Healthy, no Evidence of Disease Clinical Trial
Official title:
A Pilot Study of Biomarker Alterations By Nutritional Agents
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.
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).
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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