The Effects of a High Legume Low Glycemic Index Diet on Insulin Resistance and Inflammation in Patients at High Risk for Colorectal Adenoma Recurrence

Inclusion Criteria

- INCLUSION CRITERIA

1. Subjects are between 35-75 years old.

2. Subjects are male.

3. Subjects have a BMI 25.0-34.9 kg/m(2)

Group 1 (adenoma, IR)

4. Subjects had a colonoscopy within the last two years

5. 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.

6. Subjects have had either an adenoma previous to the above colonoscopy or
multiple adenomas during the above colonoscopy.

7. 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)

8. 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)

9. Subjects had a colonoscopy within the last two years.

10. 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.

11. Subjects have had either an adenoma previous to the above colonoscopy or
multiple adenomas during the above colonoscopy.

12. Subjects should have more than 1 adenoma in the colon (vs rectum).

13. Subjects are not insulin resistance as determined by HOMA-IR.

Group 3 (no adenoma, IR)

14. 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.

15. Subjects have had no previous adenoma.

16. Subjects are insulin resistant as determine by HOMA-IR.

Group 4 (no adenoma, non IR)

17. 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.

18. Subjects have had no previous adenomas.

19. Subjects are not insulin resistance as determined by HOMA-IR.

EXCLUSION CRITERIA

All Subjects

1. A serious medical condition such as cancer, heart disease, kidney disease, diabetes
or other serious medical condition.

2. A history of colorectal cancer, surgical resection of adenomas, bowel resection, the
polyposis syndrome, or inflammatory bowel disease.

3. Smoked regularly in the past year.

4. Have a medical condition or dietary restrictions or practices that would
substantially limit compliance with the dietary protocol.

5. Planning on changing diet, exercise or other health behavior in the next 6 months.

6. 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.