Colorectal Inflammatory Response to a Western-Style Diet
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators are involved in a research program to understand how different diets may
      affect the risk of colorectal polyps and cancer. To that end, the investigators are
      conducting a study of a western style diet versus a "prudent style" diet in which volunteer
      subjects are provided a different diet for 2 separate 4 week periods at the Rockefeller
      University Hospital. During one of these 4 week inpatient periods they receive a Western
      style diet and during the other 4 week inpatient period they receive a "Prudent style" diet.
      The investigators will determine changes within the colon as a result of the two different
      diets. A more detailed description of the study is provided below.
    

Detailed description: 
      Study subjects participate for about 3 months. During this time, there is one outpatient
      visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and
      finally another 4 week inpatient period. During the inpatient periods The Rockefeller
      University Hospital becomes your home the subject must sleep here every night and consume all
      the food provided. During the screening visit blood and urine samples will be taken and an
      EKC (electrocardiogram) and a complete physical exam will be done. After enrollment into the
      study, the first 4 week inpatient period begins. You may continue to go to work or do other
      activities as long as you eat the diet provided and sleep at the Rockefeller University
      Hospital. You must eat everything that we give you and you may not substitute or supplement
      the diet in any way. During each 4 week stay at The Rockefeller University Hospital, there
      will be three flexible sigmoidoscopies done and biopsies taken of the mucosal lining of the
      colorectum. This procedure is painless and takes about 5 minutes. In addition, blood and
      stool samples will be taken every few days for follow-up and research, two 24 hour urine
      samples will be done on separate days during the hospitalization. Vital signs are measured
      every day and your weight will be measured three times per week. During the four week wash
      out period, the subject will return to their home, go about their normal activities and
      consume their normal diet. The subject will return to The Rockefeller University Hospital for
      the second 4 week inpatient period. The procedures and laboratory tests are the same during
      the second inpatient period. The study concludes with the subjects discharge from the RUH.
    

Intervention name(s): Western-style diet (WD); Prudent Diet (PD)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Will comprise of approximately 40% fat, 40% carbohydrates, 20% protein, and 350mg calcium, prepared by the Bionutrition Department using the USDA Nutrient Database.; Will contain approximately 20% fat, 60% carbohydrate, 20% protein, and 1100mg calcium; the diets will consist of a 2-day rotating metabolic menu.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention