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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Preventive Study of a High Legume, Low Glycemic Index Diet in Patients at High Risk for Colorectal Adenoma Recurrence

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Prevention Active Adult NCI NCI-05-C-N215 05-C-N215, NCT00339469

Special Category: NIH Clinical Center trial

Trial Description

Purpose:

A diet that is high in dried beans (legumes) may reduce the levels of insulin, glucose, and markers of inflammation in men with colorectal cancer who are at risk of cancer recurrence.

This clinical trial is studying a high legume diet in preventing cancer in men at high risk of recurrent colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Previous diagnosis of colorectal cancer and/or a history of colorectal polyps
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will be given food to eat for up to three 4-week diet periods. During the first 4-week period, participants will eat a healthy, typical American diet while maintaining their body weight. During the second 4-week period, participants will eat 1½ cups of cooked legumes (such as pinto beans, baked beans, or navy beans) each day and a healthy diet while maintaining their body weight. During the third 4-week period, participants will again eat 1½ cups of cooked legumes each day and a healthy diet, but weight loss is allowed.

Patients will undergo stool, urine, and blood sample collection for laboratory studies after the second and third diet periods.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Amanda Cross, PhD, Principal investigator		Ph: 301-496-4378

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937
Pennsylvania
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		Clinical Trials Office - Penn State Cancer Institute at Milton S. Hershey Medical Center	Ph:  717-531-3779
			Email: CTO@hmc.psu.edu

Registry Information
Official Title		The Effects of a High Legume Low Glycemic Index Diet on Insulin Resistance and Inflammation in Patients at High Risk for Colorectal Adenoma Recurrence
Trial Start Date		2005-08-01
Registered in ClinicalTrials.gov		NCT00339469
Date Submitted to PDQ		2007-06-11
Information Last Verified		2008-12-21