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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Pilot Study of Biomarker Alterations By Nutritional Agents

Conditions
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Healthy, no Evidence of Disease

Intervention / Treatment
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* Dietary Supplement: curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule
* Genetic: electrophoretic mobility shift assay
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Healthy volunteers who are employees of Karmanos Cancer Institute, Wayne State University, or Detroit Medical Center PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin, Green Tea extract, Polygonum Cuspidatum & Soybean<br>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<br> <br> Genetic: electrophoretic mobility shift assay<br> <br> Other: laboratory biomarker analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Magnitude of Change in Blood Lymphocyte NF-kB Level | 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. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy, no evidence of disease