A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants - Full Text View

Sponsors and Collaborators:	Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00768118

Purpose

RATIONALE: Studying samples of blood and urine from healthy participants receiving antioxidant nutritional supplements may help doctors identify changes in biomarkers related to oxidative stress.

PURPOSE: This clinical trial is studying how well a nutritional supplement capsule containing curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract works in healthy participants.

Condition	Intervention
Healthy, no Evidence of Disease	Drug: curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule Procedure: electrophoretic mobility shift assay Procedure: laboratory biomarker analysis

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Curcumin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention
Official Title:	A Pilot Study of Biomarker Alterations By Nutritional Agents

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

The magnitude of change in blood lymphocyte NF-kB level [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	April 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To assess the effect of a specific combination nutritional capsule containing curcumin, green tea extract, Polygonum cuspidatum extract, and soybean extract on a specific biomarker of relevance to oxidative stress (NF-κB).
To estimate the mean change in blood lymphocyte NF-κB level before and after 2 weeks of consumption of the nutritional agent under study.

OUTLINE: Participants receive oral curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule twice daily for 2 weeks. Participants are asked to keep a pill diary to track compliance.

Blood and urine samples are collected from participants at baseline and after completion of study. Lymphocytes and serum from the blood samples are isolated and analyzed for NF-κB biomarker levels. Urine samples are also tested for oxidative stress marker levels. Samples are analyzed using an electrophoretic mobility shift assay (EMSA).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Healthy volunteers who are employees of Karmanos Cancer Institute, Wayne State University, or Detroit Medical Center

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768118

Sponsors and Collaborators

Barbara Ann Karmanos Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Fazlul H. Sarkar, PhD

Barbara Ann Karmanos Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000597010, WSU-2007-109, WSU-0211508MIE
Study First Received:	October 4, 2008
Last Updated:	October 4, 2008
ClinicalTrials.gov Identifier:	NCT00768118
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

healthy, no evidence of disease

Study placed in the following topic categories:

Curcumin
Healthy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009