NCT00768118

A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants

A Pilot Study of Biomarker Alterations By Nutritional Agents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule
GENETIC	electrophoretic mobility shift assay
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-10-07
• Last updated: 2014-06-23
• Results posted: 2014-05-12

Locations

1 site across 1 country: United States