Clinical trial · Interventional
Colorectal Inflammatory Response to a Western-Style Diet
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prudent Diet (PD) | Dietary Supplement | — | UNRESOLVED |
| Western-style diet (WD) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Western-style, high-fat, low-calcium diet (WD)
- interventionNames
- Dietary Supplement: Western-style diet (WD)
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Prudent, low-fat, calcium sufficient diet (PD)
- interventionNames
- Dietary Supplement: Prudent Diet (PD)
Primary outcomes (1)
- measure
- The degree of inflammation in the rectosigmoid epithelium as judged by the density and composition of the cellular infiltration.
- timeFrame
- Day 1 and Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy male and post-menopausal healthy female subjects, aged 50-72 years, who have had a colorectal adenoma removed, or have a first or second degree relative with colorectal neoplasia and thus are themselves at risk for colorectal cancer. 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 of inflammation * Sustained blood pressure \> 150/95 mm Hg for three consecutive readings * Total cholesterol greater than 240mg/dL, triglycerides \>600mg, LDL-C \> 175 * Subjects with a history of coronary artery disease, with EKG changes consistent with a past myocardial infarction * 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 subjects is euthyroid) * Subjects consuming a vegetarian diet or a very "prudent diet" Withdrawal Criteria: * If a subject is suspected of having taken illicit drugs, the subject will be asked to take a urine test. If positive, the subject will be withdrawn from the study * The subject takes any medication prescribed without prior approval of the investigator * Persistent noncompliance with the diets prescribed by the RUH nutritionists
References
Publications (0)
Data not yet available