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A Pilot Study of Biomarker Alterations By Nutritional Agents


N/A
18 Years
N/A
Not Enrolling
Both
Healthy, no Evidence of Disease

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Trial Information

A Pilot Study of Biomarker Alterations By Nutritional Agents


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).

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Outcome Measure:

The magnitude of change in blood lymphocyte NF-kB level

Safety Issue:

No

Principal Investigator

Fazlul H. Sarkar, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000597010

NCT ID:

NCT00768118

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease
  • healthy, no evidence of disease

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201