A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants
|ClinicalTrials.gov Identifier: NCT00768118|
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : May 12, 2014
Last Update Posted : June 23, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Biomarker Alterations By Nutritional Agents|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Experimental: Curcumin, Green Tea extract, Polygonum Cuspidatum & Soybean
Total number of visits: 2, pre-intervention blood draw and urine sample collection, post-intervention blood draw and urine sample collection and interview Length of each visit: 15-30 minutes Total expected duration of participants' involvement: 15 days During the two-week intervention, volunteers will take two 1/2g capsules of the combination capsule, twice daily immediately after morning and evening meals.
|Dietary Supplement: curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule Genetic: electrophoretic mobility shift assay Other: laboratory biomarker analysis|
- The Magnitude of Change in Blood Lymphocyte NF-kB Level [ Time Frame: 15 days ]The target accrual goal is 15 subjects. It is hoped that of those 15, at least 10 will be intervention compliant, and provide both planned blood samples. NF-kB levels will be measured using a supershift assay, which tests the specificity and level of NF-kB in the sample by measuring the optical density of a scan. With 10 patients, the mean difference in blood lymphocyte NF-kB level could be estimated to within 0.44 standard 7 deviations, with 80% confidence. That is reasonable precision and confidence level for a small pilot study, and should provide sufficiently precise estimates for use in planning a subsequent study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768118
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Fazlul H. Sarkar, PhD||Barbara Ann Karmanos Cancer Institute|