Trial Outcomes & Findings for A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants (NCT NCT00768118)
NCT ID: NCT00768118
Last Updated: 2014-06-23
Results Overview
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.
COMPLETED
NA
11 participants
15 days
2014-06-23
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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11
|
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Overall Study
COMPLETED
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11
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Nutritional Supplement Capsule Containing Curcumin, Green Tea Extract, Polygonum Cuspidatum Extract, and Soybean Extract in Healthy Participants
Baseline characteristics by cohort
| Measure |
Biomarker Alterations by Nutritional Labels
n=11 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
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Region of Enrollment
United States
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11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 15 daysThe 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.
Outcome measures
| Measure |
Biomarker Alterations by Nutritional Labels
n=9 Participants
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.
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|---|---|
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The Magnitude of Change in Blood Lymphocyte NF-kB Level
|
-40.51 Optical Density unit
Interval -59.45 to -21.58
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Adverse Events
Biomarker Alterations by Nutritional Labels
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Fazlul Sarkar, Ph.D.
Barbara Ann Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place