Status:
COMPLETED
Effect of High-Legume Diet on Colorectal Cancer Risk
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Inflammation
Prevention and Control
Eligibility:
MALE
35-75 years
Phase:
EARLY_PHASE1
Brief Summary
This study, sponsored by the National Cancer Institute and Penn State University, will examine how a diet high in legumes (dried beans) influences risk factors for colon cancer and polyps. Many scient...
Detailed Description
Clinical, epidemiological, and molecular studies provide compelling evidence that most colorectal cancers arise from adenomas. The epidemiology of adenomas closely resembles that of colorectal cancer ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Subjects are between 35-75 years old.
- Subjects are male.
- Subjects have a BMI 25.0-34.9 kg/m(2)
- Group 1 (adenoma, IR)
- Subjects had a colonoscopy within the last two years
- Subjects who had had one or more histologically confirmed adenomas removed from the colon during a colonoscopy in the last two years, in which the cecum was visualized, all polyps were removed, and the bowel was adequately prepared.
- Subjects have had either an adenoma previous to the above colonoscopy or multiple adenomas during the above colonoscopy.
- Subjects should have more than one previous adenoma in the colon. Rectal adenomas will be excluded. (If a person has only rectal adenomas or 1 colon and numerous rectal adenomas they will be excluded from the study, since the epidemiology for rectal and colon adenomas differ)
- Subjects are insulin resistance as determined by the Homeostasis Assessment Model (HOMA-IR), a mathematical model which allows values for insulin sensitivity and beta-cell function (expressed as percent of normal) to be obtained from simultaneous fasting plasma glucose and fasting insulin. HOMA-IRA is calculated by fasting serum insulin (FI in uU/mL); fasting glucose (FG in mmol/L) / 22.5 or HOMA-IR = FIxFG/22.5 (188). Values greater than or equal to 2.61 are considered insulin resistant
- Group 2 (adenomas, non IR)
- Subjects had a colonoscopy within the last two years.
- Subjects had one or more histologically confirmed colorectal adenomas removed during a colonoscopy in the last two years in which the cecum was visualized, all polyps were removed, and the bowel was adequately prepared.
- Subjects have had either an adenoma previous to the above colonoscopy or multiple adenomas during the above colonoscopy.
- Subjects should have more than 1 adenoma in the colon (vs rectum).
- Subjects are not insulin resistance as determined by HOMA-IR.
- Group 3 (no adenoma, IR)
- Subjects (controls) had a colonoscopy within the last two years and who had no histologically confirmed colorectal adenomas during the colonoscopy, in which the cecum was visualized and the bowel was adequately prepared.
- Subjects have had no previous adenoma.
- Subjects are insulin resistant as determine by HOMA-IR.
- Group 4 (no adenoma, non IR)
- Subjects (controls) had a colonoscopy within the last two years and had no histologically confirmed colorectal adenomas during the colonoscopy, in which the cecum was visualized and the bowel was adequately prepared.
- Subjects have had no previous adenomas.
- Subjects are not insulin resistance as determined by HOMA-IR.
- EXCLUSION CRITERIA
- All Subjects
- A serious medical condition such as cancer, heart disease, kidney disease, diabetes or other serious medical condition.
- A history of colorectal cancer, surgical resection of adenomas, bowel resection, the polyposis syndrome, or inflammatory bowel disease.
- Smoked regularly in the past year.
- Have a medical condition or dietary restrictions or practices that would substantially limit compliance with the dietary protocol.
- Planning on changing diet, exercise or other health behavior in the next 6 months.
- Taking any medication that may alter inflammation markers, insulin, glucose, and lipids.
- Potential participants should not be regularly using the following preparations:
- Antibiotics
- Non-steroidal anti-inflammatory drugs (aspirin and other non-aspirin NSAIDS like inbuprofen, naproxen, indomethacin, piroxicam, COX-2-specific inhibitor drugs such as celecoxib, etodolac, and meloxicam)
- Glucocorticoids and other steroids
- Oral glucose preparations (e.g. Actos, Amaryl, Avandia, DiaBeta, Diabinese, Dymelor, Glucophage(XR), Glucotrol(XL), Glucovance, Glynase Pres Tab, Glyset, Micronase, Orinase, Prandin, Precose, Starlix, Tolinase)
- Insulin injections
- Statins (e.g. atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin)
- Bile Acid Resins (e.g. cholestyramine, colestipol, colesevelam)
- Nicotinic Acid (Niacin)
- Fibrates (e.g. clofibrate, fenofibrate, gemfibrozil)
- Combination Lipid Lowering Drugs (e.g. Crestor)
- Participants will be asked not to use any supplements (including herbal and alternative therapies) other than a regular multi-vitamin/mineral while participating in the study. While we ask subjects to stop use of OTC medications during the study, we recognize that there may be occasional use of OTC analgesics during the course of the study. At least under some circumstances we will permit the use of OTC analgesics, which is otherwise listed as an exclusion criteria. At their scheduled blood draws, we will ask subjects to report any use of OTC medications during the past week. Participants will also be asked to limit their use of alcohol during the study to less than or equal to 2 drinks/week.
Exclusion
Key Trial Info
Start Date :
August 3 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00339469
Start Date
August 3 2005
End Date
February 13 2018
Last Update
December 16 2019
Active Locations (1)
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1
Pennsylvania State University
University Park, Pennsylvania, United States, 16802