Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diets to American Diet - a Pilot Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2014 by Joslin Diabetes Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Joslin Diabetes Center
Collaborator:
Sunstar, Inc.
Information provided by (Responsible Party):
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00379548
First received: September 21, 2006
Last updated: March 25, 2014
Last verified: March 2014
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Purpose
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:
- To compare the inflammatory responses (primarily PKC activation in monocytes), between Far-East Asian Americans and Caucasian Americans, when they change from a traditional Asian diet to a typical American diet.
- To correlate the biochemical changes of inflammatory responses in the plasma and monocytes with those in the gingival crevicular fluid (GCF).
| Condition | Intervention |
|---|---|
|
Diabetes Insulin Resistance Inflammation Cardiovascular Disease Periodontal Disease |
Behavioral: 2 groups of population responding to 2 types of diets |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Pilot Study of the Changes in Inflammatory State in Asian Americans Changing From Traditional Asian Diet to Typical American Diets |
Resource links provided by NLM:
Further study details as provided by Joslin Diabetes Center:
Primary Outcome Measures:
- Changes in inflammatory markers including PKC and IL6 and Gingival Crevicular Fluid [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
- Lipid profiles [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
- Blood glucose levels [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
- Body Fat percentage assessed by Dual X-ray Absorption [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
- Insulin resistance assessed by HOMA [ Time Frame: before Asian Diet, after 8 weeks of Asian Diet, after 8 weeks of Western Diet ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Control group- subjects are on the Asian diet for the entire duration of the study
|
|
|
Experimental: 2
Asian and Caucasian subjects switch from an Asian Diet to a Western Diet midway through the study.
|
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.
|
Eligibility| Ages Eligible for Study: | 25 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Caucasian or Far-East Asian decent
- Ages between 25 - 55 years old
- Has family history of diabetes defined as having a first degree relative diagnosed with diabetes mellitus, and/or medical history of gestational diabetes (GDM), impaired fasting glucose(IFG) and impaired glucose tolerance (IGT)
- BMI of 18.5 - 25.0 kg/m2
- Agree to maintain constant physical activity levels for the duration of the study
- Agree to utilize contraception for the duration of the study (for female subjects)
- Have a minimum of 12 natural teeth
- Scoring of 2 or more on dental screening questionnaire (See appendix)
- Ability to communicate in English
Exclusion Criteria:
- Acute weight loss/weight gain over the past 6 months (defined as +4 lbs or more/month)
- History of diabetes
- Current Smokers (including those who quit < 1 year)
- Heavy alcohol drinkers, defined as drinking more than 7 drinks/week. Those who drink alcohol will need to be reported and documented. They will be asked to maintain the levels of alcohol consumption throughout the study.
- Medical history of vascular diseases (CAD, MI, stroke, CABG, angioplasty), diabetes, liver disease, kidney disease, cancer, AIDS, bleeding disorders
- History of food allergies or to any food products in the diet menu.
- Enrolled in another investigational study within 1 month prior to screening for this study
- Vegetarian, those with significant food aversions, and anyone who cannot comply with the diet
- Pregnancy or breasting feeding
- Other autoimmune or inflammatory conditions or diseases that may compromise the patient's safety or compliance during the study on an individual basis
- Chronic use of antibiotics or anti-inflammatory medications (>1 month) within the past year
- On medications such as statins, angiotensin converting enzyme inhibitor, warfarin, aspirin or other anti-inflammatory medications. Daily multivitamins are permitted, excluding pharmacological doses of anti- oxidants will not be allowed.
- Individuals with dental needs requiring extensive dental restorations such as cavities, root canals, crowns, etc.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379548
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379548
Locations
| United States, Massachusetts | |
| Joslin Diabetes Center | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Joslin Diabetes Center
Sunstar, Inc.
Investigators
| Principal Investigator: | George L King, MD | Joslin Diabetes Center |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Joslin Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT00379548 History of Changes |
| Other Study ID Numbers: | 04-47 |
| Study First Received: | September 21, 2006 |
| Last Updated: | March 25, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Inflammation Cardiovascular Diseases Insulin Resistance Periodontal Diseases Gingival Diseases Pathologic Processes |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on September 27, 2016