Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
This study is ongoing, but not recruiting participants.
Sponsor:
Joslin Diabetes Center
Collaborator:
Sunstar, Inc.
Information provided by:
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00379548
First received: September 21, 2006
Last updated: June 22, 2011
Last verified: June 2011
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | September 21, 2006 | ||||
Last Updated Date | June 22, 2011 | ||||
Start Date ICMJE | November 2005 | ||||
Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE |
|
||||
Change History | Complete list of historical versions of study NCT00379548 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study | ||||
Official Title ICMJE | A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets | ||||
Brief Summary | We hypothesize that Asian Americans compared to Caucasians, will be at higher risk of developing a pro-inflammatory state that may contribute to the development of heart disease and diabetes when they change from a traditional Asian diet to a typical Western diet. These inflammatory responses will be reflected by the activation of monocytes as measured by protein kinase C (PKC), a known activator of monocytes. We also hypothesize that the changes of these inflammatory responses in the gingival crevicular fluid (GCF) will reflect similar changes of these markers in the plasma and monocytes. Specific aims:
|
||||
Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Behavioral: 2 groups of population responding to 2 types of diets
Intervention groups include: Asian intervention and Caucasian intervention- both these groups switch from an Asian diet to a Western diet halfway through the study. |
||||
Study Arm (s) |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 70 | ||||
Estimated Completion Date | December 2011 | ||||
Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 25 Years to 55 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00379548 | ||||
Other Study ID Numbers ICMJE | 04-47 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Research Director, Joslin Diabetes Center | ||||
Study Sponsor ICMJE | Joslin Diabetes Center | ||||
Collaborators ICMJE | Sunstar, Inc. | ||||
Investigators ICMJE |
|
||||
Information Provided By | Joslin Diabetes Center | ||||
Verification Date | June 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |