A Pilot Study of Biomarker Alterations By Nutritional Agents
18 Years
N/A
Both
Healthy, no Evidence of Disease
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 Institute | Detroit, Michigan 48201 |
