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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-2007-109 | |||
| WSU-0211508MIE |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin, Green Tea extract, Polygonum Cuspidatum & Soybean | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule | Dietary Supplement |
| ||
| 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 |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Fazlul H. Sarkar, PhD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biomarker Alterations by Nutritional Labels | Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| electrophoretic mobility shift assay |
| Genetic |
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| laboratory biomarker analysis | Other |
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| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biomarker Alterations by Nutritional Labels | Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 90% Confidence Interval | Optical Density unit | 15 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biomarker Alterations by Nutritional Labels | Participants will donate a blood sample (pre & post intervention), two-3 tsp size tubes of blood will be collected in CPT tubes during each blood draw. Urine sample (pre & post intervention). During the 2-wk intervention period, the participant will be ingesting a nutritional supplement. Two capsules taken orally twice daily with meals, no other tests will be performed. | 0 | 11 | 0 | 11 |
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The study has small numbers, it was a proof-of-concept study only to demonstrate that agents taken orally can alter biomarkers, similar to the results obtained from in vitro studies, it was to open doors for future studies.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fazlul Sarkar, Ph.D. | Barbara Ann Karmanos Cancer Institute | (313) 576-8327 | sarkarf@karmanos.org |
| ID | Term |
|---|---|
| D003474 | Curcumin |
| D024202 | Electrophoretic Mobility Shift Assay |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D004586 | Electrophoresis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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