INTERCEPT-C: weight loss and colorectal cancer risk

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35702367

Enrollment

Registered

2013-12-06

Start date

2013-07-15

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer, obesity Cancer Malignant neoplasm of colon

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026