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NCT00339469 · ClinicalTrials.gov registry record · Early Phase 1
Effect of High-Legume Diet on Colorectal Cancer Risk
A Early Phase 1 study of Inflammation and Diet, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT00339469: Completed Early Phase 1 study of Inflammation and Diet, sponsored by National Cancer Institute (NCI).
NCT00339469 is a Early Phase 1 study of Inflammation and Diet that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 65 participants, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00339469, a Early Phase 1 study of Inflammation and Diet, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study 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 scientists believe that colon and rectal cancers develop from polyps (tumors of the lining of the large bowel). This study will test whether a high-legume diet can reduce levels of certain factors (blood insulin, blood glucose, and markers of inflammation such as C-reactive protein) that at elevated levels are known to increase the risk of colorectal polyps and colon cancer. Healthy men between 35 and 75 years of age may be eligible for this study, conducted at Penn State University in University Park, Pennsylvania. Candidates are screened with blood tests and measurements of height, weight, and blood pressure. All candidates must have had a colonoscopy within 2 years of entering the study. They may or may not have had adenomas and may or may not be insulin-resistant. Candidates must not have cancer, heart disease, kidney disease, diabetes, or other serious medical condition, and they must have no history of colorectal cancer, polyp removal, bowel surgery, polyposis syndrome, or inflammatory bowel disease. Participants undergo the following tests and procedures: * Caloric requirement testing: The subject's resting metabolic rate is measured while fasting and in the early morning at rest to determine daily calorie requirement before beginning the study diet. A special clear plastic hood is placed over the subject's head while his breathing is measured. He can communicate with the technician at all times during the 30-minute test. * Study diet: Subjects follow two required 4-week diets with a 3-week break in between, followed by an optional third 4-week diet. Subjects eat a healthy American diet for both of the required 4-week diet periods; about 1-1/2 cups of cooked legumes, such as pinto, baked, and navy beans are added to one of the two required diets. For the third (optio
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT LIFE
Study Locations (1)
Pennsylvania
- Pennsylvania State University - University Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2005-08-03 |
| Est. Completion | 2018-02-13 |
| Phase | Early Phase 1 |
What the finished NCT00339469 record still lists
NCT00339469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (77% lower).
The record links to 5 conditions, with Inflammation appearing as the primary indexed condition, and to 1 intervention - of which LIFE is the first listed.
NCT00339469 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00339469 about?
NCT00339469 is a clinical study titled "Effect of High-Legume Diet on Colorectal Cancer Risk". 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 scientists believe that colon and rectal cancers develop from polyps (tumors of the lining of the large bo...
What is the current status of trial NCT00339469?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 65 participants. The study started on 2005-08-03. Estimated completion is 2018-02-13.
What conditions does trial NCT00339469 study?
This clinical trial studies the following conditions: Inflammation, Diet, Colonic Neoplasms, Insulin, Prevention and Control.
What interventions are being tested in trial NCT00339469?
The interventions under investigation include: LIFE (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00339469?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00339469 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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