Effects of a Western-type Diet on Colorectal Inflammation

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Rockefeller University

Status and phase

Early Phase 1


Colorectal Inflammation


Dietary Supplement: Western style diet (high fat and low in calcium)
Dietary Supplement: Prudent-style diet (low fat and high in calcium)

Study type


Funder types




Details and patient eligibility


This study will look at the inflammatory (changes usually associated with infection/injury to the body) and bowel permeability (bowel's ability to allow contents to enter the body) effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low fat and high in calcium) on the colon (large bowel). This study may provide information to prevent colorectal cancer in a high-risk population

Full description

Hypothesis: Compared to a prudent-style diet, does a western-style diet increase colorectal inflammation thereby increasing gut permeability and causing increased endotoxins and markers of systemic inflammation. This is a single blind crossover study. Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days. The following study measures are performed during both the dietary intervention study periods. All the baseline tests will be repeated at the end of each dietary intervention period.


5 patients




50 to 72 years old


No Healthy Volunteers

Inclusion criteria

  • Healthy male or post-menopausal ( 2 years after menopause or stopping HRT)healthy female subjects
  • Age between 50 and 72 years
  • At increased risk for colorectal cancer (this includes those have had a colorectal adenoma excised, or have a first or second degree relative with colorectal neoplasia).

Exclusion criteria

  • Personal history of cancer other than non-melanoma skin cancer within the past 10 years
  • History of hereditary non-polyposis colon cancer
  • Intestinal malabsorption, inflammatory bowel disease
  • Prior gastrointestinal surgery other than appendectomy or surgery of the esophagus
  • Any excess bleeding or coagulation disorders
  • Subjects taking anti-coagulants, sterol-binding resins, NSAIDs other than aspirin, < 600mg per day, other study medications, or other multiple medications that might, in the view of the study physicians, alter colonic function or inflammation
  • Total cholesterol greater than 240mg/dl, triglycerides > 600mg, LDL-C > 175
  • Subjects with a history of coronary artery disease
  • HIV positive subjects
  • Subjects taking antibiotics, anti-diabetes, hormone replacement therapy, oral, transplanted or injected contraceptives (thyroid hormone therapy is permitted as long as the subject is euthyroid)
  • Currently participating in other clinical studies or completed participation in other clinical studies within the last 30 days

Trial design

Primary purpose

Basic Science



Interventional model

Crossover Assignment


Single Blind

5 participants in 2 patient groups

Western style diet
Active Comparator group
high-fat, low-calcium diet
Dietary Supplement: Western style diet (high fat and low in calcium)
Prudent diet
Active Comparator group
low-fat, calcium-sufficient diet
Dietary Supplement: Prudent-style diet (low fat and high in calcium)

Trial contacts and locations



Data sourced from clinicaltrials.gov

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