Effects of a Western-type Diet on Colorectal Inflammation

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Rockefeller University

Status and phase

Completed
Early Phase 1

Conditions

Colorectal Inflammation

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00866450
SWP-0658

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

50 to 72 years old

Volunteers

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

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

5 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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