Healthy, no Evidence of Disease
Conditions
Keywords
healthy, no evidence of disease
Brief 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).
Interventions
DIETARY_SUPPLEMENTcurcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule
GENETICelectrophoretic mobility shift assay
OTHERlaboratory biomarker analysis
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Magnitude of Change in Blood Lymphocyte NF-kB Level | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Biomarker Alterations by Nutritional Labels |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: 15 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biomarker Alterations by Nutritional Labels | The Magnitude of Change in Blood Lymphocyte NF-kB Level | -40.51 Optical Density unit |