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Trial record 24 of 80 for:    "curcumin" and "cancer"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00768118
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : May 12, 2014
Last Update Posted : June 23, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fazlul Sarkar, Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Healthy, no Evidence of Disease
Interventions Dietary Supplement: curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsule
Genetic: electrophoretic mobility shift assay
Other: laboratory biomarker analysis
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Biomarker Alterations by Nutritional Labels
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Biomarker Alterations by Nutritional Labels
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title The Magnitude of Change in Blood Lymphocyte NF-kB Level
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biomarker Alterations by Nutritional Labels
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 9
Mean (90% Confidence Interval)
Unit of Measure: Optical Density unit
-40.51
(-59.45 to -21.58)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Biomarker Alterations by Nutritional Labels
Hide Arm/Group Description 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.
All-Cause Mortality
Biomarker Alterations by Nutritional Labels
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Biomarker Alterations by Nutritional Labels
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Biomarker Alterations by Nutritional Labels
Affected / at Risk (%)
Total   0/11 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fazlul Sarkar, Ph.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: (313) 576-8327
EMail: sarkarf@karmanos.org
Layout table for additonal information
Responsible Party: Fazlul Sarkar, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00768118     History of Changes
Other Study ID Numbers: CDR0000597010
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2007-109
WSU-0211508MIE
First Submitted: October 4, 2008
First Posted: October 7, 2008
Results First Submitted: April 10, 2014
Results First Posted: May 12, 2014
Last Update Posted: June 23, 2014