A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants
Summary
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.
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).
Study Design
Primary Purpose: Prevention
Conditions
Healthy, no Evidence of Disease
Intervention
curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule, electrophoretic mobility shift assay, laboratory biomarker analysis
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00768118
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Thyroid Extract, Desiccated
A dehydrated extract of thyroid glands. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.
Thyroid (usp)
A dehydrated extract of thyroid glands from domesticated animals. After the removal of fat and connective tissue, the extract is dried or lyophilized to yield a yellowish to buff-colored amorphous powder containing 0.17-0.23% of iodine.
Cannabidiol
Compound isolated from Cannabis sativa extract.
Harpagophytum
A plant genus of the family PEDALIACEAE. Members contain harpagoside and are the source of extract WS 1531.
Sanguinaria
A plant genus of the family PAPAVERACEAE. S. canadensis is the source of sanguinarine extract used in MOUTHWASHES.
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