NCT00768118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

May 12, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

5 months

First QC Date

October 4, 2008

Results QC Date

April 10, 2014

Last Update Submit

June 10, 2014

Conditions

Healthy, no Evidence of Disease

Keywords

healthy, no evidence of disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Dietary Supplement: curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsuleGenetic: electrophoretic mobility shift assayOther: laboratory biomarker analysis

Interventions

curcumin/green tea extract/Polygonum cuspidatum extract/soybean extract capsuleDIETARY_SUPPLEMENT
Curcumin, Green Tea extract, Polygonum Cuspidatum & Soybean
electrophoretic mobility shift assayGENETIC
Curcumin, Green Tea extract, Polygonum Cuspidatum & Soybean
laboratory biomarker analysisOTHER
Curcumin, Green Tea extract, Polygonum Cuspidatum & Soybean

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Interventions

CurcuminElectrophoretic Mobility Shift Assay

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicElectrophoresisChemistry Techniques, AnalyticalInvestigative Techniques

Limitations and Caveats

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.

Results Point of Contact

Title
Fazlul Sarkar, Ph.D.
Organization
Barbara Ann Karmanos Cancer Institute
sarkarf@karmanos.org
(313) 576-8327

Study Officials

  • Fazlul H. Sarkar, PhD

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2008

First Posted

October 7, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 23, 2014

Results First Posted

May 12, 2014

Record last verified: 2014-06

Locations

US(1)