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


Phase 2
35 Years
75 Years
Not Enrolling
Male
Adenomas, Colorectal Adenoma, Colon Adenomas

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Trial Information

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


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 itself, and prevention of adenomas will most likely prevent colorectal
cancer. Insulin resistance and type 2 diabetes are emerging as significant risk factors for
colorectal (CRC) cancer and adenomas. Insulin resistance is defined as impaired biological
response to the action of insulin. It is characterized by compensatory hyperinsulinemia and
is associated with increased risk for Type 2 diabetes. C-peptide, a marker of insulin
production, is elevated in IR and is also a risk factor for CRC. Both insulin resistance and
colorectal cancer are increasingly recognized as chronic, low-level, inflammatory states.
C-reactive protein (CRP), an acute phase protein and a sensitive marker of sub-clinical
inflammation, is a risk factor for both IR and CRC.

Analysis from the Polyp Prevention Trial (PPT), a multi-center, randomized trial of 1905
participants who had a colorectal adenoma, showed that legume consumption was significantly
associated with reduction of both adenoma recurrence and advanced adenoma recurrence.
Legumes are a rich source of dietary fibers and anti-inflammatory, anti-cancer
phytochemicals.

We are evaluating the effects of a legume enriched, low glycemic index, high fermentable
fiber diet, on CRP, (a measure of inflammation) and C-peptide (a measure of insulin
resistance) in participants with four possible combinations of the risk factors insulin
resistance and history of adenomatous polyps. In a randomized crossover design controlled
feeding study each participant consumed the above experimental diet and a control diet for
four weeks with a two week washout period between diets. 65 male participants were recruited
and randomized into four groups. A secondary objective is to assess whether these endpoints
change by IR status or a history of adenomas. In addition, potential fecal markers of CRC
risk are being measured to assess changes in gastrointestinal inflammation, including mRNA
from exfoliated fecal colonocytes. To our knowledge this is the first controlled feeding
study: 1. to examine the effects of legumes or a low GI diet on markers of inflammation; 2.
to compare the effects of a dietary intervention on patients with a history of colon
adenomas with or without IR; and 3. to measure the effects of dietary changes in human
intestinal gene expression profiles using exfoliated colonocytes.

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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Evaluate the effects of a high legume, low glycemic index diet on serum C-reactive protein (CRP).

Principal Investigator

Matthew R Young, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999905215

NCT ID:

NCT00339469

Start Date:

August 2005

Completion Date:

May 2008

Related Keywords:

  • Adenomas
  • Colorectal Adenoma
  • Colon Adenomas
  • Colon
  • Satiety
  • Fecal Colonocytes
  • C-Reactive Protein
  • Controlled Diet
  • Adenoma

Name

Location

Pennsylvania State UniversityHershey, Pennsylvania  17033