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Trial record 19 of 164 for:    Enzyme | curcumin

Curcumin Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333917
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : February 7, 2013
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Curcumin C3 tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Curcumin Chemoprevention of Colorectal Neoplasia
Study Start Date : November 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Curcumin
4g Curcumin C3 tablet daily
Drug: Curcumin C3 tablet
4 grams Curcumin C3 tablet daily x30 days

Primary Outcome Measures :
  1. Gene expression [ Time Frame: 30 days ]
    Change in gene expression

  2. Ribonucleic acid (RNA) level [ Time Frame: 30 days ]
    Transcript level as mRNA copies per cell

  3. Apoptosis [ Time Frame: 30 days ]
    Immunohistochemistry (IHC) signal as intensity and proportion of cells stained

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 40 - 80.
  2. A willingness to follow the study protocol, as indicated by provision of informed consent to participate
  3. Good general health

Exclusion Criteria:

  1. Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
  2. Ulcerative colitis or Crohn's disease.
  3. History of large bowel resection for any reason
  4. Diagnosed narcotic or alcohol dependence
  5. Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.
  6. Allergy to turmeric/curcumin.
  7. Women with childbearing potential who do not agree to practice effective birth control.
  8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
  9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
  10. Women who are pregnant or nursing.
  11. Individuals who have taken antibiotics within the three months prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333917

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United States, North Carolina
UNC Department of Family Medicine
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Gary N Asher, MD, MPH University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01333917    
Other Study ID Numbers: 10-1524
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: January 2013
Keywords provided by University of North Carolina, Chapel Hill:
Colorectal Cancer
Additional relevant MeSH terms:
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Enzyme Inhibitors
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action