A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants
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.
Healthy, no Evidence of Disease
Dietary Supplement: curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule
Genetic: electrophoretic mobility shift assay
Other: laboratory biomarker analysis
|Study Design:||Primary Purpose: Prevention|
|Official Title:||A Pilot Study of Biomarker Alterations By Nutritional Agents|
- The magnitude of change in blood lymphocyte NF-kB level [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- 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).
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Fazlul H. Sarkar, PhD||Barbara Ann Karmanos Cancer Institute|