg, 1965)<br> 8. Body dissatisfaction (Body Shape Questionnaire; BSQ, Evans & Dolan, 1993)<br> 9. Cognitive restraint over eating, disinhibited eating, and susceptibility to hunger (ThreeFactor Eating Questionnaire; TFEQ, Stunkard & Messick, 1985)<br> 10. Binge eating (Binge Eating Scale; BES, Gormally, Black, Daston, & Rardin, 1982)<br> 11. Depression (Centre for Epidemiologic Studies Depression Scale; CESD, Devins, Orme, Costello, & Binik, 1998)<br> Measured at baseline and 8 week follow up.<br>